Cybersecurity Saturday

Cybersecurity Saturday

From the cybersecurity policy and law enforcement front,

  • The White House issued a proclamation yesterday about October being Cybersecurity Awareness Month so let’s go.
  • Per Cyberscoop,
    • “European law enforcement dismantled and seized an expansive cybercrime operation used to facilitate phishing attacks via mobile networks for fraud, including account intrusions, credential and financial data theft, Europol said Friday [October 17].
    • “Investigators from Austria, Estonia and Latvia linked the cybercrime networks to more than 3,200 fraud cases, which also involved investment scams and fake emergencies for financial gain. Financial losses amounted to about $5.3 million in Austria and $490,000 in Latvia, authorities said.
    • “The operation dubbed “SIMCARTEL” netted seven arrests and the seizure of 1,200 SIM box devices, which contained 40,000 active SIM cards that were used to conduct various cybercrimes over telecom networks. Officials described the infrastructure as highly sophisticated, adding that the online service it supported provided telephone numbers for criminal activities to people in more than 80 countries.”
  • and
    • “A Massachusetts man who previously pleaded guilty to a cyberattack on PowerSchool, exposing data on tens of millions of students and teachers, was sentenced to four years in prison Tuesday — half the amount federal prosecutors sought in sentencing recommendations submitted to the court.
    • “Matthew Lane, 20, stole data from PowerSchool belonging to nearly 70 million students and teachers, extorted the California-based company for a ransom, which it paid, causing the education software vendor more than $14 million in financial losses, according to prosecutors.
    • “U.S. District Judge Margaret Guzman sentenced Lane to four years in prison, followed by three years of supervised release. Lane was also ordered to pay almost $14.1 million in restitution and a $25,000 fine for crimes involving the attack on PowerSchool and an undisclosed U.S. telecommunications company.”

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports,
    • “Federal cyber authorities issued an emergency directive Wednesday [October 15] requiring federal agencies to identify and apply security updates to F5 devices after the cybersecurity vendor said a nation-state attacker had long-term, persistent access to its systems.
    • The order, which mandates federal civilian executive branch agencies take action by Oct. 22, marked the second emergency directive issued by the Cybersecurity and Infrastructure Security Agency in three weeks. CISA issued both of the emergency directives months after impacted vendors were first made aware of attacks on their internal systems or products.
    • F5 said it first learned of unauthorized access to its systems Aug. 9, resulting in data theft including segments of BIG-IP source code and details on vulnerabilities the company was addressing internally at the time. CISA declined to say when F5 first alerted the agency to the intrusion.
    • CISA officials said they’re not currently aware of any federal agencies that have been compromised, but similar to the emergency directive issued following an attack spree involving zero-day vulnerabilities affecting Cisco firewalls, they expect the response and mitigation efforts to provide a better understanding of the scope of any potential compromise in federal networks.
  • and
    • “F5, a company that specializes in application security and delivery technology, disclosed Wednesday that it had been the target of what it’s calling a “highly sophisticated” cyberattack, which it attributes to a nation-state actor. The announcement follows authorization from the U.S. Department of Justice, which allowed F5 to delay public disclosure of the breach under Item 1.05(c) of Form 8-K due to ongoing law enforcement considerations.
    • “According to an 8-K form filed with the Securities and Exchange Commission, the company first became aware of unauthorized access Aug. 9 and initiated standard incident response measures, including enlisting external cybersecurity consultants. In September, the Department of Justice permitted F5 to withhold public disclosure of the breach, which the government allows if a breach is determined to be a “a substantial risk to national security or public safety.”  
    • “Investigators discovered that the threat actor maintained prolonged access to parts of F5’s infrastructure. Systems affected included the BIG-IP product development environment and the company’s engineering knowledge management platform. The unauthorized access resulted in the exfiltration of files, some of which contained segments of BIG-IP source code and details regarding vulnerabilities that the company was actively addressing at the time. It also said the files taken were “configuration or implementation information for a small percentage of customers.”
  • Cybersecurity Dive adds,
    • “More than 600,000 F5 network security devices running the company’s flagship BIG-IP software are sitting unpatched on the internet one day after the company revealed that nation-state hackers had accessed its networks and source code.
    • “The figure, which Palo Alto Networks provided on Thursday [October 16], highlights how many organizations could be vulnerable to cyberattacks exploiting vulnerabilities that the unidentified hackers discovered while roaming through F5’s production environment and developer resources.” * * *
    • “F5, which said on Thursday that it believed it had kicked the hackers out of its networks, is working with government and private-sector cyber experts to further investigate the compromise. CISA ordered federal agencies to promptly patch their affected F5 products and disconnect the devices’ management interfaces from the internet.
    • “The potential impact of this compromise is unique due to the theft of confidential information regarding previously undisclosed vulnerabilities that F5 was actively in the process of patching,” Palo Alto Networks researchers wrote in their blog post. “This data potentially grants threat actors the capacity to exploit vulnerabilities for which no public patch currently exists, which could accelerate the creation of exploits.”
    • “F5 said there was no evidence that the hackers had compromised its source code or software production processes, despite having access to those systems and data.”
  • CISA added six known exploited vulnerabilities to its catalog this week.
    • October 14, 2025
      • CVE-2016-7836 SKYSEA Client View Improper Authentication Vulnerability
      • CVE-2025-6264 Rapid7 Velociraptor Incorrect Default Permissions Vulnerability
      • CVE-2025-24990 Microsoft Windows Untrusted Pointer Dereference Vulnerability
      • CVE-2025-47827 IGEL OS Use of a Key Past its Expiration Date Vulnerability
      • CVE-2025-59230 Microsoft Windows Improper Access Control Vulnerability
        • Security Affairs Discusses these KVEs here.
    • October 15, 2025
      • CVE-2025-54253 Adobe Experience Manager Forms Code Execution Vulnerability
        • Security Week discusses this KVE here.
  • Per Cyberscoop,
    • “North Korean operatives that dupe job seekers into installing malicious code on their devices have been spotted using new malware strains and techniques, resulting in the theft of credentials or cryptocurrency and ransomware deployment, according to researchers from Cisco Talos and Google Threat Intelligence Group.
    • “Cisco Talos said it observed an attack linked to Famous Chollima that involved the use of BeaverTail and OtterCookie — separate but complementary malware strains frequently used by the North Korea-aligned threat group. Researchers said their analysis determined the extent to which BeaverTail and OtterCookie have merged and displayed new functionality in recent campaigns. 
    • “GTIG said it observed UNC5342 using EtherHiding, malicious code in the form of JavaScript payloads that turn a public blockchain into a decentralized command and control server. Researchers said UNC5342 incorporated EtherHiding into a North Korea-aligned social engineering campaign previously dubbed Contagious Interview by Palo Alto Networks. 
    • “Cisco and Google both said North Korean threat groups’ use of more specialized and evasive malware underscores the efforts the nation-state attackers are taking to achieve multiple goals while avoiding more common forms of detection.”
  • Per Dark Reading,
    • “Major password managers are being impersonated in a spate of recent phishing attacks, including LastPass, Bitwarden, and 1Password, and enterprise users should be on notice. In a three-week span, all of them have been dealing with impersonation attacks by threat actors trying to con users into handing over their master password — and with it, troves of sensitive credentials.
    • Password management vendors have long been among hackers’ favorite brands to impersonate, for good reason. Users need to have complete trust in their password managers — after all, nobody would store all of their credentials for all of their accounts in an app they didn’t have total confidence in. Phishers try to exploit that trust.
    • “Because password managers are protected by a single master password, a password reset scam — “Your password has been compromised, click here to reset it” — might engender more fear and urgency in this context than in others with lower stakes (that is, unless the user understands the basic mechanics of how their manager works — namely, that their master password would never be stored online to begin with). And of course, if attackers can get their hands on just that one master password, they can access all of a user’s online accounts, plus all of the huge corporate systems they might afford access to.
    • “Either by coincidence or reflecting a growing trend, password manager phishing attacks have been popping up even more than usual this October, cyber researchers are warning.”
  • Per Bleeping Computer,
    • “Threat actors exploited a recently patched remote code execution vulnerability (CVE-2025-20352) in Cisco networking devices to deploy a rootkit and target unprotected Linux systems.
    • “The security issue leveraged in the attacks affects the Simple Network Management Protocol (SNMP) in Cisco IOS and IOS XE and leads to RCE if the attacker has root privileges.
    • “According to cybersecurity company Trend Micro, the attacks exploited the flaw in Cisco 9400, 9300, and legacy 3750G series devices and deployed rootkits on “older Linux systems that do not have endpoint detection response solutions.”
  • and
    • “Earlier this week, Microsoft patched a vulnerability that was flagged with the “highest ever” severity rating received by an ASP.NET Core security flaw.
    • “This HTTP request smuggling bug (CVE-2025-55315) was found in the Kestrel ASP.NET Core web server, and it enables authenticated attackers to smuggle another HTTP request to hijack other users’ credentials or bypass front-end security controls.
    • “An attacker who successfully exploited this vulnerability could view sensitive information such as other user’s credentials (Confidentiality) and make changes to file contents on the target server (Integrity), and they might be able to force a crash within the server (Availability),” Microsoft said in a Tuesday advisory.”
  • Per InfoSecurity Magazine,
    • “The phishing platform “Whisper 2FA” has rapidly become one of the most active tools used in large-scale credential theft campaigns, according to new research from Barracuda.
    • “Since July 2025, the platform has been responsible for nearly one million phishing attacks targeting accounts across multiple industries, placing it just behind Tycoon and EvilProxy in the global phishing-as-a-service (PhaaS) landscape.
    • “What makes Whisper 2FA stand out is its use of AJAX, a web technology that allows real-time communication between browser and server without page reloads. This enables the phishing kit to repeatedly capture credentials and multi-factor authentication (MFA) codes until it obtains a valid token. 
    • “Unlike typical phishing kits that stop after stealing a password, Whisper 2FA continuously loops through attempts, effectively bypassing MFA protections.
    • “Attackers have been using a range of lures to deliver Whisper 2FA, mimicking brands such as DocuSign, Adobe and Microsoft 365. These phishing emails often use urgent pretexts, such as invoices or voicemail notifications, to prompt users to log in and unknowingly submit their details to attackers.”

From the ransomware front,

  • Microsoft tells us,
    • “In 80% of the cyber incidents Microsoft’s security teams investigated last year, attackers sought to steal data—a trend driven more by financial gain than intelligence gathering. According to the latest Microsoft Digital Defense Report, written with our Chief Information Security Officer Igor Tsyganskiy, over half of cyberattacks with known motives were driven by extortion or ransomware. That’s at least 52% of incidents fueled by financial gain, while attacks focused solely on espionage made up just 4%. Nation-state threats remain a serious and persistent threat, but most of the immediate attacks organizations face today come from opportunistic criminals looking to make a profit.
    • “Every day, Microsoft processes more than 100 trillion signals, blocks approximately 4.5 million new malware attempts, analyzes 38 million identity risk detections, and screens 5 billion emails for malware and phishing. Advances in automation and readily available off-the-shelf tools have enabled cybercriminals—even those with limited technical expertise—to expand their operations significantly. The use of AI has further added to this trend with cybercriminals accelerating malware development and creating more realistic synthetic content, enhancing the efficiency of activities such as phishing and ransomware attacks. As a result, opportunistic malicious actors now target everyone—big or small—making cybercrime a universal, ever-present threat that spills into our daily lives.
    • “In this environment, organizational leaders must treat cybersecurity as a core strategic priority—not just an IT issue—and build resilience into their technology and operations from the ground up. In our sixth annual Microsoft Digital Defense Report, which covers trends from July 2024 through June 2025, we highlight that legacy security measures are no longer enough; we need modern defenses leveraging AI and strong collaboration across industries and governments to keep pace with the threat. For individuals, simple steps like using strong security tools—especially phishing-resistant multifactor authentication (MFA)—makes a big difference, as MFA can block over 99% of identity-based attacks.”
  • HIPAA Journal reports,
    • “Kettering Health has provided an update on its May 20, 2025, ransomware attack. The investigation confirmed that the Interlock ransomware group first gained access to its network on April 9, 2025, and retained access until May 20, 2025, when the attack was detected and the unauthorized access was blocked. During that time, the ransomware group accessed or copied files containing patient information.
    • “Kettering Health has been providing regular updates on its progress recovering from the attack and has now completed its file review. The review confirmed that current and former patients had the following information compromised in the attack: first and last name, contact information, date of birth, Social Security number, patient identification number, medical record number, medical information, treatment information, diagnosis information, health insurance information, driver’s license/state identification number, financial account information, and/or education records.
    • “Kettering Health said it has reviewed its policies, procedures, and processes related to data security and has taken steps to prevent similar incidents in the future. Kettering Health said it is unaware of any misuse of the exposed information and has provided patients with information on how they can protect themselves against identity theft and fraud. Complimentary credit monitoring and identity theft protection services do not appear to have been offered.”
  • The Record adds,
    • “Michigan City, Indiana, has confirmed that a damaging cyber incident three weeks ago that impacted government systems was a ransomware attack.  
    • “The Indiana city located on the south shore of Lake Michigan was forced to take many systems offline on September 23 and initially called it a “network disruption.” 
    • “On Saturday [October 11], the city acknowledged it was hit with a ransomware attack “that affected a portion of the City’s data and impacted municipal employees’ online and telephone access.” * * *
    • “On Monday, the Obscura ransomware gang took credit for the attack and said they stole 450 gigabytes of data. The group claimed that the time on their ransom had expired and  that they posted all of the data that was taken during the cyberattack. Obscura emerged last month and has since named more than 15 victims.”  
  • Dark Reading points out,
    • “Harvard University confirmed that it fell victim to an attack exploiting the recently disclosed zero-day vulnerability in Oracle’s E-Business Suite (EBS) system.
    • “The critical vulnerability, tracked as CVE-2025-61882, allows an attacker without authentication to remotely access EBS instances. The flaw has been exploited by the notorious Clop ransomware gang in attacks on Oracle customers.   
    • “Harvard is aware of reports that data associated with the University has been obtained as a result of a zero-day vulnerability in the Oracle E-Business Suite system,” the University told Dark Reading. “This issue has impacted many Oracle E-Business Suite customers and is not specific to Harvard. While the investigation is ongoing, we believe that this incident impacts a limited number of parties associated with a small administrative unit.”
  • and
    • “Microsoft disrupted a Rhysida ransomware campaign that used fake Teams binaries signed with digital certificates, including many from Microsoft’s own service. 
    • “In a social media post on X, Microsoft Threat Intelligence on Wednesday said it revoked more than 200 code-signing certificates issued by Azure’s Trusted Signing service. These certificates are sometimes abused by threat actors to make malware appear as if it is legitimate, trusted software.
    • “According to the post, a cybercriminal group tracked by Microsoft as Vanilla Tempest crafted the fake Teams files to drop a backdoor known as “Oyster,” which allowed attackers to eventually deliver Rhysida ransomware in victims’ networks.
    • “Vanilla Tempest, also known as Vice Society, has a track record of targeting healthcare organizations and public schools, though it’s unclear what organizations the group was targeting with its latest campaign.”
       
  • Wiz notes,
    • “Cloud ransomware targets data and systems in cloud environments by exploiting cloud-native features and APIs rather than just encrypting local files
    • “Attackers have evolved beyond simple encryption to use sophisticated tactics like data exfiltration, deletion, and manipulation of cloud services
    • “Common attack vectors include compromised credentials, misconfigured storage, overly permissive identities, and supply chain compromises
    • “Defending against cloud ransomware requires cloud-native detection and prevention strategies with deep visibility across your entire environment.”

From the cybersecurity defenses front,

  • Cybersecurity Dive reports,
    • “Fortune 500 companies have seen the structure of their security operations teams evolve in recent years, with four of every 10 companies assigning a dedicated, deputy chief information security officer or an equivalent leadership role, according to a report released Thursday from IANS Research and Artico Search. 
    • “A deputy CISO steps in when the CISO is unavailable and is seen as the eventual successor to the CISO in the company’s risk management hierarchy, according to researchers. 
    • “In practical terms, the deputy CISO often either holds a dual role as a functional department head who takes on additional executive leadership responsibility or operates as a chief of staff who also takes on CISO-like responsibilities that the CISO needs to delegate,” Nick Kakolowski, senior research director at IANS Research told Cybersecurity Dive via email.”
  • Beckers Hospital Review calls attention to six notes about health system efforts to sharpen their cybersecurity and margins narrow.
  • Dark Reading relates,
    • “Agentic AI deployments are becoming an imperative for organizations of all sizes looking to boost productivity and streamline processes, especially as major platforms like Microsoft and Salesforce build agents into their offerings. In the rush to deploy and use these helpers, it’s important that businesses understand that there’s a shared security responsibility between vendor and customer that will be critical to the success of any agentic AI project.
    • “The stakes in ignoring security are potentially high: last month for instance, AI security vendor Noma detailed how it discovered “ForcedLeak,” a critical severity vulnerability chain in Salesforce’s agentic AI offering Agentforce, which could have allowed a threat actor to exfiltrate sensitive CRM data from a customer with improper security controls through an indirect prompt injection attack. Although Salesforce addressed the issue through updates and access control recommendations, ForcedLeak is but one example of the potential for agents to leak sensitive data, either through improper access controls, ingested secrets, or a prompt injection attack.
    • “It’s not an easy task to add agentic AI security to the mix; it’s already challenging enough to determine where responsibility and culpability lie with traditional software and cloud deployments. With something like AI, where the technology can be hastily rolled out (by both vendor and customer alike) and is constantly evolving, establishing those barriers can prove even more complex.” 
       
  • TechRadar explains “how to plan a smooth Windows 10 to Windows 11 migration – even if you missed the October 14th [support] deadline.”
  • Here is a link to Dark Reading’s CISO Corner.

Thursday Report

From Washington, DC,

  • The Wall Street Journal reports,
    • “Republicans and Democrats both see a likely path to ending the government shutdown, involving extending enhanced Affordable Care Act healthcare subsidies for a year or longer. But there are a series of reasons why no deal has emerged, even with costs set to surge for more than 20 million Americans.
    • “The shutdown is now entering its third full week, with no serious talks under way. The House passed its short-term bill to fund the government through Nov. 21 and has been out of town since. Democrats have repeatedly blocked the measure in the Senate, where Republicans have a 53-47 majority, but 60 votes are required to advance the legislation.”
  • Per a Senate news release,
    • “Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and John Hickenlooper (D-CO) introduced the 21st Century Dyslexia Act, legislation that incorporates the modern, scientific understanding of dyslexia into federal statute and prevents the harm unidentified dyslexia can inflict on young students.
    • “Despite dyslexia impacting one in five Americans, students are rarely tested,” said Dr. Cassidy. “This legislation brings a common-sense approach to dyslexia, ensuring students have the resources they need to reach their full potential.”
    • “Better early screening, more awareness, and modern tools will help make sure kids with dyslexia are diagnosed early. These resources are inexpensive and immensely valuable. I know – I lived it,” said Senator Hickenlooper.
    • “U.S. Representatives Erin Houchin (R-IN), Julia Brownley (D-CA), and Bruce Westerman (R-IN) introduced the companion legislation in the U.S. House of Representatives.” * * *
    • “Read the full bill text here.”
  • Tammy Flanagan, writing in Govexec, explains “what to know when your child ages out of federal health coverage. Children can stay on a parent’s FEHB or PSHB plan until 26, but understanding the 31-day extension, conversion options and Temporary Continuation of Coverage is key to avoiding gaps.” The FEHBlog’s advice is to move your adult child to their employer sponsored health plan which should be a snap.
  • FedWeek tells us,
    • “An inspector general report has cited some positives for USPS finances but also notes that its financial picture in recent years has benefitted from several special infusions of funding from Congress that it called “unique events.” * * *
    • “First Class mail volume “is not expected to return to levels previously seen in the early part of the 20th century,” it said, and “ultimately, future retirement obligations will need to be funded.”
    • “Eliminating the prefunding requirement temporarily alleviated the Postal Service’s financial burden but did not change the fact that once the [Postal Service Retiree Health Benefits Fund] runs out of funds, the Postal Service is responsible for funding its share of the healthcare premium costs for its retirees as the costs are incurred,” it said.”
  • Per a Labor Department news release,
    • “U.S. Secretary of Labor Lori Chavez-DeRemer today joined President Trump at the White House as the President announced the third most-favored-nation agreement, which will result in significant cost savings on fertility treatments. On the heels of the President’s announcement, the U.S. Department of Labor, joined by the Departments of Health and Human Services and Treasury, issued guidance designed to cut burdensome red tape, helping employers understand how to structure health benefits to expand access to fertility treatments like In Vitro Fertilization or IVF.” * * *
    • “Following the President’s announcement today, the Departments of Labor, Health and Human Services, and Treasury issued new guidance in line with the President’s Executive Order 14216, “Expanding Access to In Vitro Fertilization.” The guidance clarifies existing categories of excepted benefits that employers can use to offer fertility benefits, including fertility treatment through a specified disease or illness policy, or offering reimbursement for those services through an excepted benefits health reimbursement arrangement.
    • “The departments also intend to propose rulemaking aimed at providing additional ways that certain fertility benefits may be offered as a limited excepted benefit. The departments are also considering whether to modify the standards under which supplemental health insurance coverage provided by a group health plan, including a supplemental benefit for fertility coverage, will be considered to satisfy the conditions for being an excepted benefit.”
  • According to a Paragon Health Institute report,
    • “The Inflation Reduction Act caused Medicare Part D stand-alone prescription drug plan premiums to increase nearly 600 percent from 2023 to 2026.
    • “To disguise this premium spike, the Biden administration abused Medicare’s “demonstration” authority. Despite the Biden administration’s $5 billion bailout of the Inflation Reduction Act’s failed policies, the number of plans declined by over half from 2021 to 2025.
    • “The Trump administration has sensibly mitigated this abuse, phased down the bailout, and reduced distortions in the Medicare Part D program.”
  • The Postal Service Health Benefits Program relies heavily on stand-alone Medicare Part D prescription drug plan for benefit cost savings.

From the Food and Drug Administration front,

  • Per an HHS press release,
    • “The U.S. Food and Drug Administration today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.
    • “Voucher recipients will receive a decision within 1-2 months following filing of a complete application for a drug or biologic. In addition, sponsors will receive enhanced communications with review staff throughout the development process prior to their final submission and during the review period. If necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they otherwise deem appropriate.” * * *
    • “The following products were selected:
      • Pergoveris for infertility
      • Teplizumab for Type I diabetes
      • Cytisinicline for nicotine vaping addiction
      • “DB-OTO for deafness
      • Cenegermin-bkbj for blindness
      • RMC-6236 for pancreatic cancer
      • Bitopertin for porphyria
      • Ketamine for domestic manufacturing of a critical drug for general anesthesia
      • Augmentin XR for domestic manufacturing of a common antibiotic.”
  • Per MedPage Today,
    • “The FDA is warning about the potential for serious injuries with radiofrequency (RF) microneedling for skin procedures following reports of burns, scarring, disfigurement, and nerve damage.
    • “The agency said it is working with manufacturers of the class II medical devices with the hopes of identifying mitigation strategies. “While the FDA’s evaluation is ongoing, we are asking patients, caregivers, and healthcare providers to report any complications to the use of these devices for dermatologic or aesthetic skin procedures.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “The first US case of locally acquired clade 1 mpox has been reported in Long Beach, California, according to city and state health authorities.
    • “The clade 1 case is the nation’s first in a person with no recent travel history and the seventh clade 1 case in the country. The patient required hospitalization and is now isolating and recovering at home, the City of Long Beach news release said.
    • “Public health officials are reviewing the patient’s potential source of exposure and conducting contact tracing. No other cases have been identified.
    • “While the overall risk of mpox clade I exposure to the public remains low, we are taking this very seriously and ensuring our community and health care partners remain vigilant so we can prevent any more cases,” Long Beach Mayor Rex Richardson said in the release. “This underscores the importance of continued surveillance, early response, and vaccination.”
  • The New York Times reports,
    • “A study, published in the journal JAMA Ophthalmology, analyzed the number of eye injuries that brought pickleball players to hospital emergency rooms from 2005 to 2024. Dr. Tsui and his colleagues extrapolated from a database of injuries that relies on a nationally representative sample of hospitals.” * * *
    • “While there were just over 3,100 pickleball-related eye injuries that brought players to emergency rooms between 2014 and 2024, over one-third of them — some 1,262 injuries — occurred in 2024 alone.
    • “Players 50 and older, who were more likely to sustain ocular injuries than younger players, accounted for 70 percent of all eye injuries. Age-related decreases in muscle mass, bone density and balance may have made them more vulnerable, the authors said.” * * *
    • “Eye protection is not required for professional or casual play, the authors of the study noted. USA Pickleball, the sport’s governing body in the United States, last year disapproved of a rule change that would require players to wear eye protection in its tournaments, saying it would be difficult to enforce.
    • “Pickleball clubs and courts also do not require eye protection. But the American Academy of Ophthalmology last year recommended players wear eyewear that meets the American Society for Testing and Materials F3164 guidelines, which are the standard for most racket sports.”
  • United Healthcare, writing in LinkedIn, ponders whether GLP-1 drugs are real-life wonder drugs.
    • “GLP-1 drug sales are up 500% since 2018, with growth accelerating as new uses emerge.
    • “Beyond diabetes and obesity, they show promise for Alzheimer’s, cancer and more.
    • ‘GLP-1 users also saw a 44% drop in hospitalizations from stroke, heart attack and heart failure.”
  • The Genetic Engineering and Biotechnology News relates,
    • “Although it well known that the human gut contains a large and diverse array of bacteriophages, a functional understanding of the phage–host interactions is limited. This is, in part, due to a lack of cultured isolates available. Now, a new study uncovers hundreds of new phages within our gut, information that could eventually reshape the gut microbiome, potentially influencing gut health and the progression of various disease states.
    • “Published in Nature in the paper, “Isolation, engineering and ecology of temperate phages from the human gut,” the study is the first of its kind and uses a large-scale, culture-based approach to isolate and study temperate bacteriophages in the human gut.
    • “This is a foundational study that changes how we think about and study the viruses within the human gut,” said Jeremy Barr, PhD, professor at the Monash University’s School of Biological Sciences. “We found that compounds produced in human gut cells can wake up dormant viruses inside gut bacteria. This could have major implications for gut diseases like inflammatory bowel disease (IBD), where inflammation and cell death are common.”
  • Per MedPage Today,
    • “There were 176.6 major congenital malformations (MCMs) per 10,000 infants exposed to first-trimester COVID-19 mRNA vaccines, compared with 179.4 per 10,000 infants not exposed to the vaccines.
    • “There were no associations between mRNA vaccine exposure and MCMs by organ system.
    • “There was no difference in the rate of stillbirths between pregnant women who received mRNA vaccines and those who didn’t (both 0.4%).”
  • Per BioPharma Dive,
    • “A regimen pairing Johnson & Johnson’s dual-pronged multiple myeloma drug Tecvayli with an older medication, Darzalex, staved off disease progression and death better than Darzalex and a standard drug combination in a Phase 3 trial, the company said Thursday.
    • “According to J&J, a panel of independent trial monitors recommended halting the study early after the Tecvayli regimen met its objectives at an early data check. Researchers have been following trial volunteers for an average of about three years.
    • “The trial assessed the Tecvayli combination in people whose multiple myeloma had progressed after one to three prior treatment lines. Tecvayli is currently available to patients who’ve previously received at least four lines of care. That clearance, awarded in 2022, was an “accelerated” approval, which requires confirmation from a trial that demonstrates a survival benefit.”
  • and
    • “Final results from a years-long study show that Novartis’ Fabhalta medicine can significantly slow the decline of kidney function in patients with IgA nephropathy, the Swiss drugmaker said Thursday.
    • “The trial, known as Applause-IgAN, compared twice-daily doses of Fabhalta with a placebo in patients with the rare kidney disease. After two years of treatment, researchers found that the patients on Fabhalta had significantly better results on a scale that measures how well kidneys filter waste from the blood.
    • “Fabhalta had already won accelerated approval from the Food and Drug Administration in 2024 based on initial data showing the drug could reduce protein in the urine of patients with the condition. With the final study results in hand, Novartis now plans to seek a full, traditional approval of the medicine for IgAN patients next year.”
  • and
    • “In March 2023, investors could buy a share of Praxis Precision Medicines for about the same price as a dollar-menu item at a fast-food restaurant. The Boston-based biotechnology company had just suffered a major setback with one of its experimental medicines, which failed a key study testing it as a treatment for a neurological disease that causes involuntary shaking.
    • “Praxis, as drug companies often do, found enough silver linings in the data to push its medicine forward. The company consulted with the Food and Drug Administration that summer and began enrolling two late-stage trials that fall. By February 2025, a group of independent experts were telling Praxis the first of those trials looked unlikely to succeed. It decided to continue anyway.
    • “That confidence appears to have paid off, as Praxis on Thursday disclosed that both of its studies met their main goals. The company now plans to submit an approval application to the FDA by early 2026. Its share value, which got buffed in late 2023 from a 1:15 stock split, more than tripled on the announcement, peaking at $200 Thursday afternoon.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • ‘New York City-based Montefiore Health System and Garnet Health have signed a letter of intent for Garnet to join the academic health system through a strategic affiliation. 
    • “Garnet Health, a three-hospital system headquartered in Middletown, N.Y., serves more than 500,000 residents across New York’s mid-Hudson and Catskills regions.
    • “The proposed transaction would expand Montefiore’s presence in the Hudson Valley and strengthen Garnet Health’s clinical services, specialty care offerings and long-term sustainability.
    • “Montefiore, which operates 10 hospitals and more than 200 outpatient sites, described the deal as a natural fit.”
  • and
    •  “Already-strained emergency departments are not only projected to experience more volume in the near future, but also more clinical cases requiring immediate attention, according to a Vizient Sg2 report published Oct. 15.
    • “Vizient, which works with hundreds of U.S. hospitals and other healthcare providers, estimates a 5% increase in ED visits between 2025 and 2035. Urgent visits are projected to remain stagnant while emergent cases — those requiring immediate action — are expected to rise 8% over the decade. 
    • “Over the past year, emergent visits increased 6% while urgent visits stabilized. Sixty-five percent of ED visits between the third quarter of 2024 and the second quarter of 2025 were emergent. 
    • “While urgent visits have stabilized, continued efforts to redirect low-acuity patients to alternative care sites remain essential to improving ED throughput and preserving capacity for higher-acuity cases,” the report said.”
  • and
    • “Physician compensation rose more in 2025 than in any year over the past decade, largely due to clinician supply and demand imbalances, according to a survey from SullivanCotter. 
    • “Published Oct. 15, the survey is based on data from more than 500 healthcare organizations representing approximately 231,300 physicians across 232 specialties. It found that median physician total cash compensation — base salary plus incentives — grew year over year across all major specialty categories.
    • “Among those, adult medical specialties saw the largest year-over-year increase at 7.5%, as physician workforce expectations continue to evolve.”
  • Modern Healthcare discusses why private equity wants in on outpatient cardiology.
    • “Private equity investors are training their attention on cardiology — a fast-growing specialty rife with financial opportunity. 
    • “Investor interest in outpatient cardiology practices has grown in recent years, driven by a fragmented market landscape facing financial pressures and an aging population of patients and providers. The Centers for Medicare and Medicaid Services also is reimbursing more cardiac procedures in ambulatory settings, which has been an impetus for private equity firms to make investments.
    • “The growing number of transactions and operational changes hasn’t quieted skepticism about whether the investments are a win for patients. There is limited post-acquisition data on quality, patient volumes and costs of care at individual cardiology practices. The data on private equity’s overall impact on the industry paints a bleak picture.
    • “Private equity is here in cardiology. It’s not going to go away,” said Dr. Samuel Jones, director of inpatient electrophysiology at the Chattanooga Heart Institute and member of the American College of Cardiology’s Board of Trustees.”
  • Healthcare Dive points out,
    • “Prospect Medical Holdings has tentative deals to sell two of its shuttered hospitals in Pennsylvania — Chester Medical Center and Springfield Hospital — for a combined $13 million, according to documents filed to bankruptcy court last week. 
    • “Chariot Allaire Partners has offered $10 million for Crozer-Chester Medical Center, while Restorative Health Foundation and Syan Investments together have offered $3 million for Springfield Hospital.
    • “Closing the deals would allow Prospect to finally rid its hands of failed Crozer Health, following years of conflict with state regulators over its management practices and failed sales attempts. Crozer fully shuttered this spring.”

From the artificial intelligence front,

  • Healthcare Dive lets us know,
    • “Google Cloud revealed several artificial intelligence partnerships with healthcare organizations on Thursday, including for projects that summarize clinical notes and automate prior authorizations. 
    • “The partnerships come as more healthcare and life science firms are deploying AI agents, or advanced tools that can more autonomously plan and perform tasks, according to a Google Cloud survey of 605 leaders released Thursday. Forty-four percent of executives said their organizations were actively using agents, with 34% reporting they use 10 or more agents.
    • “For example, Hackensack Meridian Health built multiple AI agents using Google’s generative AI technology, including a tool that can recap patients’ medical records for doctors.
    • “The health system’s note summarization agent has helped more than 1,200 clinicians generate more than 17,000 summaries since it went live in June, according to a press release.”
  • and
    • “Microsoft is expanding its artificial intelligence-backed clinical assistant to include functionality geared towards nurses, the technology giant said Thursday. 
    • “Dragon Copilot, Microsoft’s upgraded AI assistant tool launched this spring, will be able to record nurses’ interactions with patients and help document their care, as well as access medical content or health system protocols, the company said.
    • “Microsoft collaborated with multiple health systems to build the update focused on nurses’ documentation workflow. “Physicians document very differently,” said Mary Varghese Presti, corporate vice president and chief operating officer at Microsoft Health and Life Sciences. “What we built here for nurses is not a rinse and repeat of that.” 

Midweek report

From Washington, DC

  • SHOCKER — STAT News reports,
    • “The Centers for Medicare and Medicaid Services [CMS)] is pausing Medicare payments to doctors, as negotiations tied to the government shutdown drag on. 
    • “CMS announced the pause in a notice on its website but didn’t say when it would end. It’s happening because Congress needs to reauthorize certain Medicare payment programs related to telehealth and rural providers, and that reauthorization has gotten wrapped up in the overall deal to reopen the government.
    • It’s not clear why all physician payments have been cut off rather than just the programs that need to be renewed. CMS did not immediately respond to a request for comment.
    • “An extended payment pause could eventually cause cash flow concerns for doctors, several groups representing providers told STAT — and there are fears that, in some cases, claims could be left unpaid, should the renewal of programs that have lapsed not be made retroactive. Payments for ground ambulance transport services and Federally Qualified Health Centers are also in limbo.
    • “The paused payments include those going back to Oct. 1, when the government shutdown started and several health care programs lapsed.” 
  • WHIPLASH (again from STAT News) — The Centers for Medicare and Medicaid Services said late last night that it was not pausing all Medicare payments to doctors, after a statement hours earlier had asserted that it would. Instead, the agency will only wait to process claims that are related to programs that have expired, such as some telehealth or rural services. 
  • Per the Senate press gallery,
    • “2:55 p.m. October 15 — By a vote of 51-44, the Senate did not invoke cloture on the motion to proceed to H.R. 5371, [the House passed continuing resolution] upon reconsideration.
    • “Democrats voting in favor: Cortez Masto and Fetterman.
    • “Independent voting in favor: King.
    • “Republican voting against: Paul.
    • “Senators not voting: Blackburn, Duckworth, Hagerty, Marshall and Tillis.”
  • Beckers Hospital Review offers four notes on the extension of the government shutdown into a third week.
  • Govexec adds,
    • “More than 150 lawmakers, led by Sens. Tim Kaine, D-Va., Chris Van Hollen, D-Md., and Lisa Murkowski, R-Alaska, on Wednesday demanded that the Trump administration guarantee that furloughed federal employees are granted backpay at the conclusion of the ongoing federal government shutdown, which has entered its third week.
    • “Last week, the Office of Management and Budget floated a theory that the 2019 Government Employees Fair Treatment Act, which automatically provides backpay to furloughed federal workers following appropriations lapses and was signed by President Trump during the 2018-2019 partial government shutdown, merely authorizes Congress to provide backpay after a shutdown. OMB revised its shutdown FAQ document to remove reference to the law’s guarantee, and the Internal Revenue Service revoked shutdown guidance to employees, issued just days prior, that made reference to backpay.” * * *
    • In their letter to [OMB Director Russell] Vought, the lawmakers insinuated that OMB’s stance may be more motivated by politics than a good-faith legal analysis and urged the White House to reaffirm furloughed workers’ right to backpay.
  • OPM has released a description of Federal Benefits Open Season Highlights 2026 Plan Year, which identifies the plans and plan options withdrawing from the FEHBP, the PSHBP and FEDVIP for the 2026 plan year. The as yet unreleased OPM benefit administration letter on program changes also identifies the plans with service area changes, for example.
  • The American Hospital Association News tells us,
    • “Medicare open enrollment for 2026 began Oct. 15 and runs through Dec. 7. During the annual enrollment period, Medicare-eligible individuals can check their status, choose plans or change plans during the open enrollment period, including switching from Medicare Advantage and prescription drug plans to Traditional Medicare. The Centers for Medicare & Medicaid Services projects the average monthly premium for MA plans will fall by $2.40 in 2026 to $14.00, while the average standalone monthly total premium for a Medicare Part D prescription drug plan will fall by $3.81 to $34.50. Among other changes this year, out-of-pocket costs for prescription drugs will be capped at $2,100.”
  • CMS reminds us,
    • “Medicare’s Open Enrollment Period is here! Visit Medicare.gov/plan-compare now through December 7 to compare all your coverage options. 
    • “Even if you’re happy with your current plan, it’s important to check for any changes next year. You can also check the star ratings to compare the quality of different health and drug plans.”
  • The Wall Street Journal alerts us that “Big changes Are coming for 2026 Medicare Plans. What You Need to Know. Skinnier benefits, higher premiums and fewer options mean more than a million seniors should shop for new coverage during open enrollment.”
  • Healthcare Dive reports,
    • “CMS Administrator Dr. Mehmet Oz highlighted areas where Medicare Advantage could improve — while reaffirming his support for the privatized Medicare program — during an event organized by the top MA lobby on Wednesday.
    • “Oz’s comments reflect the difficult tightrope regulators in the Trump administration walk as they pursue MA reform, especially in the areas of improper overpayments and prior authorizations, without offending the powerful insurance industry.
    • “I came both to celebrate what you’re trying to do, but also be honest about some of the issues that we’re seeing at CMS,” Oz said during the Better Medicare Alliance’s forum in Washington, D.C. “The opportunities we have if we do this correctly are massive. I see Medicare Advantage as this essential lever arm, this tool that we can use for good — and sometimes not — but if we use it correctly and nimbly, we can do all kinds of things to refine and improve the system.”
  • Medscape notes,
    • “Enrollment in Medicare Advantage was associated with an increased likelihood of receiving an Annual Wellness Visit, especially among racial and ethnic minorities, those with dual eligibility, and those with Alzheimer’s disease and related dementias.”
  • Per Fierce Healthcare,
    • “Fifteen governors unveiled Wednesday a new coalition to coordinate public health efforts in the latest sign of distrust in federal health agencies.
    • “The so-called Governors Public Health Alliance is now the largest alternative public health authority run by states, with leaders representing 129 million Americans, and follows the three-state West Coast Health Alliance and the 10-state Northeast Public Health Collaborative. The new effort is described as complementary to the states’ existing public health mechanisms and in line with the two existing coalitions.
    • “Announcements from several of the governors describe the effort as nonpartisan, though all the current participating leaders are Democrats. The alliance itself is supported by GovAct, a nonprofit and nonpartisan platform for gubernatorial collaborations.
    • “Similar to other states’ efforts, the governors said their new alliance will share best practices and expertise, coordinate on disease surveillance, co-draft public health guidelines and purchase supplies such as vaccines. It will also keep an open dialogue with the global health community while “elevating national considerations for vaccine procurement, policy solutions and more,” according to announcements.”

From the judicial front,

  • The Wall Street Journal relates,
    • “A federal judge temporarily blocked the Trump administration from moving ahead with mass firings of federal employees while the government is shut down. 
    • “Judge Susan Illston issued the temporary restraining order in a ruling from the bench on Wednesday, stopping the government from cutting federal workers at multiple agencies. 
    • “The court record suggested that the Trump administration has “taken advantage of the lapse in government spending and government functioning to assume that all bets are off, that the laws don’t apply to them anymore and that they can impose the structures that they like on the government situation that they don’t like,” said Illston, a Bill Clinton appointee. 
    • “The Trump administration moved ahead on threats last week to lay off federal workers, sending reductions in force notices, otherwise known as RIFs, to about 4,000 employees at more than a half-dozen federal agencies, including the departments of Treasury, Health and Human Services, Education and Commerce.”
  • Healthcare Dive informs us,
    • “A federal judge has thrown out a last-ditch effort from Humana to get the government to recalculate its Medicare Advantage star ratings for 2025.
    • “On Tuesday, Judge Reed O’Connor of the Texas Northern District Court ruled that the CMS acted legally in downgrading Humana’s stars based on unsuccessful customer service calls.
    • “O’Connor dismissed the case with prejudice, meaning it can’t be refiled but could still be appealed. A spokesperson for Humana said the company is “disappointed” with the ruling and is considering “all available legal options.”
  • Sequoia explains how to navigate the legal landscape of gender-affirming care in employer health plans.

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP points out,
    • “A new update from the South Carolina Department of Health (SCDH) says the state’s measles outbreak has grown by 5 cases, to 16 infections since July, including 12 cases that are part of an Upstate outbreak that has seen two schools send hundreds of unvaccinated kids home after exposure to the highly contagious virus.
    • “The cases come as the US total climbs to 1,596 confirmed infections.”
  • Medscape discusses a new COVID variant known as Frankenstein.
    • “According to the World Health Organization (WHO), this rise is associated with the emergence of a new SARS-CoV-2 variant, XFG, also referred to as “Frankenstein,” because it is a recombinant of two other variants, LF.7 and LP.8.1.2.
    • “XFG has been classified by the WHO as a variant under monitoring since 25 June 2025 and is growing globally. Current evidence suggests that the additional public health risk is low worldwide, and approved COVID vaccines are expected to remain effective against this variant to prevent symptomatic and severe disease.”
  • The Washington Post lets us know,
    • “Health officials in New York state confirmed the first locally acquired case of chikungunya in the United States in six years. The virus is rarely fatal, and most patients recover in a week, but in some cases, it can cause prolonged and debilitating joint pain.
    • “It is also the first locally acquired case of chikungunya in New York, the state’s health department said. A resident of Nassau County, who was not named, had not reported any foreign travel before experiencing symptoms in early August, the county’s health department said. County officials said on Tuesday they had not found chikungunya in local mosquitoes, adding: “There is no evidence of ongoing transmission of the virus and the risk to the general public remains low.”
  • Per Healio,
    • “Alcohol-induced deaths increased by 89% from 1999 to 2024, peaking in 2021.
    • “These deaths rose by 255% among women aged 25 to 34 years and by 188% among men aged 25 to 34 years.”
  • and
    • “Mean BMI increased for premenopausal women and postmenopausal women in the U.S. from 1999 to 2018.
    • “The 50th percentile BMI for premenopausal and postmenopausal women peaked at about age 60 years.”
  • Per Medscape,
    • “Egg- and non-egg-based influenza vaccines showed equivalent protection against laboratory-confirmed influenza‑like illness and related hospitalizations among healthy adults in the military health system. However, recombinant influenza vaccine achieved higher seroconversion rates across all influenza subtypes.”
  • and
    • “Penicillin V was as effective as amoxicillin for treating pneumonia in primary care, with similar rates of hospitalization for lower respiratory tract infection or all-cause mortality within 28 days of starting antibiotic therapy, making it a viable alternative in primary care settings with similar resistance patterns.”
  • Per Fierce Pharma,
    • “GSK’s ViiV Healthcare and its bimonthly pre-exposure prophylaxis (PrEP) medicine Apretude had to make room for another long-acting PrEP option this summer, when rival Gilead Sciences rolled out Yeztugo to much fanfare.
    • “But despite Yeztugo’s twice-yearly convenience factor, unprecedented efficacy performance in trials and award-winning pedigree, GSK has long maintained that one aspect of the rival drug’s clinical profile would block it from snatching the entire long-acting PrEP market.
    • “Now, armed with a new open-label crossover study, the company can back up its theory that the injection-site reactions from Gilead’s drug may give some potential users pause.
  • Per BioPharma Dive,
    • “Eli Lilly released the results of two new Phase 3 trials of an experimental GLP-1 pill that the company says could become a “foundational treatment” for type 2 diabetes.
    • “The medicine, orforglipron, succeeded on all primary and key secondary endpoints in the studies of diabetes patients, Lilly said Wednesday. One trial, Achieve-2, compared orforglipron with dapagliflozin, sold by AstraZeneca as Farxiga. The other, Achieve-5, tested orforglipron against a placebo in patients also taking insulin.
    • “The Indianapolis-based drugmaker plans to submit global regulatory applications for orforglipron in the treatment of type 2 diabetes next year. The company said it will seek approval of the drug as an obesity medication by the end of 2025.”
  • Beckers Hospital Review identifies “six new drug shortages and discontinuations, according to drug supply databases from the FDA and American Society of Health-System Pharmacists.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit Health and the University of Pittsburgh Medical Center have signed a non-binding letter of intent to integrate Steubenville, Ohio-based Trinity Health System into UPMC. 
    • “CommonSpirit and Trinity Health leaders began a search earlier this year to find a regional health system that would add to Trinity’s offerings, according to a Wednesday news release.
    • “The health systems will work toward a definitive agreement over the next several months.” 
       
  • Healthcare Dive informs us,
    • “CVS has completed a deal to buy 63 Rite Aid and Bartell Drugs stores in Idaho, Oregon and Washington. As part of the deal, which comes five months after Rite Aid filed for bankruptcy, CVS will also acquire the customer prescription files of 626 locations across 15 states.
    • “The agreement was first announced in May, though CVS at that time planned to acquire 64 locations and 625 prescription files. The transfer of assets was approved by a bankruptcy judge later that month.
    • “CVS is also bringing on more than 3,500 employees from the defunct chain and has made “targeted investments” in existing CVS locations to meet the needs of new shoppers. That includes adding more support and improving training programs for associates.”
  • The New York Times reports,
    • “For years, Democrats and Republicans have sounded the alarm about America’s dependence on China for medicines. An analysispublished on Wednesday shows just how deep that reliance is at the earliest stage of the drug manufacturing process: Nearly 700 U.S. medicines use at least one chemical solely sourced from China.
    • “As tensions between Washington and Beijing have escalated in recent years, experts fear that this reliance could leave American patients vulnerable, especially if a trade war or future pandemic prompts China to curtail exports. Supply shortages for some generic medicines have already grown common.
    • “The new data, from U.S. Pharmacopeia, a nonprofit that tracks the drug supply, identified the origins of chemicals used to make medicines. The analysis found that China was the sole supplier of at least one chemical in widely used antibiotics, like amoxicillin, and generic drugs for heart problems, seizures, cancer and H.I.V.
    • “One example is the allergy-relief medicine best known by the brand name Benadryl. (Kenvue, the company that sells Benadryl, did not return a request for comment.)
    • “There is almost no production of these chemicals in the United States because making them is dirty and labor and other costs make manufacturing them unprofitable. Chinese factories, by contrast, don’t face the same environmental restrictions and can make these raw materials inexpensively.”
  • Fierce Healthcare notes,
    • “Blue Cross Blue Shield Global Solutions is teaming with Carrot to offer family planning and fertility services to expatriate members across the world.
    • “BCBS Global Solutions, jointly owned by 15 Blue Cross plans and Bupa Global, will connect members globally with Carrot’s array of hormonal and family planning care, ranging from fertility, pregnancy, postpartum, surrogacy, adoption, menopause and low testosterone management. The organization shared the announcement exclusively with Fierce Healthcare.
    • “Through Carrot’s platform, members can access a network of more than 17,000 vetted providers worldwide, plus services that are available in more than 25 languages or through live translation across 300 languages.
    • “Following our recent rebrand, this partnership with Carrot marks another step forward in our commitment to deliver innovative global healthcare solutions,” said Simon Jackson, Chief Growth Officer of BCBS Global Solutions, in the announcement.”
  • Per Fierce Pharma,
    • “With sales of potential blockbuster Lokelma scaling up, AstraZeneca is bolstering its production of the hyperkalemia treatment with a $445 million injection of funds.
    • “The investment will increase the capabilities of AZ’s manufacturing facility in Coppell, Texas, which is the company’s lone site in the world that produces Lokelma.
    • ‘AZ will build a new 9,000-square-foot building at the complex and add two production lines, doubling its capacity to manufacture the treatment. The investment also will support upgrades for drug substance production and lab testing, as well as additional warehouse and administrative space, the company said in an Oct. 15 release.”

From the artificial intelligence front,

  • Fierce Healthcare offers a look inside Elevance Health’s AI strategy.
    • “The pace of digital innovation in healthcare is rapidly accelerating, and, for the team at Elevance Health, a simple mantra remains at the heart of its efforts: Keep the member at the center.
    • “Ratnakar Lavu, executive vice president and chief digital information officer at Elevance, told Fierce Healthcare in an interview that the perspective is born from his experience in consumer industries like retail, where many patients form their expectations for digital experiences.
    • “Digital platforms can make things simpler and more personalized for members, he said, but there’s also a risk of deploying new tech just for the sake of it.
    • “My obsession always has been, let’s focus on the consumer, the member, and in our case, the patient, and keep them at the center of how we think about overall transformation,” he said. “Because it’s not technology for the sake of technology, it is really trying to focus on the experiences that we want to bring to life.”
  • STAT News reports,
    • Lyra launches ‘clinical grade’ chatbot amid growing concern about mental health and AI
    • The company is the largest to launch a generative AI product as a part of ongoing therapy treatment.”
  • and
    • “As more nurses deliver primary care, an AI startup wants to guide their decisions and training> Altitude has raised $5.4 million to develop its platform and expand customer base.
  • MedTech Dive shares “five AI takeaways from AdvaMed’s conference. Medical device firms discussed privacy, regulations and prioritizing projects as AI becomes more prevalent in the industry.

Cybersecurity Saturday

From the cybersecurity policy and law enforcement front.

  • Cyberscoop tells us,
    • “A top Senate Democrat introduced legislation Thursday to extend and rename an expired information-sharing law, and make it retroactive to cover the lapse that began Oct. 1.
    • “Michigan Sen. Gary Peters, the ranking member of the Homeland Security and Governmental Affairs Committee, introduced the Protecting America from Cyber Threats (PACT) Act, to replace the expired Cybersecurity and Information Sharing Act of 2015 (CISA 2015) that has provided liability protections for organizations that share cyber threat data with each other and the federal government. Industry groups and cyber professionals have called those protections vital, sometimes describing the 2015 law as the most successful cyber legislation ever passed.
    • “The 2015 law shares an acronym with the Cybersecurity and Infrastructure Security Agency, which some Republicans — including the chairman of Peters’ panel, Rand Paul of Kentucky — have accused of engaging in social media censorship. As CISA 2015 has lapsed and Peters has tried to renew it, “some people think that’s a reauthorization of the agency,” Peters told reporters Thursday in explaining the new bill name.” * * *
    • “Michael Daniel, leader of the Cyber Threat Alliance made up of cybersecurity companies, told CyberScoop that his organization hasn’t been affected by the lapse yet, but that’s partially because it’s an organization that was set up with the long term in mind, with a formalized structure that included information-sharing requirements for members.
    • “The lapse might also not immediately affect other organizations, he said, comparing it to the risks of the government shutdown underway.
    • “An hour-long lapse doesn’t really do very much, but the longer it goes on, the more you have time for organizations to say, ‘Well, maybe we need to reconsider what we’re doing, maybe we need to think about it differently,’” Daniel said. “The longer it goes on, you start having questions about, ‘Maybe this thing won’t get reauthorized down the road.’ And once you start questioning the long-term prospects, that’s when people start making changes in their behavior.”
  • The American Hospital Association News (“AHA”) informs us,
    • “The Health Sector Coordinating Council Oct. 7 released its Sector Mapping and Risk Toolkit, created to help health care providers and other organizations visualize key services that support essential health care workflows and determine which of them present critical risk of cyberattack disruption capable of impacting care delivery, operations and liquidity. The toolkit consists of 17 health care workflow maps and usage guidelines and encourages organizations to prioritize their risks, mitigate them where possible and develop recovery and continuity plans that cannot be controlled or mitigated.
    • “The SMART initiative was created in April 2024 as a response to the cyberattack on Change Healthcare two months earlier. The AHA contributed the development of this project, which has helped identify these systemically important, mission-critical services for health care.”
  • AHA President and CEO Rick Pollack writes in the AHA News about his thoughts on this Cybersecurity Awareness Month.
    • “This week, the FBI issued an urgent warning to all users — including hospitals — of a critical security soft spot within Oracle’s E-Business Suite, stating “This is ‘stop-what-you’re-doing and patch immediately vulnerability.’”
    • “The vulnerability has allowed cyber bad actors to carry out data theft ransomware attacks. Oracle is offering a patch to address the security problem.
    • “This latest threat reminds us that cybercrime is ever-present, and health care has been the No. 1 target for years. Hospitals and health systems are committed to taking every possible precaution to protect system operability and patients’ personal data, and the good news is their defenses block most attacks.
    • “But no individual hospital can defend against all of these very sophisticated criminal and nation-state sponsored attacks. That’s why we need a whole-of-government approach to preventing and mitigating cyberattacks, including the federal government going after the bad guys as it has effectively done in counterterrorism.
    • “As we observe Cybersecurity Awareness Month this October, we must remain aware that the scope, frequency and sophistication of cyber incursions into health care have increased steadily. The evolving tactics used by bad actors to steal information, encrypt systems, delay and disrupt patient care, and shut down vital systems continue to put patient care and safety at risk.”
  • Dark Reading adds,
    • “Last night [October 9, 2025], the FBI, in coordination with law enforcement in France, seized the latest version of the BreachForums’ underground forum domain, which was converted earlier this month into an extortion site used by Scattered Lapsus$ Hunters, the gang behind the recent high-profile spate of Salesforce data heists.
    • Scattered Lapsus$ Hunters is an apparent combination of the Scattered Spider, Lapsus$, and ShinyHunters cybercriminal groups that first emerged this past summer. It has been busy compromising Salesforce data and claims that Salesforce victims have up until midnight Eastern Time today, Oct. 10, to meet its ransom demands before it will start publishing the stolen records. 
    • “Despite the BreachForums site being taken down, the group’s Tor Dark Web site is still accessible, and will be used to leak the data, the threat actors claimed.
    • “Aside from Salesforce data, Scattered Lapsus$ Hunters claims to have 1 billion records and 39 victim organizations listed on the site with sample data, such as Chanel, Disney and Hulu, Marriot, Google, Toyota, FedEx, and many more.
    • “For its part, Salesforce has issued its own statement, acknowledging the extortion attempts and reiterating that there is no indication that the Salesforce platform itself had been compromised.”

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports,
    • “A brute-force attack exposed firewall configuration files of every SonicWall customer who used the company’s cloud backup service, the besieged vendor said Wednesday.
    • “An investigation aided by Mandiant confirmed the totality of compromise that occurred when unidentified attackers hit a customer-facing system of SonicWall controls. The company previously said less than 5% of its firewall install base stored backup firewall configuration files in the cloud-based service.
    • “SonicWall did not answer questions about the extent to which the investigation revealed a more widespread impact for its customers, or if its assessment of that 5% figure remained accurate. The company initially revised its disclosure to clarify the scope of exposure was less than 5% of firewalls as of Sept. 17 but has since removed that detail from the blog post. 
    • “The investigation confirmed that an unauthorized party accessed firewall configuration backup files for all customers who have used SonicWall’s cloud backup service,” the company said in a statement.” * * *
    • “Fourteen defects affecting the vendor’s products have been added to the Cybersecurity and Infrastructure Security Agency’s known exploited vulnerabilities (KEV) catalog since late 2021. Nine of those defects are known to be used in ransomware campaigns, according to CISA, including a wave of about 40 Akira ransomware attacks between mid-July and early August.
    • “While those attacks were linked to exploited vulnerabilities in SonicWall devices, the latest attack marked a direct hit on SonicWall’s internal infrastructure and practices.”
  • Security Week tells us,
    • Law firm Williams & Connolly said state-sponsored hackers breached some of its systems and gained access to attorney email accounts.
    • “The prominent Washington, DC-based law firm is known for representing political figures and government officials, including Barack Obama and the Clintons, as well as major companies such as Intel, Samsung, Google, Disney, and Bank of America. 
    • “According to a statement issued by the company, an investigation conducted with the assistance of CrowdStrike showed that the hackers exploited an unspecified zero-day vulnerability to gain access to a “small number” of attorneys’ email accounts. 
    • “The probe showed that the attack was likely the work of a state-sponsored hacker group known to have recently targeted law firms and other companies. 
    • “Williams & Connolly said there was no evidence that confidential client data was stolen or that other parts of its IT system had been compromised. 
    • “While the company’s statement does not mention China, The New York Times learned that Chinese hackers targeted Williams & Connolly, along with other law firms.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added nine known exploited vulnerabilities to its catalog this week.
  • Per Bleeping Computer,
    • “Threat actors are exploiting a zero-day vulnerability (CVE-2025-11371) in Gladinet CentreStack and Triofox products, which allows a local attacker to access system files without authentication.
    • “At least three companies have been targeted so far. Although a patch is not yet available, customers can apply mitigations.
    • “CentreStack and Triofox are Gladinet’s business solutions for file sharing and remote access that allow using a company’s own storage as a cloud. According to the vendor, CentreStack “is used by thousands of businesses from over 49 countries.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has announced another new recall for Johnson & Johnson MedTech’s Automated Impella Controller (AIC) due to a significant cybersecurity risk. 
    • “If the identified cybersecurity vulnerabilities are exploited, it may affect the essential performance of the AIC,” according to the FDA’s advisory.
    • “At this time, no cyberattacks have been tied to this specific issue. This is the fourth time in three months the FDA has shared serious safety concerns related to these devices, which serve as the primary user control interface for Impella catheters.” 
  • Per Cybersecurity Dive,
    • “AI isn’t yet transforming how hackers launch phishing attacks, although it is helping them clean up their lures, the security firm Intel 471 said in a report published on Wednesday.
    • “Several factors have combined to keep AI in an evolutionary rather than revolutionary role, the report found.
    • “Still, business and government leaders need to pay attention to several increasingly common AI-assisted attack strategies.”

From the ransomware front,

  • Sophos shares its 2025 report on the state of ransomware in healthcare.
    • “Sophos’ latest annual study explores the real-world ransomware experiences of 292 healthcare providers hit by ransomware in the past year. The report examines how the causes and consequences of these attacks have evolved over time. This year’s edition also sheds new light on previously unexplored areas, including the organizational factors that left providers exposed and the human toll ransomware takes on retail IT and cybersecurity teams.”
  • TRM Labs point out “Nine Emerging Groups Shaping the Ransomware Landscape.”
    • “Artificial intelligence (AI) has lowered the barrier to entry for cybercriminals, allowing ransomware threat actors to automate coding, generate polymorphic malware — which alters its code with each infection to evade detection — and create more convincing social engineering lures. As a result, new groups are emerging rapidly, and established groups are scaling their operations. 
    • “In this post, we take a closer look at nine emerging ransomware groups and examine how their off-chain and on-chain tactics are reshaping the ecosystem.”
  • The Hacker News relates,
    • “Three prominent ransomware groups DragonForceLockBit, and Qilin have announced a new strategic ransomware alliance, once underscoring continued shifts in the cyber threat landscape.
    • “The coalition is seen as an attempt on the part of the financially motivated threat actors to conduct more effective ransomware attacks, ReliaQuest said in a report shared with The Hacker News.
    • “Announced shortly after LockBit’s return, the collaboration is expected to facilitate the sharing of techniques, resources, and infrastructure, strengthening each group’s operational capabilities,” the company noted in its ransomware report for Q3 2025.
    • “This alliance could help restore LockBit’s reputation among affiliates following last year’s takedown, potentially triggering a surge in attacks on critical infrastructure and expanding the threat to sectors previously considered low risk.”
  • Per Cyberscoop,
    • “Microsoft Threat Intelligence said a cybercriminal group it tracks as Storm-1175 has exploited a maximum-severity vulnerability in GoAnywhere MFT to initiate multi-stage attacks including ransomware. Researchers observed the malicious activity Sept. 11, Microsoft said in a blog post Monday.
    • “Microsoft’s research adds another substantive chunk of evidence to a growing collection of intelligence confirming the defect in Fortra’s file-transfer service was exploited as a zero-day before the company disclosed and patched CVE-2025-10035 on Sept. 18.
    • ‘Despite this mounting pile of evidence, Fortra has yet to confirm the vulnerability is under active exploitation. The company has not answered questions or provided additional information since it updated its security advisory Sept. 18 to include indicators of compromise. 
    • “Storm-1175, a financially motivated cybercrime group known for exploiting public vulnerabilities to gain access and deploy Medusa ransomware, exploited CVE-2025-10035 to achieve remote code execution, according to Microsoft.”
  • Per Dark Reading,
    • “A China-based threat group known as Storm-2603 has added a new weapon to its hacking arsenal.
    • “Cisco Talos researchers observed Storm-2603 abusing Velociraptor, an open-source digital forensics and incident response (DFIR) tool, in a recent ransomware attack. The open-source project, which was acquired by Rapid7 in 2021, was designed by security researcher Michael Cohen to assist incident response teams with endpoint monitoring and investigations. However, it seems attackers have turned the tables on defenders and are now leveraging Velociraptor to conceal their malicious activity.”
    • “Storm-2603 initially burst on to the threat landscape in July as one of several threat groups exploiting a set of SharePoint vulnerabilities in an attack chain known as “ToolShell.” There, the threat actors gained access to SharePoint servers, moved laterally in the victims’ networks, and deployed Warlock ransomware. In a blog post published Thursday, Cisco Talos researchers said they responded to a different incident in August, in which threat actors dropped three different types of ransomware on the victim’s VMware ESXi servers — Warlock, LockBit, and Babuk — and caused severe disruption to the organization.
    • “In addition to the ransomware trio, Cisco Talos found Storm-2603 actors had also deployed Velociraptor to aid their attack. It was a shift in strategy; the researchers noted that the tool had not been definitively tied to ransomware attacks prior to August.”
  • and
    • “Chaos ransomware has gotten a significant facelift with an “aggressive” new variant that adds destructive tactics and clipboard hijacking for cryptocurrency theft, as well as other capabilities to bolster its operations for speed and effectiveness.
    • “Researchers from FortiGuard Labs have identified a new version of Chaos ransomware written in C++, the first not written in .NET, they revealed in a report published Wednesday. This evolution also introduces a host of new features that make the ransomware harder to disrupt once it’s in execution, as well as more destructive than previous versions.
    • “This evolution underscores Chaos’s shift toward more aggressive methods, amplifying both its operational impact and the financial risk it poses to victims,” FortiGuard researcher Yen-Ting Lee wrote in the report.”

From the cybersecurity defenses front,

  • Cybersecurity Dive reports,
    • “Managing cyber risk has become a point of emphasis in the insurance and asset management sector, with companies boosting annual expenditures and increasing oversight at the board level, according to a report released Wednesday by Moody’s.
    • “Almost seven of every 10 companies have a chief information security officer overseeing corporate cyber risk, while another 10% of companies have a chief information officer overseeing cybersecurity. 
    • “More than 95% of organizations have their CISOs provide briefings directly to the chief executive officer at least on a semiannual basis. This compared with 88% using that practice in 2023.
    • “In addition, seven of 10 companies have their CISO brief the corporate board of directors, at least on a semiannual basis. This compares with 54% in 2023. Four of every 10 companies link CEO compensation to the company’s cybersecurity performance, a sharp increase from just 24% in 2023.” 
  • The Wall Street Journal adds,
    • “Security chiefs are emerging as sought-after advisers as companies plunge headlong into artificial intelligence.
    • “Although the rising threat of cyberattacks has elevated the role of chief information security officers in recent years, some say they are appearing more frequently before their boards and senior executives to help unpack the risks associated with AI.
    • “Often jokingly referred to as the “Department of No” inside companies, security staff are now being actively consulted on AI implementations. This includes explaining risks to management and collaborating with other parts of the business that haven’t typically worked closely with cybersecurity.
    • “Security was always thought of as the boat anchor; what I want is to be the boat motor,” said Pablo De La Rosa, vice president of information security at electric vehicle infrastructure specialist Vontier.”
  • Dark Reading discusses the cyber-risks associated with AI note takers. “Transcription applications are joining your online meetings. Here’s how to create policies for ensuring compliance and security of your information.”
  • Security Week notes,
    • “Google has several projects focusing on the use of AI for the discovery of vulnerabilities in software. The tech giant recently reported that its Big Sleep agent discovered a critical SQLite vulnerability and thwarted efforts to exploit it in the wild.
    • “Its latest product is CodeMender, an AI agent that not only finds security holes but also patches them. The company argues that such tools are needed because as AI gets better at discovering flaws, it will be difficult for humans to keep up with patching.” 
  • Here is a link to Dark Reading’s CISO Corner.

Tuesday report

From Washington, DC,

  • Federal News Network tells us,
    • “The guarantee of back pay for furloughed federal employees is now in limbo, as the White House weighs a different interpretation of the 2019 law that ensures federal employees get compensated following a government shutdown.
    • “A new draft legal opinion from the Office of Management and Budget, as first reported by Axios, argues that whatever funding legislation Congress ultimately passes to end the current shutdown must explicitly include appropriations to provide back pay for furloughed federal employees. And if it’s not expressly written in the spending legislation, the OMB memo argues that furloughed workers cannot receive any retroactive compensation.
    • “A copy of the OMB document, which a senior White House official shared with Federal News Network, appears to contradict OMB’s previous interpretation of the Government Employee Fair Treatment Act, or GEFTA, which President Donald Trump signed into law in 2019 during the last government shutdown. Both OMB and the Office of Personnel Management previously affirmed that under GEFTA, excepted and furloughed employees would be given back pay as soon as possible, once any current or future shutdown ends.”
  • In the FEHBlog’s opinion, this draft OMB opinion is a lead balloon.
  • Healthcare Dive shares six takeaways from CMS Administrator Mehmet Oz’s appearance on Monday before a Washington D.C. think tank audience.
  • Modern Healthcare reports,
    • “Federal regulators say they have made inroads into speeding up the process to resolve out-of-network billing disputes. It’s not enough for frustrated providers and health insurance companies.
    • “The No Surprises Act’s Independent Dispute Resolution, or IDR, process has been a punching bag for both camps since it launched in 2022, and a backlog of cases had piled up by the beginning of this year.
    • “But the share of IDR cases unsettled after 30 business days fell from 69% in January to 34% in July, the most recent month for which data are available, according to the Health and Human Services, Labor and Treasury departments. Likewise, 96.5% of disputes submitted since 2022 are either resolved or are less than 30 business days old, the departments wrote in a notice published Sept. 19.
    • “The departments’ efforts have delivered remarkable improvements in the throughput of cases compared to prior years,” the notice says. “IDR entities are now resolving disputes faster than they are submitted.”
  • STAT News informs us,
    • “The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal.
    • “Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations.”
    • “They have to now,” said one lobbyist of their clients’ thinking, noting the “anger”with Pfizer for effectively adding to their pressure to come to an agreement with the administration.
    • “The people cautioned that negotiations remain unfinished and several variables, including the government shutdown, could delay any announcements.
    • “The growing chatter around potential announcements signals the Trump administration’s pressure campaign may be paying off. But whether the deals will actually accomplish the administration’s objective — lowering prescription drug prices — remains unknown.”
  • Fierce Healthcare points out,
    • “The current state of the Medicare Part D market is a mixed bag, with premiums declining but many payers scaling back options, according to a new analysis from KFF.
    • “The report noted that the Centers for Medicare & Medicaid Services put an emphasis on “stability” in Part D when it announced premium estimates in late September, but KFF found that the total number of stand-alone Part D plans available will decrease in 2026, marking the third straight year of shrinking plan options.
    • “Some payers are trimming down their offerings, per the report. For example, Centene is ending three drug plans offered through WellCare and Health Care Service Corporation is discontinuing one of Cigna’s three Part D plans and pulling back from certain regions.
    • “Other insurers, such as Elevance Health, are exiting the stand-alone Part D plan market entirely.
    • “For 2026, beneficiaries in each state will be able to select from between eight and 12 stand-alone Part D plans, in addition to Medicare Advantage prescription drug coverage. Across the 34 Part D plan markets, a total of 360 plans will be made available by 17 parent organizations—a decrease of 22% from 2025.”
  • “As many major insurers scale back on Medicare Advantage,” Beckers Payer Issues takes a “look at the insurers that are fully backing out.”
  • NextGov/FCW explains how OPM Director Scott Kupor plans “to attract tech talent [to federal government employment] after months of workforce cuts.”
  • Per HR Dive,
    • “The U.S. Senate confirmed Brittany Panuccio, an assistant U.S. attorney for the Justice Department in Florida, as a commissioner for the U.S. Equal Employment Opportunity Commission in a 51-47 vote Tuesday. Panuccio’s confirmation was part of an en bloc vote on several nominations.
    • “Panuccio fills the seat vacated in December by Keith Sonderling, who was named deputy labor secretary in March, and gives Republicans a majority. Her term expires July 1, 2029. 
    • “Panuccio’s confirmation restores a quorum to EEOC, which has operated with only two commissioners since January, when President Donald Trump fired Democratic commissioners Charlotte Burrows and Jocelyn Samuels before the expiration of their terms.”

From the Food and Drug Administration front,

  • Healio adds,
    • “The FDA approved Zoryve cream 0.05% for the treatment of children aged 2 to 5 years with mild to moderate atopic dermatitis, according to a press release. 
    • “Currently, there are approximately 1.8 million children aged 2 to 5 years being treated with a topical therapy for AD. Zoryve (roflumilast, Arcutis) cream 0.05% is a once-daily, next-generation phosphodiesterase-4 inhibitor that offers a nonsteroidal option for children and their caregivers.
    • “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and vice chair of the department of dermatology at University of California San Diego, said in the release. “Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reassuringly explains how to get a Covid booster vaccination under the CDC’s newly approved guidelines.
  • MedPage Today reports
    • “To prevent measles outbreaks, public health systems and clinicians should look below the 35,000-foot view of state- and county-level vaccination rates against measles, mumps, and rubella (MMR) and instead aim their focus on at-risk school districts and schools, according to a statewide analysis of Texas counties.”
  • and
    • “The pre-cooked pasta Listeria recall broadened to include pasta salads and prepared dishes at Kroger, Trader Joe’s, and more grocery stores.
    • “Some Hello Fresh meals may contain Listeria-tainted spinach, USDA’s Food Safety and Inspection Service warned.
    • Chicken corn dog products from Foster Poultry Farms also were recalled after wood was found in the batter causing at least five injuries. (NBC News)”
  • Per Healio,
    • “Changing trajectories of heart health markers during young adulthood were associated with potentially increased risk for cardiovascular disease later in life, researchers reported.
    • “In addition, individuals who maintained higher levels of CV health through young adulthood had lower risk for incident CVD vs. those whose CV health was maintained at lower levels or declined, according to data published in JAMA Network Open.”
  • and
    • “Acupuncture needling greatly improved pain-related disability in older adults with low chronic back pain compared with usual care, a randomized controlled trial demonstrated.
    • “Acupuncture may be an effective and safe pain management tool for many older adult patients,” Lynn L. DeBar, PhD, MPH, a researcher at Kaiser Permanente Center for Health Research, told Healio. “While it is unlikely to take away all the pain, this study suggests that it can decrease pain-related disability substantively.”
  • The New York Times considers that “He was expected to get Alzheimer’s 25 years ago. Why hasn’t he? Scientists are searching for the secret in [76-year-old] Doug Whitney’s biology that has protected him from dementia, hoping it could lead to ways to treat or prevent Alzheimer’s for many other people.”
  • Per Health Day,
    • “Preschoolers who regularly overeat are likely swallowing their emotions as well, a new study says.
    • “Girls who overeat as preschoolers are more likely to develop anxiety, impulsivity and hyperactivity when they grow into teenagers, researchers reported in the journal BMC Pediatrics.
    • “The results indicate that children’s eating patterns could be early signs of mental health challenges, researchers said.
    • “Occasional overeating is normal, but if a child frequently overeats, it can be a sign of emotional struggles,” senior researcher Linda Booij, a professor of psychiatry at McGill University in Quebec, Canada, said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “A research team co-led by scientists at Institute for Bioengineering of Catalonia (IBEC) and West China Hospital Sichuan University (WCHSU), working with partners in the U.K., has developed a nanoparticle technology that studies showed can reverse Alzheimer’s disease (AD) in mice. Unlike other types of nanomedicine that rely on nanoparticles as carriers for therapeutic molecules, this approach employs nanoparticles that are bioactive in their own right, and which the team refers to as “supramolecular drugs.”
    • “Instead of targeting neurons directly, the therapy restores proper function of the blood-brain barrier (BBB), the vascular gatekeeper that regulates the brain’s environment. The BBB is a cellular and physiological barrier that separates the brain from the blood flow to protect it from external dangers such as pathogens or toxins. Through their newly reported research the investigators demonstrated that targeting a specific mechanism enables undesirable “waste proteins” produced in the brain to pass through this barrier and be eliminated in the circulation. In Alzheimer’s disease, the main waste protein is amyloid-β (Aβ), the accumulation of which impairs normal neuronal function.
    • “By repairing this critical interface, the researchers observed a significant reduction in brain amyloid-β (Aβ) levels and a reversal of Alzheimer’s pathology in the animal models, with cognitive benefits lasting up to six months following treatment.
    • “Study lead Giuseppe Battaglia, PhD, ICREA research professor at IBEC, principal investigator of the Molecular Bionics Group, and colleagues reported on their findings in Signal Transduction and Targeted Therapy, in a paper titled “Rapid amyloid-β clearance and cognitive recovery through multivalent modulation of blood–brain barrier transport,” in which they stated, “This innovative therapeutic paradigm offers a promising pathway for developing effective clinical interventions, addressing vascular contributions to AD, and ultimately enhancing patient outcomes…The therapeutic trilogy achieved—amyloid clearance, barrier restoration, and sustained cognitive recovery—establishes a blueprint for precision neurovascular medicine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “It was a repeat performance for all 10 children’s hospitals named as the nation’s best in this year’s iteration of U.S. News & World Report’s ranking.
    • “The highly watched list, now in its 19th year, reviewed outcomes, practices and surveyed opinions for 198 children’s hospitals.
    • “Of these, 86 hospitals were named in some respect, whether that be a top-10 ranking for 10 different pediatric specialties and/or as one of 50 unranked facilities named as a high performer on pediatric and adolescent behavioral health.
    • “Among these, 10 children’s hospitals were named to the list’s honor roll for scoring well across multiple specialties. That unranked collection is identical to last year’s honorees.
      • “Boston Children’s Hospital
      • “Children’s Hospital Colorado, Aurora
      • “Children’s Hospital Los Angeles
      • “Children’s Hospital of Philadelphia
      • “Children’s National Hospital, Washington, D.C.
      • “Cincinnati Children’s
      • “Nationwide Children’s Hospital, Columbus, Ohio
      • “Rady Children’s Hospital, San Diego
      • “Seattle Children’s Hospital
      • “Texas Children’s Hospital, Houston”
  • and
    • “Providers are betting on artificial intelligence to ease the pain point of prior authorization, a new survey shows.
    • “Cohere Health, which provides clinical intelligence to insurers and risk-bearing providers, polled 200 clinicians and office administrators and found that 99% of clinicians report confidence in using AI to back prior authorization. Most (96%) office administrators said the same.
    • “Two-thirds of those surveyed said a completely digital prior authorization process would significantly improve their workflows. Across the board, the respondents said the process should have real-time tracking baked into the experience, allowing them to track the status of key requests.
    • “Providers are speaking loud and clear: they want and deserve a prior authorization process that is smarter, simpler and more transparent,” said Brian Covino, M.D., chief medical officer of Cohere Health, in an announcement.”
  • Healthcare Dive relates,
    • “Saint Peter’s Healthcare System and Atlantic Health abandoned plans to merge on Monday, citing impacts of the “rapidly evolving healthcare landscape nationally.”
    • “The New Jersey-based health systems first announced plans to combine in January last year and signed a definitive agreement to merge in June 2024. 
    • “The systems shared scant details about why the deal fell apart. However, in a joint statement issued Monday both Atlantic President and CEO Saad Ehtisham and Saint Peter’s President and CEO Leslie Hirsch called the deal’s end disappointing.”
  • STAT News informs us,
    • “Just a decade ago, a doctor with multiple medical licenses was an anomaly. Sometimes physicians would apply for credentials from a few states if they lived near a border and wanted the flexibility to practice on either side, since a doctor needs to be licensed where their patient is physically located. In-demand specialists might get a few more if they wanted to see patients virtually. But in the years since Covid began driving patients online, the number of physicians seeking multi-state licensure has ballooned to support the growing field of telehealth.
    • “Within that group, a STAT analysis of physician licenses shows that a small but powerful cohort of physicians is accumulating licenses in all 50 states, plus the nation’s capital and its territories. These physicians don’t max out on licenses just to practice across state lines. Often, they own the medical groups that are affiliated with nationwide telehealth companies. A doctor’s full roster of medical licenses can be leveraged for online businesses that provide specialty care, build patient funnels for pharma companies seeking to sell drugs directly to consumers, prescribe compounded meds — or sometimes, all of the above. 
    • “In 2016, just nine physicians in the U.S. held active licenses in all 50 states, according to data from the Federation of State Medical Boards. By 2024, 172 doctors had filled out their bingo card, and another 356 doctors had acquired at least 45 licenses — significantly outpacing the profession’s overall growth.”
  • As we approach Open Season, the American Diabetes Association offers “Health Insurance Aid for Diabetes. Access to medical care is key to managing your diabetes. Get more information on resources available to people living with diabetes.”

Cybersecurity Saturday

From the cybersecurity policy front,

  • Federal News Network reports,
    • “The Cybersecurity and Infrastructure Security Agency typically marks October’s awareness month with a range of public engagements and outreach campaigns. But under the ongoing government shutdown, CISA has furloughed nearly two-thirds of its staff and curtailed most public communication.
    • “CISA is not actively managing its website under the shutdown. But the agency did establish a landing webpage for cybersecurity awareness month prior to the shutdown, detailing the campaign’s theme and linking to a toolkit.
    • “CISA Director of Public Affairs Marci McCarthy said, “CISA remains fully committed to safeguarding the nation’s critical infrastructure,” as part of a statement.” * * *
    • “Chris Cummiskey, a former state chief information officer and former chief management officer at DHS, said CISA typically retains enough employees to staff the agency’s watch floor, maintain technology that monitors federal networks for cyber threats, and collaborate with cyber defenders at other federal organizations, like U.S. Cyber Command.
    • “But if a major cyber incident were to occur, CISA may not have enough staff immediately on hand to manage the event.
    • “A key concern is, do you need to start recalling people?” Cummiskey said. “You probably wouldn’t have the onsite capacity to cover a major exploit without the additional help.”
    • “In addition to the shutdown, key privacy and liability protections under the Cybersecurity Information Sharing Act of 2015 expired on Sept. 30. Those protections had been pivotal to encouraging the private companies to share cyber threat data with each other and with government agencies, including CISA.
    • “Cyber experts say companies may be more hesitant to share information about new cyber threats and vulnerabilities without the statute’s protections.”
  • Cybersecurity Dive adds,
    • “Michael Daniel, president of the Cyber Threat Alliance, an information-sharing group, predicted that some companies will “suspend some sharing activities with the government,” but he added that a lot will depend on “each company’s risk tolerance.”
    • “I think some collaboration will continue,” he said, “but likely at reduced levels and requiring more human oversight.”
    • “Ari Schwartz, managing director of cybersecurity services at the law firm Venable, said, “There will just be many more lawyers involved, and it will all go slower, particularly new sharing agreements.” Venable has advised clients on what to consider when establishing such agreements.
    • “As for companies sharing information with each other, that likely will continue for now because of a lack of near-term concern about antitrust investigations, Daniel said. But companies’ attitudes could change if the program isn’t reauthorized.”
  • The National Institute of Standards announced on September 29, 2025,
    • “As part of ongoing efforts to strengthen the protections for securing controlled unclassified information (CUI) in nonfederal systems [which includes FEHB and PSHB claims data], NIST has released the following drafts for comment:
    • SP 800-172r3 (Revision 3) fpd (final public draft)Enhanced Security Requirements for Protecting Controlled Unclassified Information, provides new enhanced security requirements that support cyber resiliency objectives, focus on protecting CUI, and are consistent with the source controls in SP 800-53r5.
    • SP 800-172Ar3 ipd (initial public draft)Assessing Enhanced Security Requirements for Controlled Unclassified Information, provides a set of assessment procedures for the enhanced security requirements. These procedures are based on the source assessment procedures in SP 800-53Ar5.” * * *
    • “A public comment period will be open from September 29 through November 14, 2025. Reviewers should submit comments on all or parts of the drafts to 800-171comments@list.nist.gov.”
  • Cybersecurity Dive tells us,
    • “Barely any U.S. defense contractors say they’re fully prepared to comply with the Department of Defense’s new cybersecurity assessment program.
    • “Only 1% of companies say they’re completely ready to be assessed through the Cybersecurity Maturity Model Certification (CMMC) program, which takes effect on Nov. 10, according to a report that the managed security provider CyberSheath published on Wednesday.
    • “The percentage of respondents expressing confidence in their readiness has dropped over the past two years.”

From the cybersecurity vulnerabilities and breaches front,

  • NextGov/FCW reports on September 29, 2025,
    • “A “widespread cybersecurity incident” at the Federal Emergency Management Agency allowed hackers to make off with employee data from both the disaster management office and U.S. Customs and Border Protection, according to a screenshot of an incident overview presentation obtained by Nextgov/FCW.
    • “The hack is also suspected to have later triggered the dismissal of two dozen Federal Emergency Management Agency technology employees announced late last month, according to internal meeting notes and a person familiar with the matter.
    • “The initial compromise began June 22, when hackers accessed Citrix virtual desktop infrastructure inside FEMA using compromised login credentials. Data was exfiltrated from Region 6 servers, the image says. That FEMA region services Arkansas, Louisiana, New Mexico, Oklahoma and Texas, as well as nearly 70 tribal nations.” * * *
    • “DHS security operations staff were notified of the breach on July 7, the screenshot adds. On July 14, the unnamed threat actor used an account with high-level access and attempted to install virtual networking software that could allow them to extract information. Initial remediation steps were taken on July 16. 
    • “On Sept. 5, additional remediation actions were taken, including changing FEMA Zscaler policies and blocking certain websites, the screenshot says. Those actions were previously reported by Nextgov/FCW.”
  • Following up on last Saturday’s post about the Cisco KVEs, Cybersecurity Dive lets us know,
    • “Nearly 50,000 Cisco firewall devices with recently disclosed vulnerabilities are connected to the internet, according to new data.
    • Statistics from the Shadowserver Foundation illustrate the extent of the world’s exposure to the three flaws in Cisco’s Adaptive Security Appliance devices and Firepower Threat Defense devices, which earned a rare emergency patching directive from the Cybersecurity and Infrastructure Security Agency (CISA) after the Sept. 25 disclosure.
    • “The United States has by far the most devices that have not been patched to block exploitation of the flaws, with Shadowserver tallying more than 19,000 vulnerable U.S. devices. The U.K. ranks second, with more than 2,700 vulnerable devices, followed by Japan, Germany and Russia. Other European countries have fewer than 1,000 vulnerable devices each.
    • “Shadowserver’s records will reveal how quickly different countries are reducing their exposure as the organization continues collecting data in the coming days and weeks.
    • “A sophisticated threat actor has been using two of the new Cisco flaws, CVE-2025-20362 and CVE-2025-20333, in a stealthy cyberattack campaign that has breached multiple federal agencies and other organizations worldwide. Both vulnerabilities involve improper validation of HTTPS requests, which could allow Cisco firewalls to accept malicious requests that bypass authentication. CVE-2025-20362 could allow hackers to access restricted VPN-related URLs, while CVE-2025-20333 could let intruders run arbitrary code as root.”
  • Cyberscoop points out,
    • “Red Hat on Thursday [October, 2, 2025] confirmed an attacker gained access to and stole data from a GitLab instance used by its consulting team, exposing some customer data. The open-source software company, a subsidiary of IBM, said the breach is contained and an investigation into the attack is underway. 
    • “Upon detection, we promptly launched a thorough investigation, removed the unauthorized party’s access, isolated the instance, and contacted the appropriate authorities,” Red Hat said in a security update. “Our investigation, which is ongoing, found that an unauthorized third party had accessed and copied some data from this instance.”
    • “Red Hat said the compromised GitLab instance contained work related to consulting engagements with some customers, including project specifications, example code snippets and internal communications about the consulting services. 
    • “This GitLab instance typically does not house sensitive personal data,” Red Hat said. “While our analysis remains ongoing, we have not identified sensitive personal data within the impacted data at this time.”
  • Dark Reading informs us,
    • “The month-long outage for luxury car maker Jaguar Land Rover appears to be at an end, with the company working through a “controlled, phased restart” of its manufacturing operations this week, following a massive cyberattack that forced the company to shut down its systems.
    • “JLR said on Sept. 2 that it had “proactively” shut down operations following a cyber incident, initially stating that customer data did not seem to be stolen, but revising that statement a week later. JLR, a subsidiary of Tata Motors, likely suffered $50 million to $70 million in lost revenue per week, with the total cost of the incident estimated at a staggering $1.7 billion to $2.4 billion.
    • “The attack, and its vast impact, should be a warning for companies, says Chris Gibson, executive director of the Forum of Incident Response and Security Teams (FIRST).
    • “The outage “highlights that even large corporations with substantial resources can be completely disrupted and that critical industries may be more vulnerable than previously thought,” he says. “This was far beyond data theft; it was a complete operational outage.”
  • Security Week adds,
    • “Japanese brewing giant Asahi Group Holdings on Monday [September 29, 2025] announced that its operations in the country have been disrupted by a cyberattack.
    • “The incident, the company said, resulted in system failures that affected orders and shipments at all its subsidiaries in the country, as well as call center operations, customer service desks included.
    • “Reuters reported that production at some of Asahi’s 30 domestic factories has been suspended due to the cyberattack.
    • “At this time, there has been no confirmed leakage of personal information or customer data to external parties,” the company said in a Monday notice.
    • “Asahi said it is investigating the attack and working on restoring the affected systems but could not provide an estimated timeline for recovery.
    • “The system failure is limited to our operations within Japan,” it said.
    • “The company has not disclosed the nature of the cyberattack it fell victim to, but the system-wide outage could indicate that file-encrypting ransomware might have been used.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Corporate executives are being targeted in an email-based extortion campaign by a threat actor claiming affiliation with the notorious Clop ransomware gang, according to security researchers from Google Threat Intelligence Group and Kroll. 
    • “The hacker claims to have data stolen from breached Oracle E-Business Suite applications and has been demanding payment from various corporate executives, according to a LinkedIn post from Austin Larsen, principal threat analyst at GTIG.
    • “While researchers have not been able to substantiate the claims of a data breach, they have confirmed important links to a financially motivated threat group tracked under the name FIN11, which has prior associations with Clop.” 
  • Cyberscoop provides us with “the email Clop attackers sent to Oracle customers. The emails, which are littered with broken English, aim to instill fear, apply pressure, threaten public exposure and seek negotiation for a ransom payment.”
  • Dark Reading adds,
    • After announcing its farewell last month, the cyber extortion group known as Scattered Lapsus$ Hunters returned on Friday with a website featuring stolen Salesforce data and a list of dozens of alleged victims.
    • Scattered Lapsus$ Hunters is an apparent combination of the Scattered Spider, Lapsus$, and ShinyHunters cybercriminal groups, which first emerged over the summer in a public Telegram channel. However, just a few weeks later, the collective published a goodbye letter on Telegram and the Dark Web marketplace BreachForums, saying the three groups, as well as other threat actors, had “decided to go dark.”
    • “But Scattered Lapsus$ Hunters burst back into the limelight this week with a Dark Web leak site devoted to the recent spate of Salesforce data thefts; one of the two distinct campaigns targeting Salesforce environments recently has been attributed to a threat group tracked by Google as UNC6040, which has claimed to be ShinyHunters in its extortion attempts.
    • “According to Google, UNC6040 actors used vishing calls to convince IT support personnel at targeted organizations to grant them access to or credentials for the organizations’ Salesforce environments. Mandiant researchers this week said the threat actors have impersonated third-party vendors in the vishing calls and had also targeted users in victim organizations with elevated access to other SaaS applications.’
  • The American Hospital Association points out,
    • “A Health-ISAC (Information Sharing and Analysis Center) bulletin released Oct. 1 warns of a recently released LockBit 5.0 ransomware variant that poses a threat to health care and other sectors. LockBit 5.0 is the latest version of the ransomware-as-a-service group that has previously attacked hospitals and other organizations in the U.S. and abroad. The notice said the new variant directly targets virtual environments and has improved and enhanced technical capabilities, evasion techniques and affiliate engagement. The variant is known to target Windows, Linux and VMware ESXi software. Health-ISAC said the new variant’s technical capabilities make it faster, more flexible for affiliates and harder for security to detect and analyze. LockBit was disrupted by authorities last year before resurfacing last month.
    • “This is a very technical bulletin, but it’s important to note that it addresses a new version of a well-known ransomware,” said Scott Gee, AHA deputy national advisor for cybersecurity and risk. “Hospitals should ensure that they have defensive measures in place and that those measures are tuned and working properly.”
  • HackRead reports on September 29,
    • “The Medusa ransomware group is claiming responsibility for a ransomware attack on Comcast Corporation, a global media and technology company best known for its broadband, television, and film businesses.
    • “According to the group’s dark web leak site, they exfiltrated 834.4 gigabytes of data and are demanding $1.2 million for interested buyers to download it. The same sum has been set as ransom for Comcast if the company wants the data deleted rather than leaked or sold.
    • “To back its claims, Medusa has posted around 20 screenshots allegedly showing internal Comcast files. The group also shared a massive file listing of 167,121 entries, suggesting access to actuarial reports, product management data, insurance modelling scripts, and claim analytics.” * * *
    • “Medusa ransomware is known for publishing file listings and partial screenshots as proof of compromise while holding back the bulk of the data to increase ransom pressure. In this case, the nature of the files points toward actuarial and financial datasets, some of which appear to involve insurance calculations, customer data processing, and claim management systems.”
  • HelpNetSecurity provides us background about and advice on how to avoid Akira ransomware.
  • Wired notes that “Google has launched a new AI-based protection in Drive for desktop that can shut down a [ransomware] attack before it spreads—but its benefits have their limits.”

From the cybersecurity defenses front,

  • Per ISACA,
    • “Cybersecurity professionals from around the world recently weighed in on some of the key findings from ISACA’s latest State of Cybersecurity survey report. Aparna Achanta, security leader, IBM (US); Simon Backwell, head of information security, Benefex (UK); Donavan Cheah, senior cybersecurity consultant, Thales (Singapore); Jenai Marinkovic, vCISO/CTO, Tiro Security, and CEO & chairman of the board, GRCIE (US); Kannammal Gopalakrishnan, cybersecurity and GRC professional (India), and Carlos Portuguez, Sr. Director BISO, Concentrix (Costa Rica)—all of whom are also members of ISACA’s Emerging Trends Working Group—reflect on how these stats show up for them in the profession.”
  • and
    • “Phishing has escalated beyond masquerading techniques. Traditional attacks depended on typos, being in a rush and not so well-disguised social engineering. But hackers today use generative AI, such as WormGPT or FraudGPT, and even deepfakes, to create perfect messages with contextual background that can effortlessly be mixed with everyday corporate messages. Cofense has noted that it receives an AI-enhanced malicious email every 42 seconds, with that pace expected to accelerate in the months to come. This hypergrowth is an indication that phishing is not an outlying issue anymore but a mainstream cyber-crime, now with AI-driven precision. 
    • “The next pivot is neuro-phishing, which can tie in the details of biometric and psycho-physiological indicators, like the EEG, micro-hesitation spikes, blink frequency, and the focus of the eyes, to see the response of the user in real-time and work a different approach. Previous and extensive studies have already established the reliability of finding recognition and stress using the EEG, when users are stimulated with phishing. This is not passive baiting anymore, but a dynamic, cognitive feedback loop, which transforms human users into interactive targets.”
    • The article offers advice on creating resilience against neuro-phishing.
  • Dark Reading adds,
    • “Email security has long dominated the enterprise security conversation — and rightfully so. It remains a key vector for phishing, credential theft, and social engineering. But in 2025, the threat landscape has shifted. Quietly yet decisively, attackers increasingly are bypassing the inbox and expanding their reach across multiple channels. 
    • “Recent data from TechMagic shows that 41% of phishing incidents now employ multichannel tactics, including SMS (smishing), voice calls (vishing), and QR codes (quishing). The trend is clear: While email still matters, adversaries are shifting to mobile-first platforms like text, iMessage, WhatsApp, and social direct messages. These attacks are harder to spot, more difficult to control, and more likely to succeed, because they target the most vulnerable point in the chain: the human behind the screen.
    • “To address this growing threat to mobile platforms, new security approaches are emerging that leverage AI-driven defenses to identify and prevent social engineering attacks in real-time. By training large language models (LLMs) to understand the content and intent behind messages, these systems can flag suspicious activity and enforce protective measures before users fall victim. Whether it’s a text message posing as IT support or impersonating a vendor, these next-generation solutions focus on stopping threats at the human layer — not just at the device.”
  • Infosecurity Magazine explains how “AI-Generated Code Used in Phishing Campaign Blocked by Microsoft.”
  • Per CISO Online,
    • “A surge in vulnerabilities and exploits leaving overloaded security teams with little recourse but to embrace risk-based approaches to patching what they can.
    • “Enterprise attack surfaces continue to expand rapidly, with more than 20,000 new vulnerabilities disclosed in the first half of 2025, straining already hard-pressed security teams.
    • “Nearly 35% (6,992) of these vulnerabilities have publicly available exploit code, according to the Global Threat Intelligence Index study by threat intel firm Flashpoint.
    • “The volume of disclosed vulnerabilities has more than tripled while the amount of exploit code has more than doubled since the end of February 2025 alone.
    • “These increases make it no longer feasible for most organizations to triage, remediate, or mitigate every vulnerability, Flashpoint argues, suggesting enterprises need to apply a risk-based patching framework. But some experts quizzed by CSO went further — arguing a complete operational overhaul of vulnerability management practices is needed.
    • The article delves into that approach.
  • Per the National Institute of Standards,
    • “The NIST National Cybersecurity Center of Excellence (NCCoE) has finalized a guide, NIST Special Publication (SP) 1334, Reducing the Cybersecurity Risks of Portable Storage Media in Operational Technology (OT) Environments, to help organizations protect their industrial control systems from cybersecurity threats when using removable media devices.
    • “Portable storage media devices, like USB flash drives, are commonly used to transfer data between computers. However, using them in OT environments and industrial control systems, such as those used in power plants or manufacturing facilities, can pose a cybersecurity risk. If a USB device is infected with malware, it can spread to the industrial control system and cause problems, such as disrupting operations or compromising safety.
    • “This NCCoE resource suggests implementing physical and technical controls to limit access to these devices and ensure they are used securely.”
  • Here is a link to Dark Readings’ CISO Corner.

Cybersecurity Saturday

From the cybersecurity policy and law enforcement front,

  • Health ISAC reminds us,
    • “Despite widespread public and private interest in reauthorizing the U.S. Cybersecurity Information Sharing Act of 2015 (“CISA 2015”)[i], we are rapidly approaching September 30th, the date when the Act is set to expire barring congressional action to extend it. With time running short, let’s assess the options still being considered and breakdown how and why reauthorization is going down to the wire.” * * *
    • “The current most likely path for a CISA 2015 reauthorization is not a simple standalone bill that is quickly passed by both chambers. Instead, the most likely path runs through a short term extension as part of a continuing resolution (“CR”) and then through the National Defense Authorization Act (“NDAA”).
    • “For those who are unfamiliar, a CR is a “temporary spending [bill] that [allows] federal government operations to continue when final appropriations have not been approved by Congress and the President. Without final appropriations or a CR, there could be a lapse in funding that results in a government shutdown.”[ii] The NDAA is an annual end of year bill that provides appropriations for the Department of Defense (“DOD”). It is generally considered to be a “must pass” piece of legislation that lawmakers attempt to add otherwise unrelated policy matters.”
  • Nextgov/FCW tells us,
    • “Greg Barbaccia, the federal chief information officer, says that the Office of Management and Budget is backing the General Services Administration’s overhaul of FedRAMP, the government’s cloud security assessment and authorization program. 
    • “GSA launched FedRAMP 20x — meant to use more automation in place of annual assessments, cut red tape and speed up authorizations — in March. It announced its phase two pilot on Wednesday.
    • “Barbaccia acknowledged the past problems with FedRAMP at a Wednesday event held by the Alliance for Digital Innovation. 
    • “I have done FedRAMP in my past life,” said Barbaccia, who previously worked at Palantir and more recently at a machine-learning enabled asset manager. “What a pain in the butt.”
    • “The FedRAMP program is planning on pursuing 10 pilot authorizations at the Moderate security level as part of the new phase of FedRAMP 20x, said FedRAMP Director Pete Waterman.”
  • Per a Cybersecurity and Infrastructure Security Agency (“CISA”) news release,
    • Today [September 23, 2025], the Cybersecurity and Infrastructure Security Agency (CISA) announced the appointment of Stephen L. Casapulla as the Executive Assistant Director for Infrastructure Security.
    • “I am pleased to have Steve expand his role on CISA’s leadership team,” said Acting Director Madhu Gottumukkala. “With his extensive experience in critical infrastructure security and working with stakeholders, he is perfectly poised to lead our efforts in securing the nation’s critical infrastructure. I look forward to working with him on this important mission.”
    • Prior to joining CISA, Casapulla served as the Director for Critical Infrastructure Cybersecurity in the Office of the National Cyber Director. He previously spent over thirteen years at CISA and its predecessor, holding a variety of senior roles. His prior federal service includes work at the Small Business Administration and at the Department of State in Iraq. He also serves as an officer in the U.S. Navy Reserve, with over twenty years of service and multiple overseas deployments.

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive reports,
    • “The Cybersecurity and Infrastructure Security Agency on Thursday [September 25, 2025,] ordered U.S. government agencies to patch multiple vulnerabilities in Cisco networking products, saying an “advanced threat actor” was using them in a “widespread” campaign.
    • “This activity presents a significant risk to victim networks,” CISA said in an emergency directive that laid out a mandatory timeline for agencies to identify, analyze and patch vulnerable devices.
    • “The hacking campaign — an extension of the sophisticated “ArcaneDoor” operation that Cisco first revealed in April 2024 — has compromised multiple federal agencies, two U.S. officials told Cybersecurity Dive. Both officials requested anonymity to discuss a sensitive and evolving investigation.”
  • Cyberscoop adds,
    • “Cisco said it began investigating attacks on multiple government agencies linked to the state-sponsored campaign in May. The vendor, which attributes the attacks to the same threat group behind an early 2024 campaign targeting Cisco devices it dubbed “ArcaneDoor,” said the new zero-days were exploited to “implant malware, execute commands, and potentially exfiltrate data from the compromised devices.” 
    • “Cisco disclosed three vulnerabilities affecting its Adaptive Security Appliances — CVE-2025-20333CVE-2025-20363 and CVE-2025-20362 — but said “evidence collected strongly indicates CVE-2025-20333 and CVE-2025-20362 were used by the attacker in the current attack campaign.” 
    • “The Cybersecurity and Infrastructure Security Agency said those two zero-days pose an “unacceptable risk” to federal agencies and require immediate action.”
  • Dark Reading points out,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) this week disclosed that threat actors breached a federal agency last year by exploiting a critical vulnerability in the open source GeoServer mapping server.
    • “In the advisory, CISA said it conducted incident response at a large, unnamed federal civilian executive branch (FCEB) agency after malicious activity was flagged by the agency’s endpoint detection and response (EDR) platform, but found the agency’s response playbook to be lacking; so lacking in fact that it hampered CISA’s investigation and allowed the attackers to burrow deeper into the network unchecked.
  • Cybersecurity Dive adds,
    • “[On September 23, 2025,] the Cybersecurity and Infrastructure Security Agency urged security teams to monitor their systems following a massive supply chain attack that struck the Node Package Manager ecosystem. 
    • “The attack, tracked under the name Shai-Hulud, involved a self-replicating worm that compromised more than 500 software packages, according to StepSecurity. 
    • “After gaining access, a malicious attacker injected malware and scanned the environment for sensitive credentials. The credentials included GitHub Personal Access Tokens and application programming interface keys for various cloud services, including Amazon Web Services, Google Cloud Platform and Microsoft Azure. 
    • “The stolen credentials were uploaded to an endpoint controlled by the attacker and then uploaded to a public repository called Shai-Hulud. 
    • “Researchers at Palo Alto Networks said the attacker used an LLM to write the malicious script, according to an updated blog post released Tuesday.” 
  • Cybersecurity Dive relates,
    • “Hackers are conducting brute force attacks against the MySonicWall.com portal in order to access the company’s cloud backup service for firewalls, SonicWall and federal authorities warned in advisories released Monday [September 22, 2025].
    • “SonicWall said its investigation found that hackers gained access to 5% of backup firewall preference files. The company warned that while credentials inside the files were encrypted, the files contained other information that could help attackers exploit the firewall, according to the advisory.  
    • “SonicWall also released a video explaining the scope of the incident. 
    • In an advisory on Monday, the Cybersecurity and Infrastructure Security Agency urged customers to log into their accounts to determine whether their devices are at risk.” 
  • Cyberscoop reports,
    • “The Secret Service said Tuesday [September 23, 2025] that it disrupted a network of electronic devices in the New York City area that posed imminent telecommunications-based threats to U.S. government officials and potentially the United Nations General Assembly meeting currently underway.
    • “The range of threats included enabling encrypted communications between threat groups and criminals or disabling cell towers and conducting denial-of-service attacks to shut down cell communications in the region. Matt McCool, special agent in charge of the Secret Service’s New York field office, said the agency’s early analysis of the network indicated “cellular communications between foreign actors and individuals that are known to federal law enforcement.”
    • “In all, the agency said it discovered more than 300 servers and 100,000 SIM cards spread across multiple sites within 35 miles of the U.N. meeting. The Secret Service announcement came the same day President Donald Trump was scheduled to deliver a speech to the General Assembly.
    • “The potential for disruption to our country’s telecommunications posed by this network of devices cannot be overstated,” U.S. Secret Service Director Sean Curran said in a news release.”
  • Cyberscoop warns,
    • “Ambitious, suspected Chinese hackers with a slew of goals — stealing intellectual property, mining intelligence on national security and trade, developing avenues for future advanced cyberattacks — have been setting up shop inside U.S. target networks for exceptionally long stretches of time, in a breach that the researchers who uncovered it said could present problems for years to come.
    • “Mandiant and Google Threat Intelligence Group (GTIG) researchers described the campaign as exceptionally sophisticated, stealthy and complex, calling those behind it a “next-level threat.” But they don’t yet have a full handle on who the hackers are behind the malware they’ve dubbed Brickstorm, or how far it stretches. A blog post the company posted Wednesday sheds light on the group.
    • “The primary targets are legal services organizations and tech companies that provide security services, the researchers said. But the hackers aren’t limiting their interest to the primary targets, since they’ve used that access to infiltrate “downstream” customers. The researchers declined to describe those downstream customers or say whether U.S. federal agencies are among those targeted. A great many of them don’t know yet that they’re victims, they said.
    • “By stealing intellectual property from security-as-a-service (SaaS) firms, the hackers aim to find future zero-day vulnerabilities, a kind of vulnerability that is previously unknown and unpatched and thus highly prized, in order to enable more attacks down the line, the researchers from Mandiant and its parent company Google said.”
  • Per Dark Reading,
    • “Salesforce Web forms can be manipulated by the company’s “Agentforce” autonomous agent into exfiltrating customer relationship management (CRM) data — a concerning development as legacy software-as-a-service (SaaS) providers race to integrate agentic AI into their platforms to zhuzh up the user experience and generate buzz among investors.
    • “Agentforce is an agentic AI platform built into the Salesforce ecosystem, which allows users to spin up autonomous agents for most conceivable tasks. As the story often goes though, the autonomous technology appears to be the victim of the complexity of AI prompt training, according to researchers at Noma Security. 
    • “To wit: The researchers have identified a critical vulnerability chain in Agentforce, carrying a 9.4 out of 10 score on the CVSS vulnerability-severity scale. In essence it’s a cross-site scripting (XSS) play for the AI era — an attacker plants a malicious prompt into an online form, and when an agent later processes it, it leaks internal data. In keeping with all of the other prompt injection proofs-of-concept (PoCs) coming out these days, Noma has named its trick “ForcedLeak.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “RTX Corp., the parent firm of Collins Aerospace, confirmed that ransomware was used in the hack of its airline passenger processing software, in a filing with federal regulators
    • “The attack, discovered on Sept. 19, has disrupted flights across Europe since last week, including at London’s Heathrow Airport, Brussels Airport, and airports in Berlin and Dublin. 
    • “The Multi-User System Environment software, known as MUSE, is used by multiple airlines to check-in and board passengers and is also used to track baggage, according to the filing with the U.S. Securities and Exchange Commission. 
    • “Virginia-based RTX said the MUSE system operates on a customer-specific network outside of the company’s enterprise network.
    • “U.K. authorities said Wednesday that a man in his 40s had been arrested on suspicion of violating the Computer Misuse Act. The police investigation is ongoing.” 
  • Dark Reading points out,
    • “Volvo Group North America (Volvo NA) has been breached via a third-party human resources (HR) software provider.
    • “At the root of the story is Miljödata, a Swedish company specializing in occupational software-as-a-service (SaaS), whose cloud infrastructure was breached in August. Thanks to its centralized, multi-tenant arrangement, hundreds of customers and millions of individuals have been affected. In a recent letter to its staff, Volvo NA, whose parent company is based in Sweden, revealed itself to be one such victim.
    • “Like other Miljödata customers, Volvo NA’s systems were untouched by the attack. Still, its employees’ names and Social Security numbers (SSNs) were stolen, and potentially published to the Dark Web. According to its website, Volvo NA employs just shy of 20,000 people.
    • “For municipalities, universities, and even big corporations like Volvo, this isn’t just a security issue, it’s an integrity issue,” says Anders Askasen, vice president of product marketing at Radiant Logic. “People suddenly wonder whether the systems handling their most sensitive data are fit for the purpose, and with good reason. That loss of confidence is as damaging as the leak itself.”
  • Industrial Cyber tells us,
    • “The Rhysida ransomware gang claimed responsibility for a late-August data breach at the Maryland Transit Administration. Exposed data includes names, surnames, dates of birth, driver’s licenses, SSNs, passports, and confidential information.
    • “The group is said to have demanded a ransom of 30 bitcoin, around US $3.4 million at the time of writing, to be paid within seven days. To support its claim, Rhysida posted images of documents allegedly stolen from the MTA, including scans of a Social Security card, driver’s license, passport, and several other records.
    • “Comparitech identified that to prove its claim, Rhysida posted images of what it says are documents stolen from the MTA. They include scans of a Social Security card, driver’s license, passport, and several other documents. 
    • “The Maryland Transit Administration is a division of the state’s Department of Transportation. It operates buses, light rail, subways, commuter trains, taxis, and a paratransit system. The MTA specifically mentioned the paratransit system, MobilityLink, being disrupted by the cyber attack.”
  • Per the Record,
    • “Ransomware hackers stole Social Security numbers, financial information and more during a recent cyberattack on Union County in Ohio. 
    • “The county government began sending out breach notifications to 45,487 local residents and county employees this week. The letters say ransomware was detected on the county’s network on May 18, prompting officials to hire cybersecurity experts and notify federal law enforcement agencies.  
    • “The hackers stole documents that had names, Social Security numbers, driver’s license numbers, financial account information, fingerprint data, medical information, passport numbers and more.  
    • “No ransomware gang has taken credit for the attack publicly, and the letters said the county has been monitoring internet sources but have not found any indication the stolen information was released or offered for sale.  
    • “The county has about 71,000 residents and is 45 minutes outside of Columbus — which dealt with its own ransomware attack one year ago.” 
  • HIPAA Journal lets us know,
    • “There’s good and bad news on the ransomware front. Attacks are down year-over-year; however, successful attacks are proving even costlier to mitigate, according to the Mid-Year Risk Report from the cyber risk management company Resilience. The company saw a 53% reduction in cyber insurance claims in the first half of the year, which indicates organizations are getting better at preventing attacks; however, when ransomware attacks succeed, they have been causing increased financial harm, with losses 17% year-over-year. While ransomware accounted for just 9.6% of claims in H1, 2025, ransomware attacks accounted for 91% of incurred losses.
    • “On average, a successful ransomware attack causes $1.18 million in damages, up from $1.01 million in 2024, and the cost is even higher in healthcare. Resilience’s healthcare clients suffered average losses of $1.3 million in 2024, and in the first half of 2025, some healthcare providers faced extortion demands as high as $4 million. While it is too early to tell what the severity of claims will be in 2025 until claims are settled, Resilience said there are indications that the average severity of incurred losses for healthcare ransomware attacks this year could be $2 million, up from an average of $705,000 in 2024 and $1.6 million in 2023.”

From the cybersecurity defenses front,

  • Cyberscoop advises,
    • “Artificial intelligence is no longer a future concept; it is being integrated into critical infrastructure, enterprise operations and security missions around the world. As we embrace AI’s potential and accelerate its innovation, we must also confront a new reality: the speed of cybersecurity conflict now exceeds human capacity. The timescale for effective threat response has compressed from months or days to mere seconds. 
    • “This acceleration requires removing humans from the tactical security loop. To manage this profound shift responsibly, we must evolve our thinking from abstract debates on “AI safety” to the practical, architectural challenge of “AI security.” The only way to harness the power of probabilistic AI is to ground it with deterministic controls.”
  • A Dark Reading commentator recommends that “With the emergence of AI-driven attacks and quantum computing, and the explosion of hyperconnected devices, zero trust remains a core strategy for security operations.”
  • Per a CISA news releases,
    • “In today’s increasingly interconnected industrial landscape, operational technology (OT) systems are no longer isolated islands of automation—they’re deeply entwined with information technology and business networks, making them prime targets for cyber threats. Recognizing this growing risk, the Cybersecurity and Infrastructure Security Agency (CISA) collaborated with three U.S. federal agencies and five international partners and received contributions from twelve private sector stakeholders to develop and publish, “Foundations for OT Cybersecurity: Asset Inventory Guidance for Owners and Operators”.
    • “This key resource helps owners and operators of OT systems create stronger, more secure infrastructures by building a clear inventory and classification of their assets. By identifying, organizing, and managing OT assets effectively, organizations can not only improve cybersecurity but also enhance operational reliability, safety, and resilience.”
  • Per National Institute of Standards news releases,
    • “NIST has released Special Publication (SP) 800-88r2 (Revision 2), Guidelines for Media Sanitization.
    • “Media sanitization is a process that renders access to the target data on media infeasible for a given level of effort. This guide will assist organizations and system owners in setting up a media sanitization program with proper and applicable methods and controls for sanitization and disposal based on the sensitivity of their information.”
  • and
    • “NIST has released Special Publication (SP) 800-90C, Recommendation for Random Bit Generator (RBG) Constructions. It is the final document in the SP 800-90 series, which supports the generation of high-quality random bits for cryptographic and non-cryptographic use.
    • “SP 800-90C specifies constructions for implementing random bit generators (RBGs) that include deterministic random bit generator (DRBG) mechanisms as specified in SP 800-90A and use entropy sources as specified in SP 800-90B.”
  • Here is a link to Dark Reading’s CISO Corner.

Thursday report

From Washington, DC,

  • The Wall Street Journal reports,
    • “The U.S. government is hurtling toward a shutdown in a matter of days with no exit ramp in sight, as Republicans and Democrats latch onto starkly different positions and the White House threatens to lay off more federal workers.
    • “Republicans are seeking a seven-week extension in federal funding at current levels, and they have dismissed Democrats’ demands for hundreds of billions of dollars in healthcare spending. In a move to raise the political pressure, President Trump’s budget chief late Wednesday vowed to use any lapse in funding to make deeper cuts in the federal workforce, a threat Democrats rejected as blackmail.
    • “Democrats see the funding deadline as a rare opportunity to shape legislation, and the party’s base voters are desperate for elected representatives to show more fight after months of demoralizing political defeats. Republicans are loath to offer any concessions, putting both parties on a collision course ahead of the Oct. 1 deadline.
    • “Democrats have “asked us to do something that’s totally unreasonable,” President Trump told reporters on Thursday. Asked about the possibility of a shutdown, he said: “Could be. Because the Democrats are crazed. They don’t know what they are doing.”
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) has said he plans to stand firm this time and demand bipartisan talks, rather than acquiesce to a Republican plan to keep the government open, like he did in March. He said Democrats won’t be intimidated by the latest threat of federal layoffs.
    • “This is one of their threats, and their threats are not going to succeed,” Schumer said in an interview. “A lot of my colleagues who I’ve talked to today are very angry about this.”
  • Per Roll Call,
    • “Sources on both sides of the aisle and nonpartisan analysts agreed that, beyond the tough talk, top congressional Democrats have a weak hand to play and no discernible strategy for extracting the concessions from President Donald Trump and GOP leaders that they want on health care policy.
    • “A shutdown for the sake of a shutdown doesn’t help anyone,” a former Democratic congressional aide granted anonymity to speak candidly said. “If there is a shutdown, there also needs to be a plan to get out of it — and it will require a deal on all sides to end it, at a time when tensions would be even higher. It’s hard to turn back to bipartisan negotiations after that.”
  • Federal News Network adds,
    • “The Trump administration is taking a more aggressive approach than usual to what would happen in a government shutdown, after a White House memo Wednesday night told agencies to plan for further reductions in force if government funding lapses early next week.
    • “But with just days left before a government shutdown, many are questioning the ability for agencies to put together further RIF plans at all, since the reduction-in-force process is typically complicated and time-consuming, often taking months or longer.”
  • Bloomberg reports,
    • “The US will impose a 100% tariff on branded or patented pharmaceuticals, President Donald Trump announced Thursday.
    • “Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America,” Trump said in a social media post.
    • “Trump said there would be no tariffs on pharmaceutical products if companies have broken ground on a US manufacturing plant, or if such a plant is under construction.”
  • and
    • “Pharmacy middlemen are working on a proposal to voluntarily change some of their business practices to avoid new regulation from the Trump administration.
    • “The proposals under discussion include ensuring patients don’t pay more than a pharmacy would charge to someone without insurance and increasing the use of lower-cost versions of expensive biologic drugs.
    • “The Pharmaceutical Care Management Association has drafted proposals to bring to the Centers for Medicare and Medicaid Services, according to a document viewed by Bloomberg News.”
  • The American Medical Association adds,
    • “The Department of Commerce Sept. 24 released a notice seeking public comment on an investigation it launched Sept. 2 on imports of personal protective equipment, medical consumables and medical equipment under Section 232 of the Trade Expansion Act of 1962. The provision authorizes the president to impose tariffs or other trade restrictions if an investigation determines that the importation of particular goods affects national security. The department is seeking comment on a range of criteria, including the current and projected demand for PPE, medical consumables and medical equipment; the extent to which production can meet demand; the role of foreign supply chains in meeting U.S. demand; the concentration of U.S. imports of those products and more. Comments are being accepted for 21 days following publication in the Sept. 26 Federal Register.”
  • Bloomberg tops it off with this,
    • “Three hours inland from Chennai, India, traffic crawls on a half-finished road past rice fields and cow crossings until it reaches a newer complex of neat white buildings. Among them is the cancer wing of a hospital founded over a century ago by American missionaries.
    • “By morning, the line of people waiting to be seen at Christian Medical College Vellore’s Ranipet Campus snakes from the parking lot to the front door. In a basement treatment room one day in May, several of those who’ve made it inside sit in beds getting an intravenous drip of a Bristol Myers Squibb Co. drug called Opdivo or a competing Merck & Co. drug, Keytruda. A single infusion might cost at least $7,000 at the standard dose in the US, and a year’s treatment more than $200,000. Here, by financial necessity, most of the patients are getting as little as one-sixth of that.  
    • “The remarkable thing is that the radically low doses may also be effective at keeping cancer sufferers alive, doctors here and in other hospitals across India say. The science isn’t settled, but hospitals in Israel, France, the Netherlands, Canada and the UK are all testing or implementing more modest dose reductions. A small trial in the US also found some benefits. The consequences could be dramatic, expanding access to cancer treatment in poor countries and bending the curve of skyrocketing drug prices in the developed world. Smaller doses could also help limit the serious side effects many patients endure, from diarrhea to thyroid problems.
    • “A broad reevaluation of dosing has the potential to benefit hundreds of thousands of people in developing countries who otherwise wouldn’t be able to afford the drugs. One obstacle has stood in the way: the drugmakers themselves. Paid per dose, they stand to lose billions of dollars if doctors prescribe less medicine to their patients.”
  • From ARPA-H news releases
    • The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new research and development opportunity through its Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) program. THRIVE intends to develop integrated platform technologies to accelerate precision genetic medicines (PGMs) and provide single-intervention precision treatments to slow, reverse, or prevent diseases at the genetic level. The program is designed to optimize affordability, scalability, and sustainability of lifesaving PGMs for patients through existing regional treatment centers and virtual clinics. This will allow patients to be seen and treated where they live.” * * *
    • “Learn more about THRIVE on its program page, including information about the solicitation and Proposers’ Day.” 
  • and
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new funding opportunity through its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. With cutting-edge production technologies, the program seeks to establish the U.S. as a frontrunner in advanced manufacturing methods for high-quality genetic medicines.” * * *
    • “Learn more about GIVE on its program page, including information about the ISO solicitation and Proposers’ Day registration.”
  • Per a U.S. Office of Personnel Management news release,
    • The U.S. Office of Personnel Management (OPM) today announced record levels of engagement and leadership from the Chief Human Capital Officers Council (CHCOC) under the Trump Administration, underscoring the Council’s critical role in driving forward personnel policy and workforce reform across the federal government. The Chief Human Capital Officers Council is the principal interagency forum for federal human capital leaders, bringing together the Chief Human Capital Officers from across the Executive Branch to coordinate policy, share best practices, and advance government-wide workforce initiatives.
    • Since January of this year, the Council has held 71 sessions, an increase of almost double compared to the 40 sessions held last year. These sessions cover everything from discussing the Deferred Resignation Program and return-to-office policies to SES performance and collective bargaining. Between January and March alone, the Council convened 34 times in just 50 workdays. Alongside these sessions, the Council has distributed more than 200 communications to federal agencies this fiscal year, including official memos, weekly updates, and special notices.
  • OPM also recently posted Benefits Administration Letter 25-102 about FEHB Enrollment Coordination for Married Federal Employees and Annuitants.
  • Avalere Health discusses an upcoming meeting at which new ICD-10 codes for 2026 will be selected.

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “Capricor Therapeutics executives came out of a meeting with Food and Drug Administration officials confident that they can reverse a rejection of their experimental cell therapy for Duchenne muscular dystrophy. 
    • “The FDA turned down Capricor’s application for the drug, deramiocel, in July after questioning the research supporting its effectiveness. At the time, Capricor CEO Linda Marbán said the rejection was a surprise and that no major issues had been raised during the review.
    • “Now, FDA officials are indicating that they will reconsider the application with new data from a clinical trial called Hope-3 that’s already been completed, Capricor said Thursday. That’s important because Capricor won’t have to start all over with a new submission. “This is a giant win for us,” Marbán said during a conference call with analysts. Initial trial results are expected in the middle of the fourth quarter.”
  • and
    • “The Food and Drug Administration on Thursday approved a new medicine for breast cancer, clearing Eli Lilly’s Inluriyo for people with a specific genetic mutation.
    • “Previously known as imlunestrant, the drug has been cleared for use in a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one hormone therapy. The approval makes the treatment available specifically to people who fit that criteria and have mutations to a gene called ESR1 — an alteration Lilly believes to occur in about half of people with that form of the disease either during, or after, exposure to hormone therapy.
    • “The clearance was based on results published in the New England Journal of Medicine last year. Those findings, from a study called EMBER-3, showed that Inluriyo helped reduced the risk of disease progression or death among those with ESR1 mutations by 38% when compared to standard hormone-suppressing therapies. Inluriyo delayed tumor progression by a median of 5.5 months, or close to 2 months longer than those on typical drugs.”  
  • and
    • “Heartflow has received 510(k) clearance for an updated version of its plaque analysis algorithm, the company said Monday.
    • “The updated algorithm shows a 21% improvement in plaque detection, compared to the original version of the technology, the company said. 
    • “Heartflow disclosed the clearance alongside news that Cigna has become the second national insurer after UnitedHealthcare to update its policies to cover the plaque analysis product.”
  • MedPage Today points out,
    • “A risk evaluation and mitigation strategies (REMS) program is no longer required for the thyroid cancer therapy vandetanib (Caprelsa), the FDA announced on Thursday.
    • “The agency had required the safety program for vandetanib to ensure appropriate heart rhythm monitoring and safe use since its approval in 2011opens in a new tab or window as treatment for medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed.
    • The approval of vandetanib was based on results from the phase III randomized ZETA trial in which patients randomized to receive vandetanib experienced a 65% reduction in the risk of disease progression compared to patients on placebo. A REMS was required for vandetanib due to potential for QT prolongation and reported cases of torsades de pointes and sudden death in patients taking the drug.
  • Fierce Pharma informs us,
    • “After nearly two decades in the endocrine scene, Crinetics is making its commercial debut with the approval of a game-changing treatment for the rare growth disorder acromegaly.
    • “The FDA on Thursday signed off on Crinetics’ paltusotine—now christened Palsonify—as a first-line treatment for adults with acromegaly for whom surgery didn’t work or isn’t an option.
    • “The drug is a selectively targeted somatostatin receptor type 2 (SST2) agonist. Unlike other somatostatin drugs that make up the bulk of current acromegaly care options, Palsonify is a small molecule, non-peptide therapy that can be taken orally, freeing up patients from frequent and often painful injections.
    • “The treatment marks the “next level of care for patients with acromegaly,” Scott Struthers, Ph.D., co-founder and CEO of Crinetics, said in a recent interview with Fierce Pharma, staking that claim on the drug’s ability to both help control patients’ hormone levels and address their symptoms in a once-daily treatment option.”
  • Per FDA news release,
    • “Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the progression of the disease in children 6 to 12 years old at the initiation of treatment.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal court has tossed a rule outlining how auditors must review Medicare Advantage insurance companies for overpayments, adding uncertainty to the federal government’s plan to audit every plan annually.
    • “On Thursday, Judge Reed O’Connor, of the U.S. District Court for the Northern District of Texas in Fort Worth, vacated the 2023 Medicare Risk Adjustment Data Validation, or RADV, rule, on the grounds that regulators violated the Administrative Procedure Act of 1946.”
    • “Under the rule, which was finalized in January 2023, the Centers for Medicare and Medicaid Services eliminated a key statistical tool, the fee-for-service adjuster, used to compare error rates in traditional Medicare versus Medicare Advantage. Regulators planned to apply the new audit method retroactively to insurers’ risk-adjustment code reviews dating back to 2018. When the rule was finalized, CMS estimated that the more stringent reviews would result in insurers returning $4.7 billion to the agency between 2023 and 2032. 
    • “Humana sued over the rule in September 2023, alleging the new audit methodology held private Medicare insurers to a higher standard than the fee-for-service program. 
    • “O’Connor sided with the insurer.  In a Thursday order, he ruled that CMS failed to adequately notify the industry that actuarial equivalence between traditional and Medicare Advantage plans no longer applied.
    • “Because there was no meaningful notice of defendants’ ultimate finding that actuarial equivalence does not apply to RADV audits, there was no meaningful dialogue regarding the costs and benefits of the surprise changes,” O’Connor wrote in the order.” 

From the public health and medical / Rx research front,

  • MedPage Today lets us know,
    • “Women who missed their first screening mammogram had a 53% higher risk of stage III breast cancer over the next 25 years and almost a fourfold higher risk of stage IV breast cancer.
    • “Breast cancer mortality was 40% higher among screening nonparticipants.
    • “Breast cancer incidence was nearly identical, suggesting the increased risk of later-stage diagnosis and breast cancer mortality resulted from delayed detection.”
  • Per Health Day,
    • “During August 2021 to August 2023, only 36.4 percent of U.S. adults had no cardiovascular disease (CVD) risk factors, according to a September data brief published by the National Center for Health Statistics.
    • “Catharine A. Couch, Ph.D., R.D., from the National Center for Health Statistics in Baltimore, and colleagues presented prevalence estimates for none, one, or two or more CVD risk factors (uncontrolled high blood pressure, uncontrolled high blood lipids, uncontrolled high mean blood glucose, and high body mass index) in U.S. adults from August 2021 to August 2023.
    • “The researchers found that 36.4, 34.9, and 28.7 percent of U.S. adults had no, one, and two or more CVD risk factors, respectively. More men than women had two or more CVD risk factors (31.7 versus 25.8 percent). With age, there was a decrease in the percentage of adults with no CVD risk factors, while a higher percentage of older adults had one or two or more CVD risk factors. Those with family income 350 percent or more of the federal poverty level had the highest percentage of adults with no CVD risk factors and the lowest percentage with two or more CVD risk factors. The percentage of adults with two or more CVD risk factors increased from 2013 to 2014 to August 2021 to August 2023.”
  • and
    • “Physical frailty may contribute to the development of dementia, according to a study published online Sept. 17 in Neurology.
    • “Xiangying Suo, from the School of Public Health of Zhengzhou University in China, and colleagues conducted a prospective cohort study based on U.K. Biobank participants without dementia to examine the link between physical frailty and dementia. Five criteria were used to define physical frailty (weight loss, exhaustion, physical inactivity, slow walking speed, and low grip strength).
    • “A total of 8,900 dementia cases were documented during a median follow-up of 13.58 years among 489,573 participants. The researchers found that the risk for dementia was significantly higher in those with prefrailty and frailty compared with nonfrail individuals (hazard ratios, 1.50 and 2.82, respectively). Compared with those with low genetic risk and nonfrailty, the highest risk for dementia was seen for participants with frailty and high genetic risk (hazard ratio, 3.87 for high polygenic risk score; 8.45 for APOE-ε carriers). A potential causal relationship was seen between physical frailty and dementia in the forward Mendelian randomization (MR) analysis (odds ratio, 1.79), while a null causal association was suggested in the reverse MR. Potential underlying mechanisms linking physical frailty to dementia include genetic background and neurologic and immunometabolic function.”
  • BioPharma Dive considers “Cancer patients are living longer than ever. Pain drugmakers haven’t kept up. Decades of slow-moving research, along with broader failures of the healthcare system, have left millions of people in daily pain. Doctors fear that’s bound to continue.”
  • BioPharma Dive also notes,
    • “Eli Lilly has canceled one clinical trial of an experimental muscle-sparing obesity drug, citing “strategic business reasons,” according to a federal database. The study was one of two Phase 2 trials testing the drug, known as bimagrumab, alone or with Lilly’s marketed medicine in people with obesity. The now-halted study included Type 2 diabetics as well.
    • “In an email to BioPharma Dive, a Lilly spokesperson said company executives “routinely evaluate our clinical development programs to optimize the potential for each product” and noted that a separate trial involving non-diabetic people with obesity is still underway. The trial stoppage was first reported by Bloomberg.
    • “Bimagrumab is among the drugs designed to preserve muscle in people taking weight loss drugs like Zepbound and Novo Nordisk’s Wegovy, which can cut lean mass as well as fat. But at least one biotech has said that additive weight loss effects are an approval requirement, suggesting higher clearance standards have been established by the Food and Drug Administration.”
  • The Washington Post explains why the brain hangs on to some memories but allows others to fade. Tying “fragile” memories to emotional events could help people remember them better in the future, researchers at Boston University believe.”
  • Per a National Institutes of Health news release,
    • “Today, the National Institutes of Health (NIH) announced the award of contracts for launching the Standardized Organoid Modeling (SOM) Center, a national resource that will be dedicated to using cutting-edge technologies to develop standardized organoid-based new approach methodologies (NAMs) that deliver robust, reproducible, and patient-centered research findings. With contracts totaling $87 million for the first three years, the center will be housed at the Frederick National Laboratory for Cancer Research (FNLCR), a facility supported by NIH’s National Cancer Institute (NCI). The center’s goal will be to leverage the latest technologies to enable real-time optimization of organoid protocols.
    • “This groundbreaking initiative will transform how we conduct biomedical research through innovative approaches to advancing human-based technologies,” said NIH Director Dr. Jay Bhattacharya. “By creating standardized, reproduceable, and accessible organoid models, we will accelerate drug discovery and translational science, offering more precise tools for disease modeling, public health protection, and reducing reliance on animal models.”

From the AI front,

  • STAT New reports,
    • “Artificial intelligence may help radiologists spot disease, but throwing the technology at millions of CT scans or mammograms is not without risks to patients and may drive up costs without showing much benefit. Katie Palmer reports on two efforts to prove out the potential.
    • “A large randomized controlled trial will explore the value of AI-aided mammography in screening for breast cancer. The technology is already widely used in the U.S., but the best evidence that it’s useful comes from Europe. The $16 million trial is funded by the Patient-Centered Outcomes Research Institute. Read more on what researchers may find here.
    • “Next month, NYU Langone Health will begin checking bone density in CT scans of people over 65 for osteoporosis, a condition that often goes undetected until someone breaks a bone. The health system may expand the work if it’s proven to help. This kind of opportunistic screening, which repurposes otherwise acquired scans, could be used to identify many treatable conditions. Katie’s interview is worth a read.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health closed another fiscal year with operations in the red, with the large Catholic nonprofit pointing to expenses growth outpacing revenues “despite strong volume, salary cost management and higher productivity.”
    • “The 138-hospital system reported an as-recorded operating loss of $687 million (-1.8% operating margin) for the fiscal year ended June 30, 2025, as compared to the prior year’s $581 million operating loss (-1.5% operating margin).
    • “However, after adjustments to normalize delayed income from the California Provider Fee Program, CommonSpirit somewhat improved its stature with a $225 million operating loss (-0.6% adjusted operating margin) as opposed to fiscal 2024’s $875 million operating loss (-2.4% adjusted operating margin).
    • “Net income in fiscal 2025 was $1.1 billion as recorded and nearly $1.6 billion as adjusted, both increases over the prior year’s respective $797 million and $503 million.”
  • and
    • “Value-based cancer care navigation company Thyme Care raised $97 million in series D funding backed by major strategic investors across payers, employers, health systems and retail health.
    • “The latest funding propels Thyme Care’s valuation to north of $1 billion, a 2x increase from its valuation in July 2024 when it raised $95 million, according to a company spokesperson.
    • “The company plans to use the new funding to expand its business across verticals and to take on more breaking points in the oncology journey that drive up costs and cause friction in the patient experience, Robin Shah, CEO and co-founder of Thyme Care, told Fierce Healthcare.
    • “Thyme Care is now focused on tackling treatment denials, high drug costs and “the barriers that delay or prevent access to timely, affordable and appropriate care,” Shah said.’
  • and
    • “Medicare Advantage (MA) has been a consistent earnings booster for insurers, but recent challenges in this space are likely to ding profitability, according to a new report.
    • “Analysts at AM Best found that elevated utilization trends beginning in 2023 led to a $5.7 billion underwriting loss in 2024 for MA plans, while insurers reported gains in the previous five years. Underwriting gains in MA accounted for 40% of total gains from 2019 to 2022, but that dropped to 20% in 2023.
    • “The report found that close to three-quarters of companies with a significant concentration in MA reported underwriting losses in 2024.
    • “Medicare Advantage enrollment and premium continue to grow as more people are aging into the program. However, plans have experienced an increase in utilization and medical trends that have persisted longer than expected,” said Jason Hopper, associate director for industry research and analysis at AM Best, in a press release.
    • “Changes to the risk-adjustment payment model by the Centers for Medicare and Medicaid Services, as well as lower Star Ratings across the industry, also have contributed to recent underwriting losses,” Hopper said.
  • MedTech Dive informs us,
    • “Guardant Health and Quest Diagnostics will collaborate to offer Guardant’s Shield blood-based colorectal cancer test through Quest’s distribution network, the companies said Wednesday.
    • “Physicians will be able to order the test through their Quest accounts and electronic health record starting in the first quarter of 2026.
    • “In an investor day presentation, Guardant Co-CEO AmirAli Talasaz also revealed plans to expand Shield to include multi-cancer detection. The multi-cancer offering will be available nationally in October.”
  • Modern Healthcare reports,
    • “As more upstarts strive to make a splash in the pharmacy benefit manager sector, RxBenefits CEO Robert Gamble thinks his company has devised something truly novel.
    • “Like other companies seeking to disrupt a market dominated by CVS Health subsidiary CVS Caremark, UnitedHealth Group division Optum Rx and Cigna unit Express Scripts, Illuminate Rx promises pharmacy benefits without spread pricing or hidden fees, and with transparency and a focus on generic and biosimilar drugs. The company launched Illuminate Rx this month.
    • “What Gamble said differentiates this offering is that RxBenefits has added an in-house PBM to its marketplace platform, where self-funded employers, brokers and benefits consultants can select among Illuminate Rx and other PBMs for the best deals.”
    • “RxBenefits, which serves 3 million insurance members and manages $3 billion in annual pharmacy spending, named veteran executive Gamble as CEO last December following Wendy Barnes’ departure to become president and chief executive of the pharmaceutical discount vendor GoodRx.”

Tuesday report

From Washington, DC

  • Roll Call reports,
    • “President Donald Trump abruptly canceled his meeting with top Democratic leaders that had been planned for Thursday to search for a deal that might avert a partial government shutdown next week.”
  • The American Hospital Association News tells us,
    • ‘The Department of Homeland Security today released a proposed rule to amend the process for selecting among prospective applicants — known as registrants — for H-1B visas that are subject to statutory numerical caps. The rule would change the agency’s current process of conducting random selections to a weighted selection process. Weighted selections would be based on an individual’s wage level, with higher wage levels weighted more heavily. The rule would also apply the process to registrations subject to the regular cap and to those asserting eligibility for the H-1B advanced degree exemption. The proposal would require the use of additional wage level information, including the Occupational Employment and Wage Statistics wage level, Standard Occupational Classification code and the area of intended employment.”
  • and
    • “The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following reports of device components detaching during procedures. The company was alerted to incidents resulting in one patient death and one injury. The product is designed to be used with ultrasound endoscopes for lung cancer biopsies. In response to the reports, Olympus has implemented an automated inspection procedure during assembly to help improve the detection of device damage, which is a step that was previously done through a visual inspection. The FDA said health care personnel treating patients with the product must ensure it is not from an affected lot.”
  • Milliman delves into why “many Medicare beneficiaries will spend less than expected to reach the IRA’s new $2,000 out-of-pocket spending limit.”
    • “Among other changes to the standard Part D benefit design, the IRA introduces a hard MOOP—once the beneficiary attains $2,000 in TrOOP costs in 2025, they are no longer responsible for any cost sharing—aligning the TrOOP more closely with the typical definition of a MOOP.5 Another important change introduced by the IRA is that cost sharing for basic Part D coverage counts toward the MOOP, even if that basic coverage is reduced by certain other payers.6 Federal regulators refer to the amount of drug cost that accumulates (or counts) toward the MOOP in Part D as “TrOOP eligible cost.”7 For enhanced plans,8 TrOOP eligible cost is based on the greater of defined standard benefit cost sharing and the actual patient out-of-pocket (including any cost-sharing subsidies), such that actual patient out-of-pocket will never be higher than TrOOP eligible costs.9 This regulatory guidance has been referred to as the “greater of” logic.
    • “This “greater of” provision is impactful because the defined standard benefit is frequently leaner (i.e., has higher cost sharing) than the benefit a beneficiary may actually have. In fact, around 90% of non-low-income (unsubsidized) beneficiaries are enrolled in plans with enhanced benefits.10 Enhanced plans generally offer fixed copays on generic tiers, either coinsurance or copays on brand tiers, and coinsurance on specialty tiers. Plans are considered “enhanced” if they are meaningfully richer than the defined standard benefit. Other plans are considered “basic” and are roughly equivalent in richness to the defined standard benefit.11
    • “The IRA’s accumulation logic means many beneficiaries who satisfy their MOOP will do so without spending $2,000 out-of-pocket—i.e., their specific MOOP will be less than their $2,000 limit in TrOOP eligible costs. Assuming enhanced benefits similar to 2024, we expect roughly half of non-low-income beneficiaries who reach MOOP will spend less than $1,200 out-of-pocket in 2025.12
    • “Most likely, the only beneficiaries who will pay the full $2,000 to satisfy their MOOPs in 2025 will be non-low-income beneficiaries who are enrolled in a plan with basic Part D coverage13 or who are in an enhanced plan but exclusively utilize drugs with cost sharing greater than or equal to what is under (i.e., leaner than) the defined standard benefit. The most common instance of the latter occurs for specialty drugs on tier 5, which are almost always subject to a coinsurance greater than or equal to the defined standard coinsurance amount. In some cases, this could also occur for non-preferred brand (tier 4) drugs, where the plan offers a coinsurance benefit (typically 40% to 50%, compared to the defined standard 25%).”
  • The HHS Inspector General released a report
    • “Congress appropriated $178 billion to HHS to provide funds to eligible providers for health care-related expenses or lost revenue attributable to COVID-19 under the Provider Relief Fund (PRF) program. HHS was responsible for initial PRF program oversight and policy decisions, and HRSA administered the PRF program.
    • “Under the PRF terms and conditions, if a patient had health insurance and sought COVID-19 treatment from an out-of-network provider that received PRF payments, the provider would not seek to collect out-of-pocket payments greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. (We refer to this as the “balance billing requirement.”)
    • “This audit assessed whether selected hospitals that received PRF payments complied with the balance billing requirement for COVID-19 inpatients.
    • “Of the 25 selected hospitals, 17 billed patients an amount that did not comply or may not have complied with the balance billing requirement. For example, one hospital billed a patient $6,000 when the patient’s insurance carrier had waived all patient cost-sharing responsibility.
    • “Hospitals stated that they were uncertain how to comply with the requirement because HRSA did not provide sufficient guidance. If HRSA developed and provided early and detailed guidance, hospitals might not have improperly billed selected patients a total of $637,035 for services provided.”
  • Per a Justice Department news release,
    • “The Justice Department’s Criminal Division today announced the expansion of its Health Care Fraud Unit’s New England Strike Force to the District of Massachusetts. This expansion brings enhanced federal enforcement resources to one of the nation’s most significant health care and life sciences hubs.
    • “The U.S. Attorney’s Office for the District of Massachusetts has a national reputation in health care enforcement and has developed a significant record of success in investigating and prosecuting health care fraud, including complex cases involving pharmaceutical and medical device companies, providers, and executives. In FY 2025 alone, working together on health care fraud enforcement, the U.S. Attorney’s Office’s Health Care Fraud Unit and Affirmative Civil Enforcement Unit recovered more than $450 million in fraudulently obtained funds. Building on the U.S. Attorney’s Office’s historic track record and the success of the Criminal Division’s Health Care Fraud Unit’s specialized prosecutors and data-driven, multi-agency Strike Force model, the Department is deploying a powerful force multiplier, allowing it to accelerate the detection, investigation, and prosecution of complex fraud schemes throughout the District of Massachusetts.”

From the public health and medical/Rx research front,

  • NBC News reports,
    • “One of the largest measles outbreaks in the U.S. is now centered in bordering areas of southwestern Utah and Arizona. 
    • “In Southwest Utah, all but one of the 23 confirmed cases are among unvaccinated, school-age kids, the Southwest Utah Public Health Department reported. In Mohave County, Arizona, which health officials believe is connected to the Utah outbreak, there have been 42 confirmed cases of the highly contagious virus.
    • “An NBC News investigation, done in collaboration with Stanford University, has found that much of the United States doesn’t have the vaccine protection to prevent outbreaks of communicable diseases such as measles.”
  • Cardiovascular Business informs us,
    • “Approximately 6.7 million Americans over the age of 20 have heart failure, according to a new data-driven analysis published by the Heart Failure Society of America (HFSA). That number is expected to rise, the group added and could hit approximately 11.4 million by 2050.
    • “Those were just some of the eye-opening statistics included in a new HFSA report published in the Journal of Cardiac Failure.[1] In addition, the group wrote, approximately one in four Americans will develop HF in their lifetime. And the odds are even greater for Black individuals than those from other racial and ethnic groups.”
  • The Washington Post points out what researchers suspect may be fueling cancer among millenials.
  • Genetic Engineering and Biotechnology News notes,
    • “Neurological disorders, such as schizophrenia and bipolar disorder, remain challenging to diagnose due to the absence of objective biomarkers. Current assessments largely rely on subjective clinical evaluations. 
    • “In a new study published in APL Bioengineering titled, “Machine Learning-Enabled Detection of Electrophysiological Signatures in iPSC-Derived Models of Schizophrenia and Bipolar Disorder,” researchers from Johns Hopkins University (JHU) present a computational analysis pipeline designed to identify disease-specific electrophysiological signatures from patient-derived cerebral organoids and two-dimensional cortical interneuron cultures. The findings may help reduce human error when diagnosing mental health disorders that currently only rely on clinical judgement.”
  • Health Day lets us know,
    • “Tattoos might protect against melanoma
    • “People with more tattoos were less likely to develop melanoma
    • “They might take better care of their skin, or the tats might provide some sort of screen from UV rays, researchers say.”
  • Per the American Journal of Managed Care,
    • Colorectal cancer (CRC) screening rates remain lower in rural areas compared with urban communities, according to a new analysis of more than 535,000 adults in the US. Although education, income, insurance coverage, and provider access explain part of the disparity, more than 70% of the gap remains unaccounted for, pointing to deeper structural and cultural barriers that require equity-focused interventions.
    • ‘This analysis is published in Cancer Causes & Control.
  • Per Fierce Pharma,
    • “Moderna has early in-human data showing its next-generation COVID-19 vaccine, mNEXSPIKE, has the potential to offer strong immune protection against the latest rapidly spreading SARS-CoV-2 virus.
    • “Moderna’s updated mNEXSPIKE vaccine showed an average greater-than-16-fold increase in neutralizing antibodies against the LP.8.1 sublineage in individuals 12 years of age or older, the company said Tuesday. The result comes from a postmarketing clinical study of the latest 2025-26 formula of mNEXSPIKE, which is designed to target LP.8.1.
    • “By comparison, the company’s first-generation mRNA vaccine, Spikevax, generated a greater-than-eightfold increase in LP.8.1-neutralizing antibodies across the same age groups, Moderna said.”
  • Per BioPharma Dive,
    • “A drug combination involving Bristol Myers Squibb’s experimental medicine iberdomide met one of its main goals in a Phase 3 clinical trial, helping to eliminate signs of multiple myeloma in significantly more enrollees than a standard regimen, the company said Tuesday.
    • “The data are from an interim analysis of a study that will continue so trial investigators can measure other goals like an impact on disease progression and survival. Bristol Myers will submit the results to health regulators, although executives have previously said an approval would probably only come if iberdomide meets its other objectives.
    • “Iberdomide is one of three protein-degrading drugs Bristol Myers is positioning as successors to blockbuster blood cancer drugs like Revlimid and Pomalyst, which it acquired through its merger with Celgene. Many of the products in its large portfolio of cancer drugs have either plateaued or are in decline.”
  • Per Medscape,
    • “A compound comprising five agonists that together tackle weight loss, glucose reduction, insulin sensitization, and blood fat normalization has shown promise in mouse models of obesity.
    • “The compound under investigation is called a quintuple agonist because, together with GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, it contains lanifibranor, a molecule that activates three different peroxisome proliferator-activated receptors (PPARs) — the alpha, delta, and gamma variants — all of which are involved in energy regulation.
    • “Notably, this is not a combination therapy — the five agonists are included in a single molecule.
    • “Daniela Liskiewicz, PhD, Institute for Diabetes and Obesity, Helmholtz Zentrum München, Neuherberg, and the German Center for Diabetes Research, both in Munich, Germany, discussed the development of the novel agonist at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.”
  • Here’s a link to the National Institutes of Health’s Research Matters newsletter.
  • Beckers Hospital Review identifies “six new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • Per MedTech Dive,
    • “Multi-cancer blood tests, with the promise of detecting many cancer types from a single sample, have the potential to transform cancer screening.
    • “However, evidence is lacking to support broad use of the tests in people who do not have symptoms, according to research commissioned by the Agency for Healthcare Research and Quality and published last week in Annals of Internal Medicine.
    • “Researchers identified no completed, controlled studies reporting benefits in cancer detection, mortality or quality of life from screening with multi-cancer detection tests. They also found insufficient evidence on the accuracy and potential harm of the tests, mostly due to study limitations and unknown or inconsistent findings.
    • “Researchers from the RTI International – University of North Carolina Evidence-based Practice Center and The Ohio State University College of Medicine conducted the review.”

From the AI front,

  • The Wall Street Journal relates,
    • “AI models are being designed to predict a woman’s near-future risk of breast cancer using mammograms.
    • “Clairity’s AI model received FDA authorization and can predict a woman’s five-year breast-cancer risk.
    • “AI models outperform older risk-score calculators, but some doctors want more evidence of long-term impact.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Eli Lilly LLY said it plans to build a $6.5 billion facility in Houston to make active pharmaceutical ingredients, including for a new oral weight-loss drug.
    • “The plant will bring 615 jobs to the area, including engineers and lab technicians, as well as 4,000 construction jobs while it is being built, the company said Tuesday.
    • “Eli Lilly plans to manufacture orforglipron, its first oral, small molecule GLP-1 receptor agonist, at the facility. The company expects to submit orforglipron to global regulatory agencies as a treatment for people with obesity by the end of this year.”
  • Per Fierce Healthcare,
    • “Compared to their peers, hospitals acquired by private equity reduced salary spending, cut staffing levels and experienced higher mortality rates within their emergency departments, according to a Medicare claims analysis published this week in Annals of Internal Medicine.
    • “The research, which reviewed data from 2009 to 2019, also found salary and staffing cuts among the acquired hospitals’ intensive care units, but, unlike EDs, there was no significant difference in mortality compared to other hospitals. Patient transfer rates increased in both settings among the private-equity-acquired hospitals, particularly among sicker patients, and ICU length of stay decreased.
    • The analysis from University of Chicago, Harvard Medical School and University of Pittsburgh researchers is the latest contribution to a body of peer-reviewed evidence critical of private equity’s increasing presence among healthcare providers. It also follows a similar analysis from 2023 conducted by many of the same authors that spotted a rise in hospital-acquired adverse events among inpatients receiving care at a private-equity-acquired facility.”
  • and
    • “Pharmacy benefit manager Capital Rx has secured $400 million in fresh funding and announced a rebrand to better reflect its expansion beyond the pharmacy space.
    • “The investments include a $252 million series F round and other funding toward its securities, which is expected to close in October. Wellington Management and General Catalyst led the round, and additional supporters include Generation Investment Management, Growth Equity at Goldman Sachs Alternatives, 9Yards Capital, B Capital, Edison Partners, Prime Health Investments and Transformation Capital.
    • “With the infusion of cash, Capital Rx said it plans to lean more into its broader capabilities as a health benefits technology provider and will rebrand as Judi Health, the name of its proprietary tech stack. The company said the shift “marks a pivotal moment in addressing the fundamental inefficiencies of health benefits administration and the rising cost of care in the U.S.”
    • “The funding will also support the expansion of its PBM operations, Capital Rx said.”
  • and
    • “Health insurance startup Sidecar Health inked a partnership with Carrum Health to bring its specialty care network onto its platform.
    • “Carrum Health, a Fierce 15 of 2025 honoree, launched 10 years ago to develop value-based Centers of Excellence for employers, with the aim to revamp how the healthcare industry pays for and delivers specialty care. 
    • “Sidecar Health members will now have access to more than 1,200 vetted COE providers for surgical, cancer and substance use treatment—accessible to 90% of Americans within 50 miles of a Carrum provider, according to the companies. 
    • “Carrum’s solution makes specialty care services available at bundled prices and connects members to dedicated care navigation. The service also includes a 30-day warranty on surgery and two years on cancer care.”
  • Beckers Hospital Review relates,
    • “Walmart has expanded same-day pharmacy services to include refrigerated and reconstituted medications. 
    • “The expansion includes refrigerated access for medications such as insulin, GLP-1s and pediatric amoxicillin, according to a Sept. 22 news release from the company. Refrigerated medications make up over 30% of Walmart pharmacy sales and the company is the first retailer to deliver refrigerated prescriptions alongside everyday orders. 
    • “Once a prescription is filled, customers are notified through their Walmart pharmacy account and from there, can choose same-day scheduled delivery, on-demand delivery and express delivery with insurance applied.” 
  • BioPharma Dive tells us “why Xoma, a drug royalty firm, is hunting biotech ‘zombies.’ Distressed biotechs are facing rising investor pressure to close down, giving firms like Xoma an opportunity to step in and liquidate them for a profit.”
  • MedTech Dive explains “how SS Innovations is expanding robotic surgery’s reach. Heart surgeon Sudhir Srivastava saw a global need for less-invasive surgical care at an affordable price. His company, SS Innovations, built a robot that has now been used in over 5,000 surgeries.”

Cybersecurity Saturday

From the cybersecurity policy and law enforcement front,

  • The Wall Street Journal reports,
    • “The collapse on Friday [September 19] of an emergency federal funding bill leaves the fate of cybersecurity legislation that provides legal protection for companies sharing cyber-threat intelligence up in the air.
    • Without a reprieve of the expiring cyber legislation that had been included in the funding bill, companies face uncertainty on how to communicate about cyber threats as competing reauthorization bills work through a divided House and Senate.
    • “Both the private sector and the government need certainty, including the ability to allocate resources for long-term cybersecurity planning and implementation,” said Matthew Eggers, vice president of cybersecurity policy at the U.S. Chamber of Commerce. 
    • The 2015 Cybersecurity Information Sharing Act, or CISA, is set to expire at the end of September. Friday’s scuttled emergency funding measure, which applied to a number of federal programs and sought to avert a government shutdown, would have given lawmakers more time [until November 21] to iron out critical differences between House and Senate versions of CISA renewal bills. * * *
    • “A notable difference in the House bill is the forward-thinking inclusion of artificial intelligence in the renewal,” said Justine Phillips, a partner and co-chair of the data and cyber practice group at law firm Baker McKenzie. Despite these updates, she said, “the House bill is the functional equivalent of extending the act as is, because it leaves the legal liability protections intact.”
    • “The cyber bill’s renewal by the Senate may prove more problematic, cybersecurity experts say.”
  • Cyberscoop informs us,
    • “Federal agencies are increasingly incorporating artificial intelligence into the cyber defenses of government networks, and there’s more still to come, acting Federal Chief Information Security Officer Michael Duffy said Thursday.
    • “We’re at an exciting time in the federal government to see that we’re not only putting AI in production, but we’re finding ways to accelerate emerging technology across the government, across all missions and all angles,” Duffy said at FedTalks, produced by Scoop News Group. In his “role overseeing federal cybersecurity policy,” he said, he is “able to see these at the ground level, as agencies bring excitement and enthusiasm and hope for what they can optimize through artificial intelligence.”
    • “Cyber attackers are moving faster than ever, and on a much larger scale than before, he said. They’re also using technology in new ways. But it’s not all “doom and gloom” when it comes to the cybersecurity of federal networks, especially because of feds’ move toward AI, Duffy said.
    • “I’m pleased to say that the advancements that we’ve made over the past decade in the federal government have brought us to this point: Agencies are poised now, postured, positioned, to take advantage of new capabilities, bring them into federal agencies and make them work for the mission,” he said.”
  • In related news, Cybersecurity Dive tells us,
    • “The National Institute of Standards and Technology on Thursday [September 18] published guidance describing how implementation of post-quantum cryptography (PQC) both supports and relies on the safeguards in the agency’s major cybersecurity publications.
    • “The draft NIST document, derived from the output of the agency’s PQC migration project, is designed to illustrate the connections between the tools required for adopting quantum-resistant encryption and the security practices that NIST recommends in its Cybersecurity Framework and other guidance.
    • “The capabilities demonstrated in the project support several security objectives and controls identified” in other NIST guidance documents, the agency said in its new publication. “At the same time, responsible implementation of the demonstrated capabilities is dependent on adherence to several security objectives and controls identified in these risk framework documents.”
    • “Collecting information about which technologies use cryptography supports the Cybersecurity Framework practices of creating hardware and software inventories, the document notes. Similarly, analyzing cryptographic weaknesses supports the CSF practice of identifying vulnerabilities in technology assets.”
  • A September 19, 2025, NIST news release adds,
    • “To help organizations protect their data against possible future attacks from quantum computers, the National Institute of Standards and Technology (NIST) has released a publication offering guidelines for implementing a class of post-quantum cryptography (PQC) algorithms known as key-encapsulation mechanisms, or KEMs.
    • “A KEM is a set of algorithms that can be used by two parties to securely establish a shared secret key over a public channel — a sort of first handshake between parties that want to exchange confidential information. Recent examples of KEMs include ML-KEM and HQC.
    • The new publication, Recommendations for Key-Encapsulation Mechanisms (NIST Special Publication 800-227), describes the basic definitions, properties and applications of KEMs and provides recommendations for implementing and using KEMs securely.
  • Cyberscoop reports,
    • “Two teenagers were arrested in the United Kingdom this week, accused of associating with the sprawling criminal collective known as The Com, and participating in many high-profile and damaging cyberattacks on critical infrastructure globally.
    • “Thalha Jubair, 19 of London, and Owen Flowers, 18 of Walsall, England, were arrested at their residences Tuesday and charged with crimes related to the cyberattack on the Transport for London in September 2024, the U.K.’s National Crime Agency said.
    • “Jubair and Flowers were allegedly highly involved in many other cyberattacks attributed to Scattered Spider, a nebulous offshoot of The Com that commits ransomware and data extortion. The Com is composed of thousands of members, splintered into three primary subsets of interconnected networks that commit swatting, extortion and sextortion of minors, violent crime and various other cybercrimes, according to the FBI.
    • “The Justice Department on Thursday unsealed charges against Jubair, a U.K. national, accusing him of participating in at least 120 cyberattacks as part of Scattered Spider’s sweeping extortion scheme from May 2022 to September 2025, including 47 U.S.-based organizations. Victims of those attacks paid at least $115 million in ransom payments, authorities said.”

From the cybersecurity vulnerabilities and breaches front,

  • While CISA did not add any known exploited vulnerabilities to its catalog this week, SC Media lets us know,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) on Sept. 18 issued a malware analysis report on two sets of malicious code from an organization compromised by threat actors exploiting two bugs in the Ivanti Endpoint Manager Mobile (EPMM) tool.
    • “CISA said the malware exploited two CVEs – CVE-2025-4427 and CVE-2025-4428. After exploitation, the malware let the threat actors inject and run arbitrary code on the compromised server.
    • “Lawrence Pingree, technical evangelist at Dispersive Holdings, said malware that’s instrumented to target specific vulnerabilities in centralized endpoint management solutions like these Ivanti tools is incredibly important to defend against.
    • “Isolating and microsegmenting sensitive systems like this is essential. Patching rapidly, ideally with an automated process, is essential in defending against vulnerabilities,” said Pingree.”
  • Per Dark Reading,
    • “Security vendor SonicWall suffered a data breach that exposed customer firewall configuration file backups.
    • “On Sept. 17, SonicWall, a vendor best known for its network security appliances, published a knowledge base article disclosing what it described as a “cloud backup file incident.” The company said its security teams recently detected “suspicious activity targeting the cloud backup service for firewalls” and confirmed it to be a security event in the past few days.
    • “Unidentified threat actors accessed backup firewall preference files stored in the cloud representing “fewer than 5% of our firewall install base,” according to SonicWall. Attackers were able to access encrypted credentials as well as firewall configuration files “that could make it easier for attackers to potentially exploit the related firewall.”
    • “We are not presently aware of these files being leaked online by threat actors,” SonicWall said in its disclosure. “This was not a ransomware or similar event for SonicWall, rather this was a series of brute force attacks aimed at gaining access to the preference files stored in backup for potential further use by threat actors.”
  • Per Cyberscoop,
    • “Researchers warned that a maximum-severity vulnerability affecting GoAnywhere MFT bears striking similarities with a widely exploited defect in the same file-transfer service two years ago.
    • “Fortra, the cybersecurity vendor behind the product, disclosed and released a patch for the vulnerability — CVE-2025-10035 — Thursday. The deserialization vulnerability “allows an actor with a validly forged license response signature to deserialize an arbitrary actor-controlled object, possibly leading to command injection,” the company said in a security advisory.
    • “File transfer services are a valuable target for attackers because they store a lot of sensitive data. If cybercriminals exploit these services, they can quickly access information from many users at once, making these services especially attractive for large-scale attacks. 
    • “Fortra didn’t provide any evidence of active exploitation and researchers from multiple security firms said they haven’t observed exploitation but expect that to change soon. “We believe that it’s just a matter of time and are monitoring the situation closely,” Ryan Dewhurst, head of proactive threat intelligence at watchTowr, said in an email.
    • “The vulnerability, which has a CVSS rating of 10, is “virtually identical to the description for CVE-2023-0669,” a zero-day vulnerability exploited by Clop, resulting in attacks on more than 100 organizations, and at least five other ransomware groups, Caitlin Condon, vice president of security research at VulnCheck, said in a blog post.”
  • and
    • “Apple’s latest operating systems for its most popular devices — iPhones, iPads and Macs — include patches for multiple vulnerabilities, but the company didn’t issue any warnings about active exploitation. 
    • “Apple patched 27 defects with the release of iOS 26 and iPadOS 26 and 77 vulnerabilities with the release of macOS 26, including some bugs that affected software across all three devices. Apple’s new operating systems, which are now numbered for the year of their release, were published Monday as the company prepares to ship new iPhones later this week.
    • “Users that don’t want to upgrade to the latest versions, which adopt a translucent design style Apple dubs “liquid glass,” can patch the most serious vulnerabilities by updating to iOS 18.7 and iPad 18.7 or macOS 15.7. Most Apple devices released in 2019 or earlier are not supported by the latest operating systems.
    • “None of the vulnerabilities Apple disclosed this week appear to be under active attack, Dustin Childs, head of threat awareness at Trend Micro’s Zero Day Initiative, told CyberScoop.”
  • Cybersecurity Dive points out,
    • “Most companies worry their networks aren’t safe against cyberattacks powered by artificial intelligence.
    • “Only 31% of IT leaders are at least somewhat confident that they can defend their organizations against AI-powered attacks, according to a Lenovo report published on Thursday.
    • “The report delves into why IT and security leaders are worried about hackers’ use of AI — and why they see their companies’ own use of AI systems as vulnerable.”
  • and
    • “The number of healthcare organizations that have lost more than $200,000 to cyberattacks has quadrupled this year compared with the same period in 2024, data security firm Netwrix said in a report published Thursday [September 19].
    • “Nearly half of all healthcare organizations (48%) experienced at least one intrusion between March 2024 and March 2025, the report found.
    • “Healthcare organizations experienced more cyberattack-related losses of at least $500,000 than critical infrastructure firms did, on average: 12% of healthcare organizations, compared with 6% of all organizations.”

From the ransomware front,

  • Infosecurity Magazine reports,
    • “Fifteen well-known ransomware groups, including Scattered SpiderShinyHunters and Lapsus$, have announced that they are shutting down their operations.
    • “The collective announcement was posted on Breachforums, where the groups claimed they had achieved their goals of exposing weaknesses in digital infrastructure rather than profiting through extortion.
    • “In their statement, the gangs said they would now shift to “silence,” with some members planning to retire on the money they had accumulated, while others would continue studying and improving the systems people rely on daily.” * * *
    • “Organizations should take these announcements with a pinch of salt,” Nivedita Murthy, senior staff consultant at Black Duck, said.
    • “It could be possible that some of these groups may have decided to step back and enjoy their payday, [but] it does not stop copycat groups from rising up and taking their place.”
  • IT Pro discusses the “top ransomware trends for businesses in 2025. A splintering of top groups and changing attitudes toward payments are changing attacker tactics at speed.”
  • Morphisec calls attention to “The Top Exploited Vulnerabilities Leading to Ransomware in 2025 — and How to Stay Ahead.” 

From the cybersecurity defenses front,

  • The American Hospital Association News reports,
    • “Microsoft Sept. 16 announced it had disrupted a growing phishing service that had targeted at least 20 U.S. health care organizations. The company said it used a court order granted by the U.S. District Court for the Southern District of New York to seize 338 websites associated with RaccoonO365, a cyber threat group known for stealing Microsoft 365 credentials through phishing tactics. RaccoonO365 offers subscription-based phishing kits that allow individuals to steal Microsoft credentials by mimicking official Microsoft communications. The company said the phishing kits use Microsoft branding to create fraudulent emails, attachments and websites. Since July 2024, the kits have stolen at least 5,000 Microsoft credentials from individuals in 94 countries. The group was recently observed offering a new artificial intelligence-powered service in an attempt to scale their operations.
    • “Credentials stolen through RaccoonO365 enabled ransomware attacks against hospitals, posing a direct threat to patient and community safety,” said John Riggi, AHA national advisor for cybersecurity and risk. “This operation also highlights a disturbing trend — cybercriminals’ increased use of ‘initial access brokers’ to steal credentials and AI to accelerate the effectiveness, sophistication and impact of cyberattacks. The need for continued and evolving social engineering training for staff is essential to defend against the latest deception tactics used by hackers.”
  • Cybersecurity Dive tells us,
    • “Preemptive cybersecurity solutions will account for about half of all IT security spending by the year 2030, a significant increase from its 5% share in 2024, Gartner said in a report published Thursday.
    • “Preemptive cybersecurity will effectively replace standard detection and response technologies as the preferred defense against malicious hacking, Gartner predicted.
    • “The technology uses artificial intelligence and machine learning to anticipate threats and then neutralize them before they can compromise their targets, according to researchers.”
  • Security Week reflects on the fifteen anniversary of the Zero Trust strategy.
    • “The implementation of zero trust is essential for cybersecurity: but after 15 years, we’re still not there. Implementation is like the curate’s egg: good in parts.
    • “Zero Trust turned fifteen years old on September 14, 2025. Its invention was announced with Forrester’s publication of John Kindervag’s paper, No More Chewy Centers: Introducing The Zero Trust Model of Information Security, on that date in 2010 (archived here).
    • “Zero trust recognizes that treating cybersecurity like an M&M (a hard crunchy shell impenetrable to hackers protecting a soft chewy center where staff can work freely and safely) simply doesn’t work. “Information security professionals must eliminate the soft chewy center by making security ubiquitous throughout the network, not just at the perimeter,” wrote Kindervag.
    • “This is the basis of zero trust (or ZT): abandon the old concept of a barrier between two separate networks (one untrusted: the internet; and one trusted: the enterprise). Instead, trust nothing and verify everything, regardless of source or destination. The concept is sound and rapidly gained approval, culminating in EO14028 mandating that federal agencies must move toward a zero trust architecture while private companies should do similar – but never defining how it could be achieved.
    • “There’s the rub. Zero trust is fundamentally a concept where implementation will depend on individual different corporate ecospheres.”
  • Dark Reading recommends “Transforming Cyber Frameworks to Take Control of Cyber-Risk.”
  • Here’s a link to Dark Reading’s CISO Corner.