FEHBlog

Monday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Generative AI, HSA, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Hill reports,
    • “President Trump said he is talking with Democrats about a direct health care payment plan Sunday amid negotiations to tackle rising health insurance premiums. 
    • “I’ve had personal talks with some Democrats,” Trump told reporters in West Palm Beach, Fla., on Sunday before returning to Washington. 
  • STAT News adds,
    • “Sen. Bill Cassidy (R-La.) is pitching Democrats on his compromise to make Affordable Care Act marketplace plans affordable without extending the extra tax credits that currently lower premium payments.
    • “Cassidy, the chair of the Senate health committee, is among the team of Republican senators picked to negotiate with Democrats on the credits in preparation for a mid-December vote. Republicans agreed to the vote in exchange for Democrats’ support to reopen the government. 
    • “Cassidy’s plan is not the official Republican plan, but he said his proposal is in line with the thinking of his GOP colleagues. Its structure jibes with President Trump’s demand to end the extra federal subsidies for ACA insurance and instead give an equal amount of cash directly to people to spend on health care. 
    • “The crux of Cassidy’s plan is to fund health savings accounts with money that currently goes toward the enhanced premium tax credits. His plan would not affect the original ACA premium tax credits. It would only apply to the extra, pandemic-era credits that expire at the end of the year. Cassidy described his plan to reporters during a briefing on Monday but has not yet released corresponding legislation.
    • “Cassidy’s proposal is for these HSAs to accompany ACA bronze plans. Trump’s tax bill changed the rules so that all bronze plans are eligible for HSAs, starting Jan. 1.
    • “Cassidy said he has not yet figured out how to allocate the HSA subsidies to enrollees, which could be complicated.
    • “Bronze plans have the lowest premiums among the three metal-tier plans and the highest cost sharing. Premiums vary significantly by state, but the average lowest monthly bronze plan premium is $456 and the average lowest silver premium is $611, before any subsidies, according to KFF.” 
  • Roll Call provides an overview of Congressional activities this week.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Nov. 14 released preliminary guidance to states on implementing provider tax provisions in the One Big Beautiful Bill Act. CMS clarified the meaning of “enacted” and “imposed” for purposes of section 71115, which establishes new indirect hold harmless thresholds effective Oct. 1, 2026. A tax is considered enacted when the legislative process authorizing the tax is fully completed and any required waiver is approved by CMS as of July 4, 2025. A tax is imposed when the state or locality was actively collecting revenue under that tax structure on the same date. These definitions establish that only taxes in effect as of July 4, 2025, are included in the new indirect hold harmless threshold, effectively prohibiting new or increased provider taxes beyond those limits. 
    • “CMS also addressed transition periods under section 71117, which specified circumstances in which a provider tax is not considered generally redistributive and therefore noncompliant. States with noncompliant managed care organization taxes approved before July 4, 2025, have until the end of their fiscal year ending in 2026 to comply, while other affected provider taxes have until the end of the fiscal year ending in 2028, but no later than Oct. 1, 2028. CMS emphasized that these transition periods are intended to allow states to prioritize compliance while maintaining Medicaid fiscal integrity and will be finalized through notice-and-comment rulemaking.” 
  • Federal News Network interviews an OPM official Holly Schumann and Consumer Checkbook’s director Kevin Moss about the ongoing Federal Benefits Open Season.
  • The Wall Street Journal informs us,
    • “The Federal Aviation Administration said it would lift its flight restrictions related to the government shutdown, clearing the way for normal operations to resume at U.S. airports after weeks of delays and cancellations. 
    • “Transportation Secretary Sean Duffy and FAA Administrator Bryan Bedford said Sunday that the 6% traffic cut implemented last week would be terminated at 6 a.m. ET Monday morning. They said the move came after the FAA reviewed safety trends and saw improving staffing levels.
    • “Now we can refocus our efforts on surging controller hiring and building the brand new, state of the art air-traffic control system the American people deserve,” Duffy said.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration has green-lit home use of a device that helps people with spinal cord injuries regain mobility and functioning. Onward Medical announced Monday that the company had received clearance to expand the use of its spinal cord stimulator outside of clinics.
    • “People living with [spinal cord injuries] will now be able to benefit from use of the ARC-EX System in the comfort and convenience of their own homes,” said CEO Dave Marver in a press release.”
  • Per Fierce Pharma,
    • “The clock is up on Biogen’s extra two years of a biosimilar-free U.S. market for its blockbuster multiple sclerosis (MS) med Tysabri. After waiting in the wings post-FDA approval in 2023, Sandoz’s biosimilar rival Tyruko has officially launched in the U.S.
    • “Tyruko is not only the first Tysabri biosimilar, but it’s also the first U.S. biosimilar that can treat multiple sclerosis. The launch marks an “important opportunity to help people with MS navigate this disease in a way that is more cost-effective,” Sandoz’s North America president Keren Haruvi explained in the company’s Nov. 17 press release. 
    • “Sandoz pinned its name on the drug through a global commercialization agreement with Polpharma Biologics in 2019, which developed Tyruko and handles manufacturing and supply. The biosimilar is also available in 14 European countries and is expected to be a “key contributor to the Sandoz growth strategy,” according to its release, fitting into the company’s ambitions to be “#1 in biosimilars in the US and a leader in the treatment of MS globally.”
  • Per MedTech Dive,
    • Zimmer Biomet said Friday [November 14] that it has received 510(k) clearance for an updated version of its Rosa knee surgery robot.
    • The Food and Drug Administration clearance covers Rosa Knee with Optimize. Compared to the older system, Zimmer has simplified the user interface and streamlined the surgical workflow.
    • Zimmer CEO Ivan Tornos predicted at investor events earlier this year that the new system would accelerate Rosa installs and be a “meaningful contributor” to sales in 2026.

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “A Washington state resident has contracted a bird flu strain previously only found in animals, health officials confirmed Nov. 14. 
    • “The individual has been hospitalized since early November with influenza H5N5, an avian influenza strain never before reported in humans, according to the Washington State Department of Health. The patient is an older adult with underlying health conditions who has a “mixed backyard flock of domestic poultry at home that had exposure to wild birds,” officials said, adding the animals likely exposed the virus to the individual but an investigation is ongoing. 
    • “The CDC said the risk to the public remains low. 
    • “As of Nov. 14, the CDC has confirmed 71 cases of human bird flu and one death. The most common strain in animals and humans is H5N1. Richard Webby, PhD, a virologist and influenza expert at St. Jude’s Children Research Hospital in Memphis, Tenn., told The Washington Post the H5N5 strain behaves similarly to H5N1 in models.” 
  • The American Medical Association lets us know what doctors wish older adults knew about physical activity.
    • “From aerobics to balance workouts for seniors, it’s key to find a physical activity that works as you age. Two Northwell Health physicians share more.”
  • Parkinsons News Today points out,
    • “Frequently eating sweets, red meat, and processed meats appears to increase the risk of developing Parkinson’s disease, while consuming more fruits — especially citrus — may be protective against it, according to a large study from Italy.
    • “The researchers found, however, that certain nondietary influences were more strongly linked to the risk of Parkinson’s than eating habits. Key among these, the team noted, were family history, digestive problems, and exposure to pesticides, oils, metals, and general anesthesia.
    • “This study suggests that eating habits might have some impact on [Parkinson’s disease], but they are not the main cause,” the scientists wrote. “Future research should look at both diet and other lifestyle habits to better understand how to prevent [Parkinson’s].”
    • “The study, “The impact of diet on Parkinson’s disease risk: A data-driven analysis in a large Italian case-control population,” was published in the Journal of Parkinson’s Disease.”
  • Per Health Day,
    • “Want to avoid migraines? Stick to your boring routine, a new study suggests.
    • “Any major disruption to a person’s daily routine — called a “surprisal” event — is strongly linked to a higher risk of a migraine attack within the next 12 to 24 hours, researchers reported Nov. 11 in JAMA Network Open.
    • “Too much food or drink, staying up late, a stressful incident, unexpected good or bad news or a severe mood swing could pose a “surprise” to the body, setting it up for a next-day migraine, researchers said.
    • “Incorporating measurement of surprisal into migraine forecasting tools could provide individuals with a more effective, personalized strategy for managing headache risk,” concluded the research team led by Dana Turner, an assistant professor of anesthesia, critical care and pain medicine at Harvard Medical School.
    • “In fact, the findings support a person-centered approach to treating a migraine “that moves beyond static lists of potential causes to account for the unpredictable and context-sensitive nature of daily life.”
  • Per Medscape,
    • “More than half of the people who stop using GLP-1 drugs regain at least some of the weight within a year, new real-world data showed.
    • “The new findings, from a large national claims database, “corroborate the clinical trial data that treatment discontinuation leads to weight recurrence. Optimizing and personalizing the approach toward treating obesity and maximizing gastrointestinal tolerability will maximize long-term use and long-term benefits of weight reduction,” study author Michael A. Weintraub, MD, an endocrinologist at New York University Langone Health, New York City, told Medscape Medical News.
    • “Weintraub reported the data on November 5, 2025, at Obesity Week 2025. “Treatment discontinuation leads to weight recurrence in clinical trials, but few real-world studies have evaluated this issue,” Weintraub said in his introduction.”
  • Medscape also shares insights about “Breakthrough Therapies in Chronic Kidney Disease.”
  • Genetic Engineering and BioTechnology News relates,
    • “The human papillomavirus (HPV) vaccine is a triumph of modern medicine—but it cannot eliminate an existing infection. Once HPV takes hold, no approved vaccines can stop its progression to cervical cancer, leaving surgery and chemotherapy as the main options. Researchers at Chiba University are working to change that with a nanogel nasal vaccine that shows promise in preclinical models.
    • “The study, led by associate professor Rika Nakahashi-Ouchida, MD, and Hiromi Mori of Chiba University Hospital, was published in Science Translational Medicine. The paper, titled “Cationic nanogel–based nasal therapeutic HPV vaccine prevents the development of cervical cancer,” describes a vaccine that activates local immune responses and slows tumor growth in animal models.
  • STAT News reports,
    • “The biotechnology firm Nuvalent said Monday that its drug for a genetically defined type of lung cancer shrank tumors in more than a quarter of patients whose disease had returned after trying other targeted medicines, and that the response endured in most of those people for at least a year.
    • “According to the company and an analyst who follows it, the results could mean that the medicine might be approved quickly and adopted by patients and doctors who might prefer it based on its efficacy and side effect profile to existing treatments for this type of lung cancer, which is caused by alterations in a gene called ALK (anaplastic lymphoma kinase).”
  • Per Fierce Pharma,
    • “Nearly three years after striking up a Zymeworks licensing pact with an eye on challenging the status quo in HER2-positive cancers, Jazz Pharmaceuticals is seeing its vision with Ziihera come into clearer focus.
    • “In a press release Monday, Jazz described a positive phase 3 readout as boosting its confidence that it has a HER2-targeted “agent-of-choice” for first-line patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction and esophagus.
    • “For a combination of Ziihera plus chemotherapy and BeOne Medicines’ Tevimbra, Jazz sees a “new standard of care” coming into form.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “UnitedHealth Group’s Optum Health and CVS Health’s Oak Street Health are struggling to adapt to the modified Medicare Advantage risk-adjustment system. 
    • “These healthcare delivery subsidiaries are renegotiating insurance contracts to offset dwindling Medicare Advantage revenue.
    • “Optum Health and Oak Street Health are disproportionately reliant on reimbursements from their parent companies’ insurance arms, UnitedHealthcare and Aetna.”
  • and
    • “GoodRx is the latest telehealth company to launch a subscription weight loss program.
    • “GoodRx’s subscription program will initially start at $39 per month before going up to $119 per month in February, the company said in a release.”
  • The American Medical Association News tells us,
    • “The AHA Nov. 17 released Fast Facts: Is My Hospital Rural, featuring updated information on the important role rural hospitals play in their communities, the people they serve and the challenges they face. The infographic features updated information on the important role rural hospitals play, the people they serve and the challenges they face. The infographic is being released before National Rural Health Day on Thursday, Nov. 20.”
  • Per MedTech Dive,
    • “Boston Scientific and Siemens Healthineers have partnered to develop and commercialize Siemens Healthineers’ next-generation intracardiac echocardiography catheter, the companies said Thursday.
    • “The new cardiac imaging catheter is intended for use in structural heart procedures, including standalone Watchman left atrial appendage closure, Farapulse pulsed field ablation, and the Farawatch approach combining PFA with the Watchman implant. 
    • “Boston Scientific expects the agreement to encourage adoption of its Watchman device by more sites, furthering growth of an already successful business. Boston Scientific will become the exclusive distributor of the Acunav 4D ICE catheter in the U.S. and Japan, once the device is commercially available.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Health tech investor the SymphonyAI Group aims to leverage the best of both companies’ AI expertise to expand its reach among health systems.
    • “RhythmX AI and Get Well, two companies under the SAI Group’s banner, have merged to form GW RhythmX, the investor announced last week. The combined company already has broad reach in the healthcare market. It currently serves 150 health systems, SAI Group said in a press release.
    • “The companies’ combined capabilities will engage patients and help them navigate the healthcare system, while delivering personalized insights to physicians at the point of care, according to the investor in a press release.
    • “The former standalone company RhythmX AI is a personalized care platform that supports physician decision-making and boosts physician productivity by providing AI-powered care recommendations tailored to the patient. The platform also helps proactively manage patient care by identifying at-risk patients and projecting disease progression. It also routes patients to the right clinician at the right time.” 
  • Beckers Health IT informs us,
    • “Patients are increasingly turning to AI chatbots for health information, driven by long wait times, high healthcare costs and dissatisfaction with clinical interactions, The New York Times reported Nov. 16.
    • “About 17% of adults said they use AI chatbots at least once a month for health information and advice, according to a 2024 KFF poll. This figure increased to 25% among adults under age 30. 
    • “The Times interviewed dozens of patients about their chatbot use, many of whom reported the technology as a more responsive and accessible alternative to their physicians.” * * *
    • “While chatbots can help improve patients’ health literacy and access to timely information, researchers warn that the tools can generate incorrect, overly confident or clinically unsafe advice.
    • “A preprint study from Oxford University found that users rarely made a correct diagnosis or identified appropriate next steps when using ChatGPT to assess symptoms. The study has not yet been peer reviewed.” 

Weekend update

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medicare, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services (CMS) hosted health tech leaders at a Health Tech Ecosystem Connectathon event in Washington, D.C., Thursday [November 13, 2025] to showcase progress on its interoperability pledge.
    • “In late July, the CMS and the White House jointly announced a new focus on driving healthcare interoperability and getting health data into Medicare patients’ hands. The push for innovative products that ease health data transfer stems not from regulation, but from voluntary commitments made by industry to uphold new standards set out by the CMS. 
    • “The announcement was sprawling and included several spokes: a new CMS Interoperability Framework and a Health Tech Ecosystem that committed to working on conversational AI, modern digital identity verification and diabetes apps. 
    • “The CMS also committed to improving Medicare beneficiaries’ digital experience with CMS websites.” * * *
    • “The CMS debuted a beta prototype of its new national provider directory, multiple attendees said. The directory will allow Medicare beneficiaries to find providers that accept Medicare and will be available via a free FHIR API. 
    • “One participant noted that the CMS will update the public on its progress online and via a GitHub repository, an open-access cloud repository for projects that also tracks changes.  
    • Multiple companies also demonstrated products that meet the standards set out by the CMS in July for its so-called CMS Aligned Networks.”
  • Federal News Network shares OPM Associate Director for Healthcare and Insurance Shane Stevens views on the Open Season and the FEHB / PSHB program generally.

From the public health and medical / healthcare research front,

  • The Wall Street Journal offers women information about the Food and Drug Administration’s recent removal of a black box warning from all forms of menopausal hormone therapy.
  • Wired reports,
    • “GLP-1s are being studied for a wide range of conditions. Now, scientists will test whether their anti-inflammatory properties can help alleviate symptoms of long Covid.”
  • and
    • “The Aedes aegypti mosquito that can carry dengue, yellow fever, and Zika was thought to be too reliant on a hot and wet climate to survive in the Mountain West. But now, a population is thriving in Western Colorado.
  • The Washington Post adds,
    • “When Susan Akin first started injecting a coveted weight-loss drug early this year, the chaos in her brain quieted. The relentless cravings subsided — only they’d never been for food.
    • “The medication instead dulled her urges for the cocaine and alcohol that caused her to plow her car into a tree, spiral into psychosis and wind up admitted to a high-end addiction treatment center in Delray Beach, Florida.
    • “Doctors at Caron Treatment Centers tried a novel approach for the slender 41-year-old by prescribing her Zepbound, part of a blockbuster class of obesity and diabetes medications known as GLP-1s. Federal regulators have not approved the drugs for behavioral health, but doctors are already prescribing them off-label, encouraged by studies suggesting that they could reshape addiction treatment.
    • “Scientists caution that the research remains nascent. Health insurers do not cover the pricey drugs for that purpose. Addiction specialists say the medications might not be a cure but may work as a tool to quell addictive behaviors.”
  • MedPage Today informs us,
    • “Blood Test May Be a ‘Viable Alternative’ in Liver Cancer Surveillance. Investigational multi-target test more sensitive than ultrasound, but fell short in specificity.
  • The New York Times points out the best foods and drinks to resolve constipation.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health’s operations saw year-over-year improvement for the quarter ended September 30, but the nonprofit health system continues to be weighed down by rising expenses and reimbursement challenges.
    • “Despite strong volume, salary cost management, length-of-stay improvements and higher productivity, CommonSpirit’s financial performance continues to be impacted by expenses growing at a faster pace than revenue,” management said in a press release issued Friday.
    • “A significant impact to the organization’s revenue comes in the form of challenges with payers on denials and timely payments, and payment increases from both government and non-government payers that do not keep up with inflation,” management said.
    • “The 138-hospital system reported an as-recorded operating loss of $396 million (-4.0% operating margin) for the quarter ended September 30, its first fiscal quarter in 2026, as compared to the prior year’s $331 million operating loss (-3.5% operating margin).”
  • and
    • “Maven Clinic is expanding its maternity program to make pregnancy care more precise and personalized.
    • “The expansion includes remote monitoring to identify risks earlier and help address complications. Maven is also adding a NICU program to help get babies home faster through parent preparedness. New features begin rolling out this month.
    • “There’s no typical pregnancy; it’s not a thing. And it’s 2025, and it’s time to not have a cookie-cutter approach,” Neel Shah, M.D., chief medical officer at Maven, told Fierce Healthcare in an advanced interview.
    • “Maven clients trust the company to take care of an entire population, per Shah. That requires providing the right care for the right person, which is now being enabled by a new level of access to data. A year ago, Maven still relied on what members shared about themselves and claims data, Shah said. Now, Maven also has insights from wearables.”
  • Per a November 11, 2025, company news release,
    • “Doc.com, a pioneering healthcare technology company, proudly announces the launch of its new telemedicine platform and services. The platform combines artificial intelligence and blockchain-based technologies to enhance patient access, data security, and care coordination. Through a seamless mobile experience, patients can connect with licensed healthcare professionals within their state to receive quality care conveniently and securely. As part of its introductory rollout, new users may access up to 15 minutes of complimentary teleconsultation, available in eligible jurisdictions and subject to applicable regulations. These minutes may be used across one or multiple sessions as part of an initial trial experience. Subsequent consultations will be available at standard rates.
    • “Doc.com’s United States application rollout begins today with Phase 1 launching in West Virginia, followed by Virginia soon after. The company will then expand to the remaining U.S. states in three additional phases throughout 2026, concluding with full nationwide availability by early 2027. In addition to its United States rollout, Doc.com is introducing a blockchain component, designed to ensure secure, transparent, and efficient transactions across the healthcare ecosystem. This technology supports telemedicine consultations, medical record management, and AI-driven diagnostics, creating a fully integrated platform.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cybersecurity Dive reports,
    • “Congress has temporarily reauthorized a vital but recently expired cybersecurity law as part of a bill to reopen the federal government and end the longest shutdown in U.S. history.
    • “The spending legislation, which passed the House and received President Donald Trump’s signature on Wednesday [November 12, 2025] after passing the Senate on Monday [November 10, 2025], will revive the 2015 Cybersecurity Information Sharing Act through Jan. 30, 2026, giving Congress roughly two months to agree on a longer-term plan for the law.
    • “CISA 2015, as the program is known, gave companies liability protections for sharing indicators of cyber threats with federal agencies and one another. The law’s expiration on Sept. 30 has alarmed federal officials, industry executives and cyber experts who say the government may now be receiving less information about cyberattacks from businesses afraid of the legal risks.”
  • Security Week tells us,
    • “The US Department of Defense’s long-anticipated Cybersecurity Maturity Model Certification (CMMC) program officially entered its enforcement phase on November 10, 2025.
    • “Introduced as an amendment to the Defense Federal Acquisition Regulation Supplement (DFARS), the CMMC program requires defense contractors and subcontractors to implement specific cybersecurity measures to protect sensitive information. 
    • “The Department of Defense, also referred to as the Department of War, can now mandate CMMC compliance as a condition for new defense industrial base (DIB) contracts.
    • “The goal is to ensure that contractors and subcontractors can protect Federal Contract Information (FCI) and Controlled Unclassified Information (CUI). FCI is information not intended for public release that is provided to or generated by a contractor. CUI is sensitive government information that is not classified but still requires protection from unauthorized disclosures.
    • “For the past eight years, contractors have been allowed to self-attest to cybersecurity compliance, but now some organizations will also need to undergo a formal assessment by a certified third-party assessor organization (C3PAO).”
  • [On November 14, 2025,] [t]he HHS Office of Inspector General issued a report to the National Institutes of Health about necessary steps to improve the cybersecurity of the All of Us Research Program to protect participant data.
  • Bleeping Computer informs us,
    • “The U.S. Department of Justice announced [on November 14, 2025] that five individuals pleaded guilty to aiding North Korea’s illicit revenue generation schemes, including remote IT worker fraud and cryptocurrency theft.
    • “As part of this, the U.S. authorities announced actions seeking the forfeiture of $15 million in cryptocurrency from heists carried out by the APT38 threat group, which is linked to the Lazarus hacking group.
    • “The facilitators, four Americans and one Ukrainian, used their own, false, or stolen (from 18 U.S. persons) identities to make it possible for DPRK agents to be hired by American firms for remote work.
    • “The latter then funneled their salaries, as well as, in some cases, stolen data, to the North Korean government.
    • “According to the DOJ’s announcement, the actions of the five individuals affected 136 companies nationwide and generated over $2.2 million in revenue for the DPRK regime.”
  • Cybersecurity Dive points out,
    • “The U.S. and eight other Western governments have jointly dismantled the computer infrastructure behind multiple popular cybercrime tools.
    • “In a three-day operation [announced on November 14, 2025], law enforcement authorities took down more than 1,000 servers and 20 domains associated with the Rhadamanthys infostealer, the VenomRAT remote access Trojan and the Elysium botnet. Greek police arrested VenomRAT’s suspected operator.
    • “The dismantled malware infrastructure consisted of hundreds of thousands of infected computers containing several million stolen credentials,” Europol, which coordinated the operation from its headquarters in The Hague, said in a statement. “The main suspect behind the [Rhadamanthys] infostealer had access to over 100,000 crypto wallets belonging to these victims, potentially worth millions of euros.”
    • “Australia, Canada, Denmark, France, Germany, Greece, Lithuania, the Netherlands and the U.S. participated in the takedowns, which were the latest phase of Operation Endgame, an ongoing multinational effort to cripple cybercrime gangs. Cybersecurity firms, telecom companies and independent research organizations, including CrowdStrike, Lumen and Shadowserver, provided support for the operation.
    • The law enforcement disruptions targeted infrastructure that Europol said “played a key role in international cybercrime.”

From the cybersecurity breaches and vulnerabilities front,

  • The Wall Street Journal reports,
    • “China’s state-sponsored hackers used artificial-intelligence technology from Anthropic to automate break-ins of major corporations and foreign governments during a September hacking campaign, the company said Thursday [November 13, 2025].
    • “The effort focused on dozens of targets and involved a level of automation that Anthropic’s cybersecurity investigators had not previously seen, according to Jacob Klein, the company’s head of threat intelligence.
    • “Hackers have been using AI for years now to conduct individual tasks such as crafting phishing emails or scanning the internet for vulnerable systems, but in this instance 80% to 90% of the attack was automated, with humans only intervening in a handful of decision points, Klein said.
    • “The hackers conducted their attacks “literally with the click of a button, and then with minimal human interaction,” Klein said. Anthropic disrupted the campaigns and blocked the hackers’ accounts, but not before as many as four intrusions were successful. In one case, the hackers directed Anthropic’s Claude AI tools to query internal databases and extract data independently.
    • “The human was only involved in a few critical chokepoints, saying, ‘Yes, continue,’ ‘Don’t continue,’ ‘Thank you for this information,’ ‘Oh, that doesn’t look right, Claude, are you sure?’ ”
    • “Stitching together hacking tasks into nearly autonomous attacks is a new step in a growing trend of automation that is giving hackers additional scale and speed.” 
  • Cybersecurity Dive adds,
    • “More than 80% of workers, including nearly 90% of security professionals, use unapproved AI tools in their jobs, according to a new report from the cyber risk monitoring vendor UpGuard.
    • “This unapproved AI use, which can introduce security vulnerabilities, is not just widespread but pervasive, with half of workers saying they use unapproved AI tools regularly and less than 20% saying they use only company-approved AI tools.
    • ‘Security leaders were more likely than the average employee to report using unapproved tools and far more likely to say they did so regularly, according to the report.”
  • Cybersecurity Dive adds,
    • “An advanced persistent threat actor has been targeting zero-day vulnerabilities in Cisco Identity Service Engine as well as Citrix, according to a blog post published Wednesday [November 12, 2025] by security researchers at Amazon.”
  • Per Tech Radar,
    • “Digital privacy is a growing concern these days, with millions turning to virtual private networks to shield their online activity.
    • “However, in a stark new warning, Google has confirmed that cybercriminals are exploiting this need for security by distributing malicious applications disguised as legitimate VPN services. This creates a dangerous situation where a tool meant to be a shield is, in fact, a weapon used to steal sensitive user data.
    • “The alert was issued as part of Google’s November 2025 fraud and scams advisory, which details the latest trends in online threats. Alongside warnings about AI-driven job scams and holiday-themed phishing schemes, the advisory specifically calls out the danger of fraudulent VPN apps and browser extensions.”
  • An ISACA commentator explains why more cyber tools can make you less secure.
    • “On his deathbed, the actor Edmund Kean famously said, “Dying is easy. Comedy is hard.”  Here’s my version for cybersecurity professionals: Buying is easy. Operating is hard.
    • “It all comes down to the unglamorous, disciplined work of process, by which I mean configuration, testing, documentation and ownership. That’s what creates resilience. No, that work doesn’t photograph well, and it doesn’t come with a vendor logo. But it’s the difference between a security program and a shopping list.
    • “Buying a tool gives you the illusion of safety. Running it well gives you the reality. My advice? Choose reality. Everything else is marketing.”

From the ransomware front,

  • Cyberscoop reports,
    • “Federal cyber authorities shared new details Thursday about the Akira ransomware group’s techniques, the tools it uses and vulnerabilities it exploits for initial access alongside the release of a joint cybersecurity advisory.
    • “Members of the financially motivated group, which initially appeared in March 2023, are associated with other threat groups, including Storm-1567, Howling Scorpius, Punk Spider, Gold Sahara, and may have connections with the disbanded Conti ransomware group, officials said. Akira uses a double-extortion model, encrypting systems after stealing data to amplify pressure on victims.
    • “Akira ransomware has claimed more than $244 million in ransomware proceeds as of late September, the FBI and Cybersecurity and Infrastructure Security agency said in the joint advisory. The group primarily targets small- and medium-sized businesses with many victims impacted in the manufacturing, education, IT, health care, financial and agriculture sectors.
    • “For the FBI, it is within the top five variants that we investigate,” Brett Leatherman, assistant director at the FBI Cyber Division, said during a media briefing Thursday. “It’s consequential. This group is very consequential that they fall likely within our top five.” * * *
    • “The joint advisory, which updates previous guidance around hunting for and defending against Akira, was not in response to any specific attack, said Nick Andersen, executive assistant director for cybersecurity at CISA.” 
  • and
    • “The Washington Post said it, too, was impacted by the data theft and extortion campaign targeting Oracle E-Business Suite customers, compromising human resources data on nearly 10,000 current and former employees and contractors.
    • “The company was first alerted to the attack and launched an investigation when a “bad actor” contacted the media company Sept. 29 claiming they gained access to the company’s Oracle applications, according to a data breach notification it filed in Maine Wednesday. The Washington Post later determined the attacker had access to its Oracle environment from July 10 to Aug. 22. 
    • “The newspaper is among dozens of Oracle customers targeted by the Clop ransomware group, which exploited a zero-day vulnerability affecting Oracle E-Business Suite to steal heaps of data. Other confirmed victims include Envoy Air and GlobalLogic.”
  • Bleeping Computer adds,
    • “Hardware accessory giant Logitech has confirmed it suffered a data breach in a cyberattack claimed by the Clop extortion gang, which conducted Oracle E-Business Suite data theft attacks in July.
    • “Logitech International S.A. is a Swiss multinational electronics company that sells hardware and software solutions, including computer peripherals, gaming, video collaboration, music, and smart home products.
    • “Today [November 14, 2025], Logitech filed a Form 8-K with the U.S. Securities and Exchange Commission, confirming that data was stolen in a breach.”
  • The Hacker News relates
    • 85 active ransomware and extortion groups observed in Q3 2025, reflecting the most decentralized ransomware ecosystem to date.
    • 1,590 victims disclosed across 85 leak sites, showing high, sustained activity despite law-enforcement pressure.
    • 14 new ransomware brands launched this quarter, proving how quickly affiliates reconstitute after takedowns.
    • LockBit’s reappearance with version 5.0 signals potential re-centralization after months of fragmentation.
  • Security Boulevard offers zero trust insights from the Ingram Micro ransomware attack.
    • “The Ingram Micro ransomware attack serves as a potent reminder that credential theft and internal propagation can cripple even the most robust enterprises. When attackers move freely within a trusted environment, it’s not just the perimeter that’s at risk. It’s every file, every system, and every partner connected to the network. The lesson is clear: true prevention requires more than detection or containment. It demands a mindset where every file, from every source, is verified safe before it’s allowed to move between channels, endpoints, and users.”

From the cybersecurity defenses front,

  • Healthcare Dive offers tips to improve healthcare system cybersecurity.
    • “Healthcare organizations should invest in post-attack recovery and carefully evaluate risks from vendors, according to industry experts who spoke at a Healthcare Dive virtual event.”
  • Cyberscoop reports,
    • “The phishing kit Lighthouse, which has aided text scams like those soliciting victims to pay unpaid road tolls, appears to have been hampered shortly after Google filed a lawsuit aimed at its creators.
    • “Google said on Thursday [November 13, 2025] that Lighthouse had been shut down. Two other organizations that have tracked the suspected Chinese operators of Lighthouse said they saw signs it had at least been disrupted.
    • “This shut down of Lighthouse’s operations is a win for everyone,” said Halimah DeLaine Prado, general counsel at Google. “We will continue to hold malicious scammers accountable and protect consumers.”
    • “Google filed its lawsuit in the U.S. District Court for the Southern District of New York. They allege that 25 unnamed individuals behind Lighthouse have violated racketeering, trademark and anti-hacking laws with their prolific SMS phishing, or “smishing,” platform.”
  • Bleeping Computer lets us know,
    • “Fortinet has confirmed that it has silently patched a critical zero-day vulnerability in its FortiWeb web application firewall, which is now “massively exploited in the wild.”
    • “The flaw was silently patched after reports that unauthenticated attackers were exploiting an unknown FortiWeb path traversal flaw in early October to create new administrative users on Internet-exposed devices.
    • “The attacks were first identified by threat intel firm Defused on October 6, which published a proof-of-concept exploit and reported that an “unknown Fortinet exploit (possibly a CVE-2022-40684 variant)” is being used to send HTTP POST requests to the /api/v2.0/cmdb/system/admin%3f/../../../../../cgi-bin/fwbcgi Fortinet endpoint to create local admin-level accounts.”
  • Cybersecurity Dive informs us,
    • “Businesses face a range of problems with their threat intelligence platforms, including difficulty assessing the accuracy of alerts and problems integrating the platforms with their existing tools, according to a report that Recorded Future published on Wednesday.
    • “The report, which assessed the state of threat intelligence in enterprises, found that 83% of companies have dedicated threat intelligence teams, a slight uptick from last year.
    • “Roughly half of companies (48%) pay for more than one threat intelligence service, while 41% pay for only one.”
  • Dark Reading relates,
    • “New survey data indicates that organizations are pushing hard for passwordless authentication.
    • “A significant chunk of online account passwords in 2025 remain basic and easy to crack — a fact that will surprise few. But last month, Dark Reading asked readers how their organizations are handling password security these days. The results were, perhaps surprisingly, optimistic.
    • “As we enter the second quarter of the 21st century, rather than applying new Band-Aids to the problem, organizations finally appear to be moving toward a future with few to no passwords at all.”
  • Dark Reading offers insights into Apple / Mac security tools.
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor reflects on the shutdown in his Secrets of OPM blog.
  • CMS announced 2026 Medicare Parts A & B Premiums and Deductibles and 2026 Medicare Part D Income-Related Monthly Adjustment Amounts. Of note,
    • “The standard monthly premium for Medicare Part B enrollees will be $202.90 for 2026, an increase of $17.90 from $185.00 in 2025. The annual deductible for all Medicare Part B beneficiaries will be $283 in 2026, an increase of $26 from the annual deductible of $257 in 2025. 
    • “The increase in the 2026 Part B standard premium and deductible is mainly due to projected price changes and assumed utilization increases that are consistent with historical experience. If the Trump Administration had not taken action to address unprecedented spending on skin substitutes, the Part B premium increase would have been about $11 more a month. However, due to changes finalized in the 2026 Physician Fee Schedule Final Rule, spending on skin substitutes is expected to drop by 90% without affecting patient care.”
  • Federal News Network reports,
    • “The Postal Service is seeing deeper financial losses than expected this year, but does not expect to veer much from a 10-year reform plan that it is nearly midway through completing.
    • “USPS, however, is far from the plan’s “break-even” goal, and is calling on Congress and the Trump administration to take a familiar wish list of reform efforts that are outside the agency’s control.
    • “The agency saw a $9 billion net loss in fiscal 2025 — significantly higher than the nearly $7 billion net loss it expected.
    • “USPS said it saw increased compensation costs, including offering early retirement incentives to more than 10,000 of its employees, which contributed to higher operating expenses this year.”
  • and
    • “More than 30,000 federal insurance enrollees may be in for some sticker shock next year, if they choose to do nothing during Open Season.
    • “With eight plan options being discontinued in the Federal Employees Health Benefits (FEHB) program, participants currently enrolled with those carriers — most of whom are enrolled in plans from the National Association of Letter Carriers — will, in some cases, face more than a 200% spike in premium costs, if they accept the auto-enrollment plan option for 2026.
    • “Typically, participants whose plans leave the FEHB program are automatically enrolled in the lowest-cost nationwide plan the following year. But for 2026, the Office of Personnel Management chose a different path forward.
    • “The specifics behind OPM’s decision remain unclear, but an OPM spokesperson told Federal News Network the agency chose a plan that’s not the lowest-cost nationwide plan “because we determined it was in the best interest of the program to do so.” * * *
    • “For 2026, the lowest cost nationwide plan that fits the statutory requirements is GEHA Elevate. But OPM made the decision to “exercise its authority” to make GEHA High the auto-enrollment plan instead.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “Withings, a French medtech company, has received U.S. Food and Drug Administration (FDA) clearance for BeamO, a new artificial intelligence (AI)-enabled device it describes as the “thermometer of the future.” BeamO includes electrocardiogram sensors, a stethoscope and a thermometer, providing users with a single check-up tool that evaluates a body temperature, cardiac health and pulmonary health in less than one minute—all from the comfort of home.
    • “BeamO is equipped with highly innovative sensors, meeting the challenge of miniaturization to bring together so many functionalities in such a small device,” Xavier Debreuil, product research director at Withings, said in a statement. “These sensors record the heart’s electrical activity as well as measure infrared light to interpret body temperature. On the other hand, they capture acoustic waves to study the activity of the heart and lungs. All the data is analyzed by artificial intelligence algorithms to identify anomalies.”
    • “BeamO brings access to key vital signs, typically measured during medical consultations, into everyday life,” added Eric Carreel, founder and president of Withings. “All this new data on the heart, lungs, and temperature provides an overview of the state of each user’s health. This data promotes a much more precise and reliable diagnosis, and it marks a revolution in telemedicine, transforming it into a true medical consultation by integrating the data collection component.”
    • “With FDA clearance now secured, BeamO is officially for sale in the United States. The price is $249.95. 
    • ‘By early 2026, the new-look thermometer will be available on Amazon and a variety of other retail partners.” 
  • Per Fierce Pharma,
    • “As Roche works to switch certain patients with breast cancer over to a fixed-dose combination of two medicines, its 13-year-old drug Perjeta is inching toward the end of its exclusive run in the U.S.
    • “The FDA said Thursday that it has approved Poherdy as an interchangeable biosimilar to Perjeta. The agency’s endorsement covers the Roche drug’s existing HER2-positive breast cancer indications. 
    • “Perjeta’s label currently includes its use in combination with trastuzumab and chemo for first-line HER2-positive metastatic breast cancer and as a neoadjuvant or adjuvant treatment for early-stage disease.”
  • and
    • “The FDA has officially limited the label of Sarepta Therapeutics’ Elevidys, putting an end to a whirlwind few months that saw the abrupt departure—and reinstatement—of top agency official Vinay Prasad, M.D.
    • “Duchenne muscular dystrophy (DMD) patients who are no longer able to walk independently can no longer receive the one-time gene therapy, the FDA said Friday. In addition, the drug’s indication now only covers ambulatory DMD patients who are at least 4 years of age.
    • “The official label restriction comes five months after Sarepta and its ex-U.S. partner Roche voluntarily suspended giving Elevidys to non-ambulatory patients following the report of a second recipient who died after developing acute liver failure.
    • “The updated label now includes a new boxed warning, the FDA’s most serious safety warning, describing the potentially deadly risks of serious liver injury and acute liver failure.”

From the judicial front,

  • The New York Times reports,
    • “The drugmaker Purdue Pharma, which along with its owners came to symbolize greedy indifference to surging opioid overdose deaths, will soon cease to exist, after a bankruptcy judge said Friday that he would give final approval to a plan to settle thousands of lawsuits against the company.
    • “The agreement comes more than two decades after the first legal actions were filed against Purdue over its aggressive sales tactics and promotion of the opioid painkiller OxyContin as largely nonaddictive. It requires members of the billionaire Sackler family to relinquish ownership of the company and pay as much as $7 billion over 15 years to states, communities, tribes and others harmed in what became a decades-long national opioid addiction crisis.
    • “I will tell you now that I’m going to confirm the plan,” Judge Sean H. Lane of the United States Bankruptcy Court for the Southern District of New York said Friday afternoon at the conclusion of three days of testimony. He said he would issue a formal ruling on Tuesday.
    • “Purdue will immediately contribute $900 million and then be dissolved. It will be reborn as a public benefit company called Knoa Pharma, which will manufacture limited quantities of opioid painkillers and also opioid overdose-reversal medications. Profits will go to programs to remediate the continuing devastation related to opioids.”

From the public health and medical / Rx research front,

  • Guess what’s back now that the shutdown is over? The Centers for Disease Control and Prevention announced today,
  • Beckers Hospital Review identifies the hospitals that received the best and the worst patient safety grades from the LeapFrog Group this week.
  • CNN Health tells us,
    • “As colon and rectal cancers in young people are on the rise globally, especially in the United States, consumption of ultraprocessed foods has been in lockstep. The fare now makes up roughly 70% of the US food supply and nearly 60% of US adult caloric intake, and several studies have linked this growing trend with the risk of such cancers.
    • “A new, first-of-its-kind study adds to the growing evidence by suggesting eating ultraprocessed foods may significantly raise the odds of developing early-age noncancerous colorectal adenomas — growths, or polyps, in the colon and rectum that can lead to cancer.”
    • “In the new study, ultraprocessed food intake was primarily from ultraprocessed breads and breakfast foods; sauces, spreads and condiments; and sugar- or artificially sweetened beverages.
    • “Participants with the highest intake of ultraprocessed foods — about 10 servings daily — had a 45% higher risk of developing those growths by age 50 when compared with those with the lowest consumption, a bit over three servings daily. The study, which followed more than 29,100 female nurses for a median period of 13 years, published Thursday in the journal JAMA Oncology.”
  • NBC News points out,
    • “One of the most common viruses in the world could be the cause of lupus, an autoimmune disease with wide-ranging symptoms, according to a study published Wednesday.
    • “Until now, lupus was somewhat mysterious: No single root cause of the disease had been found, and while there is no cure, there are medications that can treat it.
    • “The research, published in the journal Science Translational Medicine, suggests that Epstein-Barr virus — which 95% of people acquire at some point in life — could cause lupus by driving the body to attack its own healthy cells.
    • “It adds to mounting evidence that Epstein-Barr is associated with multiple long-term health issues, including other autoimmune conditions. As this evidence stacks up, scientists have accelerated calls for a vaccine that targets the virus.”
  • MedPage Today adds,
    • “Low levels of vitamin D and its principal circulating form 25-hydroxyvitamin D (25-OH-D) have been linked to many types of adverse outcomes beyond bone health, such as cardiovascular disease.
    • “How vitamin D levels may affect outcomes in lupus patients has not been well studied, especially over the long term.
    • “This prospective cohort study, with many years of follow-up, showed markedly increased risk for all-cause mortality and cardiovascular events in lupus patients with low levels at enrollment.”
  • Per Health Day,
    • “People facing a major surgery might understandably think they need to conserve their energy, both for the procedure as well as the rehabilitation to follow.
    • “But they’d be better off if they engaged in “prehabilitation.” And a new study found prehab works best if a patient receives some one-on-one attention.
    • “Patients who got a personalized prehab program with twice-weekly coaching wound up better prepped for surgery than those offered standard pre-surgery advice without any direct guidance, researchers reported Nov. 12 in the journal JAMA Surgery.
    • “Those who got personal coaching improved significantly on every test of physical and mental fitness prior to their procedure, researchers found.
    • “The patients also experienced changes in their immune system that aided their post-surgery recovery and wound up with fewer major complications.”
  • Per Medscape,
    • “The first global randomized trial of the PCSK9 inhibitor evolocumab for the prevention of a primary major adverse cardiovascular event (MACE) found a relative reduction in risk similar in magnitude to that previously seen for secondary prevention. 
    • “The VESALIUS-CV trial showed a risk reduction over a median of 4.6 years of follow-up of 19% and 25% (P < .001 for both) for the dual composite primary MACE endpoints. These were accompanied by a 20% reduction (P = .0005) in all-cause death, a result characterized as “nominal” because it was not among the prespecified composite endpoints.
    • “The reduction in MACE in this trial supports intensive LDL-C lowering in high-risk patients whether or not they have had a prior event,” said Erin A. Bohula, MD, DPhil, an associate physician in cardiovascular medicine at Brigham and Women’s Hospital in Boston, who led the study.
    • “The findings were presented at the 2025 Scientific Sessions of the American Heart Association and published simultaneously in The New England Journal of Medicine.”
  • Per MedPage Today,
    • “In patients with angina but no obstructive arteries on angiography, further testing with stress cardiac MRI improved diagnosing the cause of angina, resulting in better management and quality of life, the CorCMR trial showed.
    • “Reclassification of the initial angiogram-based diagnosis occurred in 53% of patients after cardiac MRI (95% CI 46.6-59.3, P<0.001), meeting the primary outcome of the diagnostic phase of the study, reported Colin Berry, MBChB, PhD, of the University of Glasgow in Scotland, at the American Heart Association (AHA)opens in a new tab or window annual meeting.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb and Johnson and Johnson have stopped early the first of trio of late-stage trials testing an experimental anticoagulant they hope will become a future blockbuster. 
    • “Trial monitors determined that a regimen involving the drug, milvexian, and standard medications wasn’t likely to be superior to those typical treatments alone at preventing cardiovascular complications in people who’d recently had a heart attack. Despite the failure, the two companies noted that two other large studies are ongoing and milvexian still has “multibillion-dollar potential.” 
    • “Still, the result is the latest setback for drugs in milvexian’s class, called Factor XIa inhibitors and viewed as potentially safer alternatives to widely used medicines like Eliquis and Xarelto. It’s also another recent negative readout for Bristol Myers, which has reported late-stage stumbles for drugs in cancer, mental health conditions and other diseases this year.” 

From the U.S. healthcare business front,

  • Kaufman Hall reports,
    • “The number of physicians exiting traditional Medicare has accelerated, especially since the Covid-19 pandemic, with the annual exit rate climbing from less than 1% in 2013 to nearly 5% in 2023, a new JAMA study has found. The study, a review of Medicare fee-for-service claims data, found that while the total number of physicians in fee-for-service Medicare rose modestly over the decade, from about 586,000 to 622,000, departures have accelerated sharply in recent years. Participation peaked in 2019, then began a steady decline that has continued. Researchers found higher exit rates among older doctors, women, primary care physicians and those practicing in rural or underserved areas but stopped short of making a claim about the impact of the pandemic. The trend raises concern that access to care for Medicare beneficiaries could erode even as the overall physician workforce grows; these patterns could exacerbate existing access gaps for older and rural Americans.”
  • The American Hospital Association News lets us know,
    • Aetna’s new “level of severity inpatient payment” policy is now set to take effect Jan. 1, 2026, the company recently announced, along with providing additional details about the policy. The policy was supposed to take effect Nov. 15. 
    •  Aetna earlier this year said it was creating a new type of inpatient reimbursement for so-called “low severity” inpatient stays that it has said will be “comparable” to observation rates. This policy will take the place of Aetna’s (and essentially every other insurer’s) long-standing approach of denying inpatient stays it deems medically unnecessary and then, in most instances, downgrading them to outpatient observation status. Instead, Aetna will approve these inpatient stays but reimburse hospitals at a lower rate it determined unilaterally outside of the good faith contract and rate negotiation process. This policy only will apply to Aetna’s Medicare Advantage and dual eligible lines of business. 
    •  In its Nov. 6 announcement, Aetna clarified that:
      • The level of severity review will apply only to urgent/emergent inpatient stays of at least one midnight but less than five midnights.
      • Stays of five midnights or greater will not be subject to level of severity review and will be paid at the inpatient DRG (diagnosis related group) rate.
      • For inpatient stays of at least one midnight but less than five midnights that do not meet MCG criteria, providers may request a severity review and engage in a severity discussion with an Aetna medical director.
    • The AHA appreciates Aetna’s decision to delay implementation of its level of severity policy for inpatient hospital admissions from November to January,” the AHA said. “This pause provides additional time for hospitals and health systems to prepare and for continued dialogue on the policy’s impact.” 
  • BioPharma Dive informs us,
    • “Merck & Co. is spending billions of dollars to gain rights to a new kind of preventive flu medicine, hoping that the treatment is poised to become a top seller in the years ahead. 
    • “The pharmaceutical giant on Friday agreed to acquire Cidara Therapeutics, the San Diego-based developer of that medicine, in a deal worth $9.2 billion. Merck is paying $221.50 per share for the company, a 109% premium to its closing price on Thursday. 
    • “News of the pending buyout was first reported by The Financial Times on Thursday.
    • “The deal revolves around a prospect currently known as CD388. It’s an antiviral that combines a small molecule with a protein fragment. Cidara has been evaluating it as a long-acting, preventive therapy for seasonal influenza, one of the world’s most common respiratory infections.”
  • and
    • “Last month, Avadel Pharmaceuticals agreed to sell to fellow Dublin-based drugmaker Alkermes in a deal potentially worth around $2.1 billion. Terms held that Avadel investors would receive $18.50 per share up front, but could eventually take home another $1.50 per share if the company’s main asset — a marketed narcolepsy drug called Lumryz — also gets approved within the next few years to treat a different sleep disorder known as idiopathic hypersomnia. “Wall Street analysts described Lumryz as a “clear” strategic fit for Alkermes, which has been developing its own narcolepsy medicine that’s part of an emerging drug class expected to generate billions of dollars.
    • “But that deal may not materialize, now that another company has submitted a bigger, unsolicited proposal to buy Avadel.
    • “Lundbeck, a Danish drug developer, is offering to pay $21 up front, in cash for each Avadel share, while also providing a “contingent value right” that could be worth as much as $2 per share if certain milestones are met. With that right, half of the value would come from the combined annual net sales of Lumryz and another Avadel asset, valiloxybate, reaching at least $450 million in the U.S. by the end of 2027. The other half would come if annual net sales from those drugs hit $700 million in the U.S. by the end of 2030.”
  • Per Beckers Payer Issues,
    • “As part of the ongoing enterprise-wide recalibration effort to improve financial performance, UnitedHealth Group leadership shared in late October that it would be moving its finance business at Optum under the umbrella of Optum Insight, the company’s data and analytics arm.
    • “We are realigning Optum Financial Services within our Optum Insight Services platform. Many of these actions are underway, and we believe they will improve both our focus and long-term performance,” CEO Stephen Hemsley told investors on the company’s third quarter earnings call.
    • “Optum Financial offers a portfolio of financial products and solutions, including health savings accounts (HSAs), flexible spending accounts (FSAs), payment and claims management services and financial education tools. 
    • “The business unit includes Optum Bank, which serves around five million customers. In 2023, the bank recorded more than $400 million in brokered deposits and almost $600 million in interest income.”
  • Per Fierce Healthcare,
    • “Fabric, a healthcare tech and care enablement company, inked its fifth acquisition in less than three years, acquiring UCM Digital Health.
    • “The deal adds 400 new payer and employer customers and 1 million covered lives across all 50 states. Fabric executives said the acquisition will integrate its AI-enabled virtual care technology and nationwide clinical network with UCM’s deep expertise in serving payers and employers.
    • “For Fabric, it’s about making healthcare more accessible,” said Aniq Rahman, CEO and Founder of Fabric, in a statement. “We’ve already made meaningful progress in the payer and employer markets, and this acquisition allows us to deepen that impact. By bringing more payers and employers onto our platform, we’re creating a connected experience that streamlines workflows, reduces friction and costs, and ultimately drives better outcomes for members and our partners.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • A copy of the new continuing resolution, H.R. 5371, now Pub. L. No. 119-37 is available on Congress.gov.
  • Section 135 of Pub. L. No. 119-37 reads
    • “Sec. 135. Notwithstanding section 101, the matter preceding the first proviso under the heading “Office of Personnel Management—Salaries and Expenses” in title V of division B of Public Law 118-47 shall be applied by substituting “$197,446,000” for “$219,076,000”, and the second proviso under such heading in such title of such division of such Act shall be applied by substituting “$214,605,000” for “$192,975,000”.
  • The referenced section from Pub. L. No. 118-47, the FY 2024 continuing resolution, reads in pertinent part
    • “For necessary expenses to carry out functions of the Office of Personnel Management (OPM) pursuant to Reorganization Plan Numbered 2 of 1978 and the Civil Service Reform Act of 1978, including services as authorized by 5 U.S.C. 3109; medical examinations performed for veterans by private physicians on a fee basis; rental of conference rooms in the District of Columbia and elsewhere; hire of passenger motor vehicles; not to exceed $2,500 for official reception and representation expenses; and payment of per diem and/or subsistence allowances to employees where Voting Rights Act activities require an employee to remain overnight at his or her post of duty, $219,076,000:” * * * and in addition $192,975,000 for administrative expenses, to be transferred from the appropriate trust funds of OPM without regard to other statutes, including direct procurement of printed materials, for the retirement and insurance programs: * * *”
  • So, Congress essentially flipflopped OPM’s appropriation and available trust fund withdrawal for FY 2026. The appropriation was lowered by approximately $22 million, and the trust fund withdrawal was increased by approximately $22 million for FY 2026.
  • Beckers Hospital Review offers five healthcare notes on Pub. L. No. 119-37
  • Fierce Healthcare adds,
    • “Now that the longest government shutdown in U.S. history has come to an end, healthcare organizations are urging lawmakers to act quickly to extend the enhanced Affordable Care Act subsidies.”
  • OPM has released a November 12, 2025, memorandum to Chief Human Capital Officers about “Employee Pay, Leave, Benefits, and Other Human Resources Programs Affected by the Lapse in Appropriations.”
  • Per Govexec,
    • “A senior administration official told Government Executive that federal HR workers are aiming to get the first post-shutdown checks out to employees within the next week. For many agencies, these paychecks will reflect pay furloughed and excepted workers would have earned from Oct. 1 through Nov. 1.
    • “General Services Administration and Office of Personnel Management employees can expect to see a paycheck Saturday, while Energy, Health and Human Services, Veterans Affairs and Defense Department civilian workers will be paid Sunday. On Monday, paychecks are set to go out for workers at the Education, State, Interior and Transportation departments, as well as the Environmental Protection Agency, NASA, National Science Foundation, Nuclear Regulatory Commission and the Social Security Administration.
    • “Another tranche of workers must wait until Wednesday, Nov. 19, to see their backpay, though their checks will also include pay for the Nov. 2-Nov. 15 biweekly pay period, effectively making them whole for time during the shutdown and paying them for their work between Thursday and Saturday of this week: the Agriculture, Commerce, Homeland Security, Housing and Urban Development, Justice, Labor and Treasury departments, and the Small Business Administration.”
  • Tammy Flanagan, writing in Govexec, explains how federal employees over age 65 can navigate FEHB, Medicare and Tricare. (Errata: Yesterday’s FEHBlog included a post about a Govexec article on Medicare Part B late enrollment penalties. Neil Cain, not Tammy Flanagan, wrote that article.)
  • The American Hospital Association News tells us,
    • “Medicaid enrollment decreased 7.6% in fiscal year 2025 and is expected to be mostly flat in FY 2026, according to KFF’s annual Medicaid Budget Survey released today. Meanwhile, total Medicaid spending increased 8.6% in FY 2025 and is projected to grow 7.9% in FY 2026. States cited provider rate increases, greater enrollee health care needs, and growing costs for long-term care, pharmacy benefits and behavioral health services as key drivers of increased costs. Nearly two-thirds of states said they have at least a “50-50” chance of a Medicaid budget shortfall in FY 2026 as they expect tighter fiscal conditions. The report said that states are facing uncertainty in their long-term fiscal outlook due to slowing revenues, rising costs, and changes in economic conditions and federal policy.” 
  • Adam Fein, writing in his Drug Channels blog, informs us,
    • “As I’ve been warning for years, the Inflation Reduction Act of 2022 (IRA) has nearly obliterated the stand-alone Medicare Part D prescription drug plan (PDP) market.
    • “DCI’s exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals:
      • The number of PDPs has plummeted by 55% since the IRA’s passage, to a record low of 360 plans for 2026.
      • Preferred cost-sharing pharmacy networks are disappearing, with their share falling to the lowest level since 2014. That’s a post-IRA net loss of 505 plans with these networks. 
      • Just five companies—Aetna, Health Care Service Corporation, Humana, UnitedHealthcare, Wellcare—will account for 94% of all PDPs in 2026. In recent years, four major plan sponsors—Cigna, Clear Spring Health, Elevance Health, and Mutual of Omaha—have exited the PDP market.
  • STAT News reports,
    • “Vice President JD Vance lauded the Make America Healthy Again movement as an “incredible part” of the Trump administration’s success at a mostly closed-door event at the glitzy Waldorf Astoria on Wednesday.” * * *
    • “The vice president adopted Kennedy’s signature skepticism of traditionally accepted public health interventions. His appearance, attendees said, was interpreted as a clear signal of the importance of the MAHA movement to the future of the Republican coalition — and the importance of the Trump administration to accomplishing MAHA’s goals.
    • “I don’t like taking medications,” Vance said, mentioning an aversion to ibuprofen. 
    • “I don’t like taking anything unless I absolutely have to. And I think that is another MAHA-style attitude. It’s not anti-medication, it’s anti-useless-medication,” he continued.”  

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Kyowa Kirin’s big bet on Kura Oncology has paid off in short order, delivering an FDA approval for a medicine to treat a subset of patients with acute myeloid leukemia.
    • “On Thursday, the FDA signed off on Kura’s menin inhibitor ziftomenib as a new treatment for adults with relapsed or refractory acute myeloid leukemia (AML) who have a susceptible nucleophosmin 1 (NPM1) mutation. To qualify for the treatment, which will be marketed under the brand name Komzifti, patients must not be a good fit for any alternative treatments, the FDA said in a Nov. 13 approval announcement.
    • “While specific treatment options for the roughly one-third of AML patients with NPM1 mutations have historically been limited, Syndax Pharmaceuticals broke new ground in late October when the FDA cleared its drug Revuforj as the first menin inhibitor in the indication. Syndax’s drug was originally approved last November to treat a genetic type of leukemia called lysine methyltransferase 2A (KMT2A).
    • “The two meds, both members of the same class, will now likely compete directly over the indication.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “An influenza strain that emerged over the summer is causing unusually early and severe outbreaks in Canada, the U.K. and Japan, prompting warnings from public health experts about what could be in store for the U.S. as flu season kicks into gear, NBC News reported Nov. 12.
    • “The strain is a version of H3N2, a type of influenza A virus. Influenza A strains are generally known to cause more severe illness, particularly in older adults and young children. Over the summer, it acquired several new mutations, meaning “the virus is quite different to the H3N2 strain included in this year’s vaccine,” Antonia Ho, PhD, an infectious diseases consultant and senior lecturer at the University of Glasgow in Scotland, said in a statement. 
    • “The strain is behind early waves in several countries, experts told NBC. In the U.K., flu cases are already triple what they were around the same time last year and are driving up hospitalizations. Meanwhile, Japan is experiencing an “unprecedented” early flu season, with infections nearly six times what they were at this time last year.” * * *
    • “Vaccine strains are typically selected in February; this year’s shots protect against two types of influenza A and one type of B. Even though the shot is not an exact match for the evolving H3N2 strain, experts say vaccination remains key to reducing the severity of illness and easing strain on hospitals as virus season gathers steam.”
  • Per a November 4, 2025, American Lung Cancer news release,
    • “Today, the American Lung Association released its 2025 “State of Lung Cancer” report, which reveals great strides in efforts to end lung cancer—the leading cause of cancer-related deaths in the U.S. This year, nearly 227,000 people in the U.S. will be diagnosed with lung cancer. The good news is that physicians are detecting lung cancer earlier when it is more likely to be curable, and people are living longer after diagnosis. 
    • “The Lung Association’s eighth annual “State of Lung Cancer” report highlights how the toll of lung cancer varies by state and examines key indicators throughout the U.S., including new cases, survival, early diagnosis, surgical treatment, lack of treatment, screening rates and coverage of comprehensive biomarker testing.” 
  • Fierce Healthcare informs us,
    • “The Leapfrog Group’s latest batch of Hospital Safety Grades is out, and with it a new focus on high performances among system-affiliated hospitals.
    • “The watchdog group’s twice-annual grading, now in its twenty-fifth year, assigned an “A” through “F” letter grade to more than 2,800 acute care hospitals based on patient safety data submitted to the federal government or voluntarily sent to the group through its regular surveys.
    • “The grade includes up to 22 patient safety measures, including a 10-part Medicare composite of reported patient safety and adverse events. Data collected for the grading reached as far back as July 2021 for certain safety measures, including for those collected through Medicare.
    • “This time around, Leapfrog awarded an “A” rating to 899 hospitals (32%), a “B” to 734 (26%), a “C” to 934 (33%), a “D” to 224 (8%) and an “F” to 23 (1%). Compared to the spring’s release, that represents a slight uptick in “C,” “D” and “F” grades.”
  • The Wall Street Journal relates,
    • “Everyone knows walking is good for you, and many of us count our daily steps. But is it better to take a longer walk than a comparable number of steps spread across the day? 
    • “A multinational team of researchers set out to find the answer. Between 2006 and 2010, they recruited adult volunteers from a large-scale health database in Britain, limiting the project to those who averaged less than 8,000 daily steps. It was an older group, ages 40 to 79, with an average of 62, and fairly sedentary, taking a median of 5,165 steps a day. The researchers eliminated those with cancer or cardiovascular disease (CVD). 
    • “The 33,560 who made the final cut wore an accelerometer for about seven days to establish how much they typically walk. Participants were sorted into four categories according to whether they accumulated most of their steps in walks of 5 minutes or less; 5 to 10 minutes; 10 to 15 minutes; or longer than 15 minutes. Scientists tracked them during the 9.5-year study period and published their results in October at annals.org, the website of the Annals of Internal Medicine. 
    • “The main finding: A longer daily walk seems to beat a lot of incidental steps—but there is no need to trek for hours on end. Participants who walked mainly in bouts of at least 15 minutes had an 83% lower risk of dying than those whose walks occurred in bursts of less than 5 minutes. The risk of cardiovascular disease, such as heart attack or stroke, was 68% lower for the longer-session walkers compared with the shortest-burst walkers. 
    • “The study found health benefits even for sedentary people who lengthened their walking sessions but didn’t dramatically increase their steps.”
  • The Washington Post lets us know,
    • Regularly listening to music is linked to a lower risk of developing dementia, according to a new study.
    • In the study, published in October, researchers looked at data spanning a decade and involving more than 10,000 relatively healthy people, aged 70 and older, in Australia. People who listened to music most days slashed their risk of developing dementia by 39 percent compared with those who did not regularly listen to music, the study found.
    • The ASPREE Longitudinal Study of Older Persons followed participants to investigate what factors are associated with the risks of developing various diseases — and how much lifestyle changes could make a difference.
  • Per Fierce Pharma,
    • “Gilead Sciences has developed an industry-leading HIV portfolio in recent years with its megablockbuster daily treatment Biktarvy and its new long-acting pre-exposure prophylaxis (PrEP) medicine Yeztugo. Now, the company is finding success in combining two of the active ingredients in those products.
    • “Gilead’s investigational single-tablet HIV regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) has prevailed in a phase 3 trial, the company announced Thursday.” * * *
    • “People who are on complex regimens for HIV haven’t been able to benefit from single-tablet regimens due to a range of reasons such as resistance to drugs, tolerability and drug-drug interactions, Gilead noted. The promise of the BIC/LEN program is that it could offer a new option for people who remain on complex multi-tablet regimens.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Healthcare cost increases are projected to rise 9.6% in the U.S. in 2026, only a hair less than the 9.7% experienced this year, according to WTW’s 2026 Global Medical Trends report, released Tuesday. However, the increase remains “significantly higher” than the 7.6% seen in 2024. 
    • “Globally, the average cost of health benefits is predicted to rise 10.3%, up from 10% in 2025 and 9.5% in 2024, WTW found. 
    • “Despite variations in healthcare provision in different countries and regions around the world, rising medical costs are a consistent trend for all,” Linda Pham, global health and risk leader for integrated and global solutions for WTW, said in a news release. “One glimmer of hope for employers is that investment in technologies, including AI, is leading to higher costs at the moment but following this phase new technologies hold the promise of reducing healthcare cost trends in the longer term.”
  • Modern Healthcare informs us,
    • “Increased patient volumes and productivity improvements helped drive third-quarter gains for Providence. 
    • “The Renton, Washington-based health system Thursday reported net income of $152 million for the three months ended Sept. 30, compared with net income of $20 million in the same period last year.
    • “Much of the increase came from operations: Providence posted an operating gain of $21 million for the third quarter compared with a $208 million loss in the year-ago period. Operating revenue for the quarter increased 5% to $7.97billion, from $7.58 billion the year before.”
  • and
    • “Labcorp has entered a strategic agreement to acquire select assets of Parkview Health’s outreach laboratory services. 
    • “Financial terms were not disclosed. The deal is expected to close next year, pending closing conditions and regulatory approval, according to a Thursday news release. 
    • “The deal only includes non-emergency outreach laboratory services, the release said. Labs within Parkview’s 15 hospitals would keep providing services to emergency and acute-care patients.”
  • Per Fierce BioTech,
    • “Signed, sealed and delivered, Metsera is finally Pfizer’s. Pfizer has completed its acquisition of the obesity biotech, capping a whirlwind two weeks in which rival pharma Novo Nordisk attempted to swoop in and snatch the startup from under Pfizer’s nose.
    • “As previously announced, Pfizer agreed to pay $65.60 per share upfront for Metsera, while also committing to pay up to $20.65 per share via a contingent value right (CVR). 
    • “The CVR is “tied to the achievement of three specified clinical and regulatory milestones,” Pfizer said in a Nov. 13 release, without providing specifics on the exact goals.
    • “The total deal value of around $10 billion represents a significant uptick from the $7.3 billion value of the companies’ original buyout deal, inked in September.”
  • Bloomberg informs us,
    • “Pfizer Inc. is looking to sell its remaining stake in Covid-19 vaccine partner BioNTech SE, a remnant from one of the pandemic’s most lucrative collaborations. 
    • “The US drugmaker is offering about 4.55 million American depositary receipts via an overnight block trade marketed between $108 to $111.70 per share, according to people familiar with the matter. At the high end of the price range, the stake sale would be worth about $508 million for Pfizer.”
  • Per BioPharma Dive,
    • “Day One Biopharmaceuticals is buying struggling cancer drug developer Mersana Therapeutics, offering $129 million up front to gain control of an experimental cancer drug in early-stage testing, the companies said Thursday.
    • “Per deal terms, Mersana stockholders will receive $25 a share, representing an equity value of $129 million and a roughly 180% premium to the company’s closing stock price on Wednesday. But the bulk of the payouts — an additional $30.25 per share — would only materialize if Mersana’s drug hits a variety of future milestones. The deal’s value would reach $285 million if it does.
    • “Mersana, a developer of a type of targeted cancer treatment called an antibody-drug conjugate, has tested and discontinued several experimental prospects because of safety issues or poor efficacy. Earlier this year, it slashed its workforce and trimmed research to fund operations through late 2026.”
  • Per Beckers Hospital Review,
    • “Amazon Pharmacy will partner with Experity, a healthcare technology platform, to enable patients to order prescriptions during their visit and receive same-day delivery in select markets.
    • “The collaboration will allow patients at urgent care centers to access automatic manufacturer discounts and order medications for direct-to-door delivery through Amazon’s platform, according to a Nov. 13 news release. Amazon Prime members will be eligible for free two-day delivery, and nearly half of U.S. customers are expected to have same-day access by the end of 2025.
    • “A Journal of Urgent Care Medicine study cited in the news release found that patients who received prescriptions onsite at the place of healthcare service had a 2% prescription abandonment rate, compared with 23% for prescriptions that were filled at community pharmacies. Pharmacy-related inquiries also account for 15% of urgent care call volume, the release said.”

Midweek update

David Ermer–CDC, Congress, FDA, Federal employment benefits, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The government shutdown is over. Per the Wall Street Journal,
    • “The GOP-led House passed a spending package reopening the government and President Trump signed it into law late Wednesday, drawing to a close a record-long 43-day shutdown driven by Democrats’ demands to extend expiring healthcare subsides.
    • “The House approved the measure 222 to 209, largely along party lines, two days after the bill cleared the Senate.”
  • The Washington Post reports,
    • “Federal paychecks will begin going out Saturday, a senior administration official said, speaking on the condition of anonymity to discuss personnel matters.
    • “The deal will fund the government through Jan. 30, pass three appropriations bills, reverse more than 4,000 federal layoffs the Trump administration attempted to implement earlier in the shutdown and prevent future layoffs through the end of January. It will appropriate funding for the Supplemental Nutrition Assistance Program, also known as SNAP or food stamps, through September 2026.”
  • The Wall Street Journal discusses the secret meeting that led to this outcome.
    • “A group of centrist Democrats and an independent senator initiated talks with Senate Republicans to end the government shutdown, negotiating without Senate Minority Leader Chuck Schumer.
    • “The negotiations led to an agreement to reopen the government, but it divided Democrats as it didn’t guarantee the extension of expiring Obamacare health-insurance subsidies.
    • “Eight Democrats ultimately supported the deal, providing the critical votes needed to advance the measure to reopen the government with a 60-40 vote.”
  • Beckers Health IT tells us,
    • “Sen. Bill Cassidy, R-La., is pushing to tighten protections for health information gathered by wearable devices and mobile health apps, citing growing privacy concerns as the technology becomes more common, Politico reported Nov. 11.”
  • Per a Senate news release,
    • “On Wednesday, November 19, [at 10 am ET] the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on the U.S. Organ Procurement and Transplantation Network (OPTN) and improving access to lifesaving organs.” * * *
    • “Click here to watch live.”
  • Per the Federal Register, the CDC’s Advisory Committee on Immunization Practices will meet on December 4 and 5, 2025.
    • “The agenda will include discussions on vaccine safety, the childhood and adolescent immunization schedule, and hepatitis B vaccines. The agenda will include updates on ACIP workgroups. Recommendation votes may be scheduled for hepatitis B vaccines. Vaccines for Children (VFC) votes may be scheduled for hepatitis B vaccines. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda, visit https://www.cdc.gov/acip/index.html.” * * *
    • “The docket will be opened to receive written comments November 13 – 24, 2025. Written comments must be received no later than November 24, 2025.”
  • Neil Cain, writing in Govexec, discusses the Medicare Part B late enrollment penalty for folks enrolled in the FEHB program.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration is unveiling a new blueprint for the regulation of bespoke drug therapies, announcing on Wednesday a way for these treatments to quickly get to market if they meet certain standards.
    • “Called the “plausible mechanism” pathway, the new framework is designed to help accelerate treatments for serious conditions that are so rare they may only affect individuals or handfuls of people and can’t feasibly be tested in randomized clinical trials. It was announced through an article authored by FDA Commissioner Martin Makary and top deputy Vinay Prasad and published Wednesday in the New England Journal of Medicine.
    • “Critics may contend that there is no need for an alternative pathway and that existing FDA operations are able to address bespoke, transformative therapies,” they wrote. “Unfortunately, the FDA has heard from patients, parents, researchers, clinicians, and developers that current regulations are onerous and unnecessarily demanding, provide unclear patient protection, and stifle innovation. We share this view.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP relates,
    • “Arizona and Utah reported an increase in measles case counts today, as did South Carolina, according to state dashboards. 
    • “The outbreak that straddles the Utah-Arizona border has now grown to 182 cases, and is the second largest measles outbreak this year following the West Texas outbreak, which sickened at least 762 people, with three deaths.” * * *
    • “The Upstate outbreak in South Carolina also grew, with eight more cases reported by the South Carolina Department of Public Health today. The state total is now 46.
    • “Six of the eight new patients are household members of previously identified patients. All new patients are in quarantine. 
    • “Two cases, however, occurred within the same household, but the source of infection is unknown.”
  • and
    • “A test-negative, case-control study across 14 hospitals in England finds that the respiratory syncytial virus (RSV) pre-F (Abrysvo) vaccine helps protect against related hospital admissions in older adults. 
    • “For the study, published in The Lancet Infectious Diseases, UK researchers identified 1,006 adults aged 75 to 79 hospitalized with acute respiratory illness (ARI) from October 2024 to March 2025. The participants were predominantly White, with a mean age of 80 years and had a high rate of chronic conditions such as heart and respiratory disease and immunosuppression. 
    • “The researchers noted that while the RSV vaccine has been shown to protect against all-cause RSV-associated hospital admissions, there’s limited data on the vaccine’s effectiveness against different RSV-associated illnesses and complications such as exacerbation of chronic illness.”
  • Per a November 11, 2025, City of Philadelphia news release,
    • “The Philadelphia Department of Public Health is notifying travelers and others who were at the Philadelphia International Airport Terminals A and B on Sunday, November 9, 2025, between 8:50 am and 4:00 pm of a possible measles exposure. The individual with measles was traveling through the airport. The Health Department is encouraging people who were exposed to check their vaccination status and watch for symptoms.”
  • Biopharma Dive reports,
    • “An antimalarial drug developed by Novartis could become the first novel treatment for the parasitic infection in more than two decades, following study results that showed it helped cure most people treated with it in a Phase 3 trial.  
    • “According to Novartis, the therapy, known in short as GanLum, was “non-inferior” to standard treatment in a trial evaluating it in 1,688 adults and children. By one analysis, the drug helped clear symptoms and signs of initial infection in 97% of recipients after 28 days, versus 94% among those receiving standard drugs. By another, that cure rate was as high as 99%. Novartis added that treatment appeared effective against drug-resistant parasites and was able to block disease transmission.
    • “The results cleared the World Health Organization’s 95% target and positions Novartis to seek approvals of GanLum “as soon as possible,” the company said in a statement Wednesday. If so, it would help combat growing resistance to a class of medicines, called “artemisinins,” that have been the gold standard for treating malaria since 1999.” 
  • The New York Times informs us,
    • “In a modern glass complex in Geneva last month, hundreds of scientists from around the world gathered to share data, review cases — and revel in some astonishing progress.
    • “Their work was once considered the stuff of science fiction: so-called xenotransplantation, the use of animal organs to replace failing kidneys, hearts and livers in humans.
    • “But as the scientists traded notes, it became ever more clear that it wasn’t fiction anymore. They were nearing breakthroughs that might help alleviate the shortage of donor organs plaguing every nation.
    • “Transplants with organs from genetically modified pigs, designed not to trigger rejection by the human body, have begun to show great promise. “The future is here,” said Dr. Muhammad M. Mohiuddin, the outgoing president of the International Xenotransplantation Association, which hosted the conference.”
  • Per Beckers Oncology,
    • “GLP-1 medication use was associated with lower mortality among colon cancer patients, according to a study published Nov. 11 in Cancer Investigation. 
    • “Researchers from the University of California San Diego used real-world clinical data from the University of California Health Data Warehouse to assess any association between GLP-1s and five-year mortality in 6,871 colon cancer patients.”
  • Per a JAMA Cardiology report,
    • “In this cross-sectional study among a nationally representative sample, chronic kidney disease (CKD) affected 1 in 7 US adults, yet fewer than 15% of adults with CKD were aware of their diagnosis. Although overall awareness increased modestly from 2011 to 2020, younger adults, women, and Hispanic adults experienced lowest awareness rates without improvement. These findings highlight a significant gap in CKD recognition and underscore the need for targeted strategies to improve awareness in the population.”
  • The Los Angeles Times reports,
    • “Food always powered Anahi Araiza through study sessions and cultural gatherings. But after putting on some weight in her college years, she decided to get serious about weight loss, often restricting her food consumption overall — and that’s when everything shifted.
    • “One day, I overate whatever calories or macros I established for myself,” says Araiza in a phone call. “Then it turned into a spiral where every single day I was unable to do anything but think about food.”
    • “After a while, she developed binge eating disorder (BED), which is defined as repeated episodes of binge eating, or eating large amounts of food quickly.””
    • “BED is the most common eating disorder in the United States, yet it is chronically underdiagnosed among Latino communities.”
  • Neurology Advisor lets us know that “Early Administration of Remote Electrical Neuromodulation Enhances Migraine Relief.”
  • Per Radiology Business,
    • “New research is raising questions pertaining to the effectiveness of a newer Alzheimer’s treatment that has been proven to reduce cognitive symptoms related to the disease. 
    • “Lecanemab, sold under the brand name Leqembi, was approved by the U.S. Food and Drug Administration in January 2023. The monoclonal antibody treatment treats early Alzheimer’s disease (AD) by essentially scrubbing the brain of amyloid-β (Aβ) plaques.   
    • “The drug’s approval was roundly celebrated at the time, as clinical trials suggested it could reduce Alzheimer’s-related cognitive decline by up to 27%. Post-approval data has been positive as well, but new research out of Osaka Metropolitan University in Japan is prompting new questions on the mechanisms that underlie the drug’s therapeutic effects. 
    • “Published in the Journal of Magnetic Resonance Imaging, the findings suggest lecanemab does not change the waste clearance function in the brains of AD patients in the short term. This could indicate that the medication does little to treat the nerve damage AD has inflicted on the glymphatic system, which clears waste from the brain, prior to starting the treatment.” “
  • Per Medscape,
    • “Statin therapy remains a cornerstone for primary and secondary prevention of major adverse cardiac events (MACEs) but prescribing based on patient phenotype identified through imaging may boost its effectiveness, according to a new study.
    • “While population-level primary-prevention trials have established the efficacy of statins, it remains unclear whether their benefit depends on the extent of underlying atherosclerotic disease. Our work addresses this evidence gap by assessing whether the treatment effect varies with disease characteristics,” lead investigator Bálint Szilveszter, MD, PhD, a researcher at the Semmelweis University Heart and Vascular Centre in Budapest, Hungary, wrote in an email to Medscape Medical News.
    • “Clarifying this relationship could enable more personalized and also intensified therapy,” Szilveszter added.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Key provider performance metrics appear steady in aggregate but are showing stark differences between hospitals and practices at the top and bottom of their class, according to a pair of new reports from Kaufman Hall.
    • “For hospitals, the firm’s operating margin index was 2.9% across nine months of 2025 (including health system allocations for the cost of shared services), a slight uptick from the 2.5% reflected through eight months. Splitting the report’s 1,300 nationwide hospitals into quartiles, however, showed a 14.7% year-to-date operating margin index among the top 25% of hospitals and a -1.8% year-to-date operating margin for the bottom quartile of hospitals.
    • “The gap between strong performers versus struggling hospitals continues to widen,” said Erik Swanson, managing director and data and analytics group leader with Kaufman Hall, said of the trend in a release.
    • “Broadly speaking, the overall margin improvement from August to September stemmed from greater volumes and per-adjusted-admission revenue gains and was partially mitigated by higher supply and drug costs, according to the firm’s monthly report. On a month-over-month basis, daily net operating revenue rose 4%, daily total expense rose 3% and daily adjusted discharges increased 2%.”
    • “As for practices, Kaufman Hall’s quarterly check-in highlighted, for the first time since the COVID-19 pandemic, a sequential decline in the median investment/subsidy per provider in medical groups. That metric—net patient service revenue minus total expense, then divided by provider full-time equivalents—was $237,911 in Q3, a 1% year-over-year increase but a minor dip from Q2’s $239,338.
    • “Similar to hospitals, however, Kaufman Hall found a disparity within the report’s sample of 200,000 providers. The investment/subsidy per provider at the 25th percentile was $141,371, but $325,634 at the 75th percentile.”
  • and
    • “The country’s largest for-profit hospital chain isn’t sitting on its hands when it comes to artificial intelligence.
    • “Speaking Wednesday morning at the 2025 UBS Global Healthcare Conference, HCA Healthcare Executive Vice President and Chief Financial Officer Michael Marks offered an update on key clinical, operational and administrative deployments of AI tools across the 191-hospital system.
    • “Broadly, I’m pleased with where we are,” Marks said. “We’re in early innings with this effort. We’re trying to be judicious in our allocation of resources and making sure that we’re getting either a clinical or a financial return on these investments as we scale them.”
    • “Clinical use cases are the steepest hill for AI due to the “inherent risks” around patient safety, the executive said, and as such are taking longer to roll out. Still, HCA has multiple projects aimed at improving patient safety and quality outcomes, among which is a partnership with Google to tighten the roughly 400,000 weekly shift handoffs between the system’s nurses.”
  • MedCity News considers “What Are the Biggest Mistakes Employers Make When Introducing Digital Mental Health Solutions? At the Behavioral Health Tech conference, panelists said employers often rush to adopt digital mental health tools without tailoring them to employee needs or effectively promoting their use.”
  • HR Dive informs us,
    • “Employers significantly misjudge how well their benefit offerings are meeting employee demands: While 75% believe their workforce is satisfied with what they offer, only 65% of employees agree, according to Aflac’s 2025-2026 benefits trend report.
    • “One noticeable misunderstanding involves communication, spring surveys of 1,002 employers and 2,000 employees across the U.S. found. Nearly 2 in 5 (37%) of employees said they want to talk to a real person to help with benefits enrollment, but only 28% of employers offer this option. Similarly, 32% of employees said they want one-on-one access to a benefit consultant, but only 28% of employers provide it.
    • “Employers are also out-of-touch with employee concerns about medical bills: 78% believe employees can handle this financial burden, but 44% of workers say they couldn’t cover $1,000 in unexpected health expenses. Almost 1 in 5 (19%) said they wouldn’t be able to afford $500 in healthcare costs.”

Tuesday report

David Ermer–ACA, Congress, FDA, Medical / Rx research, U.S. Healthcare–

Happy Veteran’s Day

From Washington, DC,

  • Per the Senate press gallery, as of 9:49 pm last night,
    • “The Senate stands adjourned and will meet for pro forma sessions only on the following dates: 
      • “Thursday November 13th, 2025, at 6:30 p.m.
      • “Monday November 17th at 3:00 p.m. 
    • “The Senate will next convene on Tuesday November 18th, 2025, at 3:00 p.m. Following Leader Remarks, the Senate will be in a period of morning business.”
  • The Hill reports,
    • “Speaker Mike Johnson (R-La.) will swear in Rep.-elect Adelita Grijalva (D-Ariz.) on the House floor Wednesday at around 4 p.m., his office said in a media advisory, ahead of a House vote to reopen the government. 
    • “He had declined to swear in Grijalva, who was elected in September, during the shutdown as he kept the House out of session in a bid to pressure Senate Democrats to vote to reopen the government.”
  • and
    • “Top Trump administration officials including Vice President JD Vance and Health Secretary Robert F. Kennedy Jr. are slated to speak alongside biotech executives and influencers at an all-day “Make America Healthy Again” summit on Wednesday that has not been publicly disclosed. 
    • “According to an agenda seen by The Hill, the event will feature many of the country’s leading health officials, including: Centers for Medicare and Medicaid Services Administrator Mehmet Oz, Food and Drug Administration Commissioner Marty Makary, National Institutes of Health Director Jay Bhattacharya, acting Centers for Disease Control and Prevention Director and HHS Deputy Secretary Jim O’Neill, Medicare Director Chris Klomp, and White House AI czar David Sacks.” 
  • Accord points out that this will be the 11th year of ACA reporting and five items are worth exploring before filing the 2025 forms.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Infant-formula maker ByHeart has recalled all of its products in the U.S. after the Food and Drug Administration opened an investigation into a multistate botulism outbreak.
    • “A total of 15 infants with suspected or confirmed cases of botulism have been reported in a dozen states, the FDA said Tuesday. Each child consumed ByHeart Whole Nutrition Infant Formula products, and all were hospitalized, the agency said. No deaths have been reported. 
    • ‘ByHeart hasn’t found any spores that produce botulism in any unopened can of its formula, the company said. The company recalled all of its products under an abundance of caution, it said.
    • “Epidemiologic and laboratory data show that ByHeart’s infant formula might be contaminated with spores that cause botulism, the FDA said. 
    • “The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions,” said Mia Funt and Ron Belldegrun, co-founders of ByHeart. “Your baby’s safety is, and always will be, our biggest priority.”
  • Per an FDA news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA and the founding director of its Oncology Center of Excellence.
    • “A renowned regulatory innovator, Dr. Pazdur developed an integrated approach for cross-center coordination of oncology product review to expedite the development of novel cancer therapies. He also led the agency’s launch of a series of initiatives that streamlined oncology drug approvals, access, and labeling: Project Orbis to provide a framework for concurrent submission and review of oncology products among international partners, Project Facilitate to support oncology professionals in completing expanded access requests for cancer patients, and Project Renewal to update the prescribing information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
    • “Dr. Pazdur is a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process,” said FDA Commissioner Marty Makary, M.D., M.P.H. “He has a track record of success and is an impressive forward-thinking scientist.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “A program in which Dietary Approaches to Stop Hypertension (DASH)-style groceries were delivered to residents of “food deserts” reduced blood pressure, but this effect did not continue after the program ended, the randomized GoFresh trial showed.
    • “Among Black adults living in urban communities with a low number of grocery stores at 3 months, mean systolic blood pressure decreased by 5.7 mm Hg (95% CI -7.4 to -3.9) in those who received weekly low-sodium DASH-patterned groceries with dietitian counseling versus a decrease of 2.3 mm Hg (95% CI -4.1 to -0.4) in the group who received three $500 stipends every 4 weeks intended for self-directed grocery shopping (P=0.009), reported Stephen Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, at the American Heart Association annual meeting.
    • “The DASH group also had reductions in mean diastolic blood pressure (-2.4 mm Hg, 95% CI -4.2 to -0.5), urine sodium level (-545 mg/24 h, 95% CI -1,041 to -50), and low-density lipoprotein (LDL) cholesterol (-8.0 mg/dL, 95% CI -13.7 to -2.3). There were no effects observed for body mass index or HbA1c level.
    • “The findings were also published in JAMA.
    • “Interestingly, after the grocery delivery was ended, participants’ blood pressure went back up, suggesting that the provision of groceries to the families in these regions was needed to maintain the blood pressure,” Juraschek said during his presentation.
    • “Longer-term maintenance of these benefits will likely require sustained access to healthy groceries and nutrition counseling,” the researchers concluded.”
  • and
    • “With new guidelines for the treatment of moderate to severe asthma, experts noted a shift toward increasing caution in corticosteroid use.
    • “I think the shift from the guidelines and from all the data that we’re accumulating over time is that minimizing oral corticosteroids or systemic corticosteroids is going to be a focus,” said Jay Lieberman, MD, of the University of Tennessee Health Science Center in Memphis, who spoke as part of a panel discussing the upcoming guideline update at the American College of Allergy, Asthma & Immunology (ACAAI) meeting.”
  • and
    •  “A conservative dialysis strategy improved rates of kidney function compared to conventional thrice-weekly dialysis in patients with acute kidney injury (AKI) undergoing kidney replacement therapy (KRT), a new clinical trial found.
    • “In patients who received dialysis only when specific conditions were met, 64% achieved kidney function recovery at hospital discharge versus 50% of the those assigned to receive dialysis three times per week (unadjusted odds ratio 1.76, 95% CI 1.02-3.03, P=0.04), reported Chi-yuan Hsu, MD, of the University of California San Francisco, at the American Society of Nephrology Kidney Week meeting.
    • “The study, which was simultaneously published in JAMA, also found that participants in the conservative dialysis group received fewer sessions per week (median 1.8 vs 3.1, P<0.001) and recovered earlier, with more consecutive dialysis-free days by day 28 (21 vs 5, P<0.001).
    • “We think this is important, because coming off dialysis is a major, major patient-oriented outcome, and that’s been neglected, I think, in nephrology,” Hsu said in a presentation at the meeting. “We’ve done several studies showing that once you leave the hospital and you go to the outpatient setting, the dialysis unit is geared towards chronic dialysis patients, and there’s not a lot of effort made to get people off dialysis.”
  • Per Healio,
    • “A study of more than 13,000 people with cancer yielded further evidence that quitting smoking soon after diagnosis can considerably prolong survival.
    • “Individuals who quit smoking within 6 months of a cancer care appointment exhibited half the risk for all-cause mortality as those who continued to smoke, results published in JNCCN — Journal of the National Comprehensive Cancer Network showed.
    • “The survival benefit of quitting appeared even stronger among people with advanced cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “UnitedHealth Group Chief Financial Officer Wayne DeVeydt offered additional color on the company’s turnaround efforts at an investor conference Tuesday.
    • “DeVeydt spoke at the UBS Global Healthcare Conference, where he reaffirmed the company’s broader expectations that its performance will improve in 2026 before its new strategic approach really pays off in 2027, particularly changes at Optum Health and Optum Insight. 
    • “DeVeydt took the CFO chair early September, succeeding John Rex. He said part of what lured him to take the role was CEO Stephen Hemsley’s confidence that the company can make real progress in short order. He said the team is still early in the journey to recapture “the swagger the company once had.”
    • “Having competed against this organization for years both as the CFO of Elevance and then on the board of Centene, the one thing that’s very clear to me is the assets are as good as I thought they were,” DeVeydt said. “The management team actually is quite deep, albeit we’ve made a number of changes along the way.”
  • Beckers Hospital Review tells us,
    • “After achieving a $2.6 billion financial turnaround in two years and restructuring its hospital portfolio, St. Louis-based Ascension is pushing even further, lining up a bold bet on ambulatory surgery centers and making outpatient and value-based care central to its future strategy.
    • “The faith-based system is expected to finalize its acquisition of AmSurg — an ASC operator with more than 250 facilities across 34 states — by the end of 2025 or early 2026. The proposed deal is reportedly valued at about $3.9 billion.
    • “We truly think this AmSurg partnership will be transformational for our organization,” Amber Sims, executive vice president, chief strategy and growth officer at Ascension, said during a Nov. 3 panel at Becker’s CEO and CFO Roundtable in Chicago. “We really tightened our portfolio and recognized that we have to get ahead in the ambulatory business, because that’s where care is going. It’s where patients want to receive care, where payers want to seek care, and where providers want to provide care.”
  • Healthcare Dive informs us,
    • “Indiana’s health department has approved Union Hospital’s acquisition of Terre Haute Regional Hospital, despite opposition to the deal from antitrust regulators in both the Biden and Trump administrations.
    • “Gov. Mike Braun announced the green light on Sunday after state regulators approved Union’s application for a Certificate of Public Advantage, clearing the way for the merger to be finalized. It’s the state’s first approval under its law allowing COPAs, which are controversial mechanisms that make it easier for potentially anticompetitive hospital mergers to pass regulatory review.
    • “Braun said the merger, which Union has pursued for years, would lower prices and make healthcare more accessible for Indiana residents. However, the Federal Trade Commission and independent antitrust experts have found that the merger will raise costs, worsen access for patients and lower wage growth for hospital workers.”
  • Per BioPharma Dive,
    • “MeiraGTx has formed another partnership with a large drugmaker, this time striking a deal that hands Eli Lilly rights to an experimental gene therapy for an inherited eye disorder. 
    • “Lilly will pay MeiraGTx $75 million up front for exclusive rights to the therapy, which targets an ultra-rare, blinding condition called Leber congenital amaurosis-4. MeiraGTx could receive another $400 million as well as royalties if the treatment, AAV-AIPL4, hits certain research and commercialization targets.
    • “The deal also grants Lilly access to MeiraGTx’s gene therapy tools and certain rights to its “riboswitch” gene-regulating technology, all of which will be used to develop treatments for eye conditions. 
    • “The partnership “provides the opportunity for these innovative technologies to be used much more broadly than we have the capacity to do alone, and in that way, reaching more patients and transforming more lives,” Alexandria Forbes, MeiraGTX’s CEO, wrote in an email to BioPharma Dive.”

Monday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Hill reports,
    • “The Senate on Monday is holding a series of votes to possibly pass the proposal that could reopen the federal government. 
    • “Monday’s series, which will include up to eight votes, kicked off shortly before 6 p.m. and will conclude with a vote on final passage.
      • FEHBlog note — The Senate did pass a Sen. Susan Collins substitute to the HR 5371 which will go back to the House for a vote perhaps as early as Wednesday. Here is a link to a later Monday Hill report.
    • “Speaking at the White House earlier Monday, President Trump indicated he would back the Senate deal. The bill will still need to pass the House if the Senate votes to advance it.”
  • Federal News Network adds,
    • “The Senate’s initial agreement toward ending the longest-ever government shutdown includes provisions that would secure back pay for all federal employees, as well as reverse the Trump administration’s recent reductions in force.” * * *
    • “The Senate’s legislation over the weekend would also compel agencies to reverse all reduction-in-force actions that have taken place since the shutdown began. About 4,200 federal employees across government received RIF notices in mid-October, following guidance from the White House that encouraged agencies to move forward with layoffs in the event of a funding lapse.
    • “Most, but not all, of those RIF actions are currently on hold due to a preliminary injunction granted by a district court judge last month. Federal unions are suing the Trump administration over the layoffs, alleging that they violate the Administrative Procedure Act.”
    • “The Senate’s tentative agreement would also temporarily bar the Trump administration from conducting further RIFs until late January.”
  • Healthcare Dive tells us,
    • “House Democrats introduced a bill on Friday to repeal a CMS innovation center payment model that will add artificial intelligence-backed prior authorization for some services in Medicare. 
    • “The Wasteful and Inappropriate Service Reduction, or WISeR, model will implement prior authorization in six states starting in January. The CMS last week announced health technology companies that will administer the model.
    • “The six Democrat representatives behind the legislation say WISeR will add red tape and limit access to care for Medicare seniors. “It is not an exaggeration to say that the requirement of prior authorization for traditional Medicare services will kill seniors,” said Rep. Mark Pocan, D-Wis. “Not only that, but the use of AI in determining whether or not treatment is necessary is extremely reckless.”
  • Govexec informs us,
    • “The federal government’s backlog of pending retirement claims hit the highest level since the COVID-19 pandemic last month, as tens of thousands of federal workers who accepted the Trump administration’s so-called deferred resignation program.
    • “While January and February are traditionally the busiest months for processing federal employees’ retirement applications, the deferred resignation program, stemming from Elon Musk’s controversial “fork in the road” email, created a new logjam last month, as most who agreed to leave federal service through the initiative did were paid through Sept. 30. A second tranche is expected next January, as some DRP participants were allowed to remain on paid leave through the end of the calendar year in order to reach retirement eligibility.”
    • “All told, OPM received 20,344 new retirement claims in October. The agency processed 8,751 applications during the same time period—an increase over September’s 7,902 despite the ongoing government shutdown—causing the agency’s backlog to balloon to 34,587 pending claims.”
  • Kevin Moss, writing in Govexec, offers advice on how to assess choices created by the Federal Benefits Open Season, which began today.
    • “From rising premiums to fewer plan choices, this guide walks you through reviewing benefits, checking provider networks and using tax-advantaged accounts to keep your healthcare costs in check next year.”
  • OPM Associate Director for Healthcare and Insurance Shane Stevens also gives Open Season advice on You Tube.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration said manufacturers should remove black box warnings on hormone-replacement therapy drugs, citing clinical trials showing no association with increased breast cancer risk.
    • “The black box warnings may have kept many women away from what life-changing treatment could be, the head of the FDA said Monday in an opinion piece published in The Wall Street Journal.”
  • MedTech Dive lets us know,
    • “MMI said the Food and Drug Administration approved an investigational device exemption to study a microsurgical intervention for Alzheimer’s disease using the company’s Symani robotic platform.
    • “The REMIND study will evaluate the safety and feasibility of the procedure to improve drainage of neurotoxins, such as amyloid beta and phosphorylated tau, from the brain in patients with mild to moderate Alzheimer’s disease and obstruction in the deep cervical lymph nodes of the neck.
    • “The study’s primary endpoint is device-related serious adverse events through 30 days after the procedure. Additional endpoints include biomarker and imaging changes, and cognitive assessments through six months.”

From the public health and medical / Rx research front,

  • PlanSponsor reports,
    • Four industry experts attending the Milken Institute’s Future of Health Summit 2025 noted that as Americans live longer, the challenge is not just adding years to their lives, but making sure that time includes quality, health and financial security.
    • During the panel, “The Longevity Equation: Integrating Healthspan and Wealthspan,” the speakers explored innovative strategies and systems intended to help close the gap between what people need and what the current system delivers, given today’s demographic realities.
    • “It’s great that people are living longer, but it’s important to acknowledge the disparities between their wealth span, lifespan and health span,” said Alberto Casellas, the executive president and CEO of health and wellness at Synchrony Financial. “We haven’t spoken enough about saving for [their] health.”
  • The American Medical Association lets us know what doctors wish their patients knew about sleep apnea.
  • Per Health Day,
    • “Women diagnosed with advanced breast cancer can now expect to live an extra six or seven months compared to about a decade ago, researchers report.
    • “This increase in survival time coincides with the development of more effective treatments for advanced breast cancer, as well as wider improvements in diagnosis and quality of care, researchers said.
    • “In particular, women with breast cancers driven by known biological factors have seen a dramatic improvement in their outlook, thanks to better targeted therapies.
    • “Survival time for patients with advanced breast cancer, where the cancer has spread to other parts of the body, is much lower compared to early breast cancer,” senior researcher Dr. Fatima Cardoso said in a news release. She’s president of the Advanced Breast Cancer Global Alliance in Lisbon.
    • “The major treatments for this stage of breast cancer are systemic therapies, like hormone therapy, chemotherapy and targeted therapy, that aim to kill cancer cells wherever they are growing in the body,” Cardoso said. “In the last 15 years, we have seen a number of new systemic therapies developed and become available to some patients.”
  • Biopharma Dive relates,
    • “An experimental and closely watched drug for multiple sclerosis has delivered positive results in two late-stage clinical trials, giving its developer confidence it could change how the disease is treated.
    • “Roche said Monday that the drug, called fenebrutinib, hit the main goal of a trial focused on the most common, “relapsing” form of MS. According to Roche, participants taking fenebrutinib as opposed to Sanofi’s Aubagio showed a significant decrease in the average number of relapses — periods where neurological symptoms flare up or worsen — experienced in a year. A second, similarly designed experiment should produce results in the first half of 2026.
    • “Additionally, fenebrutinib succeeded in a separate study that enrolled nearly 1,000 people with “primary progressive” MS. The drug was “non-inferior” at slowing the disease compared to Roche’s Ocrevus, a blockbuster product and the only approved therapy for this more severe kind of MS.”
  • Per MedPage Today,
    • “In a phase I trial, an intranasal adjuvanted recombinant influenza vaccine appeared to result in response to a range of H5N1 clades.
    • “The adjuvanted vaccine elicited seroconversion against clade 2 subclades, including the avian influenza H5N1 clade.
    • “Post-dose reactogenicity symptoms to the adjuvanted vaccine were common and mostly mild.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente and its subsidiaries posted a $218 million operating income, or a 0.7% operating margin, for the third quarter of 2025, the country’s largest nonprofit health system shared Friday in a release.
    • “The integrated care organization painted its operating performance as below average for nonprofit healthcare entities. Still, the tally is still well ahead of its $608 million operating loss (-2.1% operating margin) from the third quarter of 2024, when higher-than-expected utilization, pharmacy costs and other factors triggered a push to reduce spending.
    • “Kaiser also benefited from a strong financial market conditions that fueled a $2.4 billion nonoperating income for the quarter. This gave the organization a bottom-line net income of $2.6 billion, again much stronger than the prior year’s $845 million.
    • “Consolidated operating revenues for the quarter hit $31.8 billion, up about 99.7% year over year, while operating expenses hit $31.6 billion, a roughly 6.8% increase. Membership across Kaiser and its Risant Health affiliates was more than 13.1 million as of Sept. 30, roughly the same as when it closed its second quarter June 30.”
  • Beckers Payer Issues recounts that “health insurers spent the third quarter resetting pricing models and narrowing their product portfolios as medical cost trends remained elevated and Medicare Advantage headwinds intensified heading into 2026.”
  • Beckers Hospital Review points out,
    • “Twenty-seven labor and delivery units at rural hospitals have shuttered in 2025, up from 21 in 2024, according to a new report from the Center for Healthcare Quality and Payment Reform.
    • “The report found that since year-end 2020, 116 rural hospitals have ended deliveries or planned to do so by year-end 2025. Rural L&D units have closed in most states over the last five years, and in three states, at least one-quarter of rural hospitals with maternity services have ended deliveries. Only 41% of U.S. rural hospitals provide L&D services, with less than one-third offering them in 12 states. 
    • “The findings highlight a concerning trend, driven by limited alternative revenue streams or inadequate reimbursement, which suggests that more rural communities could be at risk of losing maternity care due to the financial uncertainties of offering the services.”
  • and
    • “Since June, Jacksonville, Fla.-based Nemours Children’s Health has cared for more than 120 children with complex medical conditions at home through a first-of-a-kind program.
    • “The Advanced Care at Home program is designed for children who are medically stable but require ongoing advanced care. It is the nation’s first at-home care model operated by a freestanding children’s hospital, according to a Nov. 10 news release from Nemours.
    • “Since its launch, the program has helped avoid 177 inpatient days, 27 hospital readmissions and 91 emergency department visits, Nemours said.” 
  • MedTech Dive notes,
    • “Laborie Medical Technologies has struck a deal to buy a post-childbirth medical device from Organon for $440 million upfront, the companies said Friday.
    • “The acquisition covers the Jada system, a treatment for abnormal postpartum uterine bleeding or hemorrhage, and around 100 employees who will transfer to Laborie as part of the deal.
    • “Organon acquired the system in 2021 for an initial $219 million. The women’s health specialist grew sales from $20 million in 2022 to $61 million in 2024 as more hospitals stocked the system.”

Weekend update

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From the Washington, DC,

  • The Wall Street Journal reports,
    • “The Senate was driving toward a deal to end the record government shutdown, with the top Senate Republican saying to expect a vote as soon as Sunday but also warning that an unpredictable negotiation could still hit some snags.” * * *
    • “We’re close to the finish line,” said Sen. Catherine Cortez Masto (D., Nev.), a centrist who is one of three Democrats who have repeatedly voted to fund the government.
    • “The Senate Appropriations Committee released three full-year funding bills, covering veterans’ programs and the construction of military housing as well as the Agriculture Department and the legislative branch. An interim measure expected to temporarily fund the rest of the government still hadn’t been released, and Republicans didn’t specify how the main Democratic demand to extend expiring healthcare subsidies would be handled.
    • “Any deal would still need approval in the House of Representatives, which has been out of session since Sept. 19. House Speaker Mike Johnson (R., La.) has put members on notice that he would give them 48 hours to return in the event the Senate passed a spending bill.
    • “A key development that appeared to break the logjam in the negotiations was that Senate Republicans proposed that some healthcare funding be provided directly to households rather than be used to pay for a one-year extension of enhanced ACA subsidies.
    • “That GOP proposal involves sending federal money into flexible-spending accounts instead of to insurance companies that use the money to offset the cost of premiums, so consumers pay a smaller monthly bill. The money could be used to cover deductibles and other out-of-pocket costs, which Republicans see as a way to give consumers more choice and control healthcare inflation.”
  • The cloture resolution to the continuing resolution to end the shutdown passed by the minimum 60-40 vote last night. Roll Call explains,
    • “The vote had been held open for over two hours allow for Sen. John Cornyn, R-Texas, the 60th vote, to return to the Capitol. He’d been back home over the weekend officially filing as a candidate for re-election next year in his state’s Republican primary.”
    • Eight Democratic senators voted aye per the Wall Street Journal.
  • Roll Call adds,
    • “The new continuing resolution would extend current funding levels through Jan. 30, along with three full-year appropriations bills covering the Departments of Agriculture and Veterans Affairs as well as legislative operations. It also carries a host of “extender” provisions for authorizing committees that haven’t completed work on other bills, mostly through January, though there is a one-year farm bill extension.” * * *
    • “Senate Majority Leader John Thune, R-S.D., said the arrangement includes a commitment to vote on a Democratic-drafted extension of expanded health insurance subsidies by mid-December, ahead of their Dec. 31 expiration.
    • “Another key provision for Democrats who’d been on the fence would reverse mass layoffs announced by the Trump administration since the shutdown began Oct. 1, at least while the government remains open.”
  • The Senate needs to enact the continuing resolution which requires a majority vote and then the continuing resolution heads over to the House of Representatives again for a majority vote. The President must sign the continuing resolution to enact it. Because Tuesday is a federal holiday, the shutdown will continue into later this week.
  • There are no Congressional committee meetings scheduled for this week.
  • The Federal Benefits Open Season begins tomorrow. OPM notes
    • “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 8, 2025, for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) and Postal Service Health Benefits Program (PSHB) ends at 11:59 pm, per the location of your electronic enrollment system, on Monday December 8, 2025.”

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “Federal health officials are investigating a multistate outbreak of infant botulism linked to ByHeart baby formula, prompting the company to recall two batches of one of its products.
    • “Thirteen babies in 10 states have been hospitalized as a result of the outbreak, the Food and Drug Administration and Centers for Disease Control and Prevention said. No deaths have been reported.
    • “ByHeart recalled two batches — 206VABP/251261P2 and 206VABP/251131P2, both with a “Use by” date of Dec. 1 — of its Whole Nutrition Infant Formula, the FDA said in a statement Saturday. The code and date can be found on the bottom of the container, the agency said. The company said the recall was voluntary and “out of an abundance of caution.” * * *
    • “The 13 cases linked to ByHeart formula were reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. The ages of the affected children were from around 2 weeks to 5 months old, the CDC said.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Merck, the company that introduced statins to the world nearly 40 years ago, has a new, intensely powerful pill that can slash levels of dangerous LDL cholesterol to levels almost never seen in adults.
    • “The new pill, enlicitide, blocks a liver protein, PCSK9, that slows the body’s ability to clear cholesterol. With most PCSK9 blocked, LDL levels plummet and rates of heart attacks and strokes in high risk patients fall by up to 20 percent in just the first year.
    • “At least six million adults in the United States are eligible for drugs that block PCSK 9.
    • “Merck’s head of research said the goal is to make the pill affordable. It would be an alternative to expensive biweekly or monthly injections of monoclonal antibodies that do the same thing. But only around one percent of eligible patients take the injections, which include Praluent by Regeneron and Sanofi, and Repatha by Amgen. Many patients don’t want to inject themselves, and insurers put up obstacles to paying, cardiologists say. The drugs’ list prices are more than $500 a month.”
  • STAT News adds,
    • “A cholesterol-lowering injection that’s been on the market for nearly a decade has now shown its power to cut cardiovascular events in people considered at high risk but who haven’t yet suffered a heart attack or stroke.
    • “A study published Saturday in the New England Journal of Medicine and presented here at the American Heart Association’s scientific sessions concluded that Repatha reduced coronary heart disease death, heart attack, and stroke by 25% overall and lowered first heart attacks by 36% in people with high cholesterol but no history of these serious events. Their high cholesterol meant they were already taking statins or other cholesterol-lowering medications.
    • “Repatha, made by Amgen, also reduced cardiovascular problems and prevented the need for stent and bypass procedures, meeting both endpoints of the clinical trial called VESALIUS-CV. That’s better than statin therapy, an older class of cholesterol-lowering drugs that became the best-selling medicines in the world.” 
  • The Washington Post informs us,
    • “One of the largest studies ever conducted on the link between the shingles vaccine and brain health offers insight into how the disease increases dementia risk.
    • “People who experienced multiple episodes of shingles had a higher risk of dementia for several years after the second outbreak, the study found, compared with those who had it only once.
    • “The findings, published recently in the journal Nature Medicine, provide additional evidence for why getting vaccinated for shingles could help protect the brain.
    • “Shingles stems from the varicella-zoster virus, which causes childhood chickenpox and hibernates in the nervous system. As people age, the virus reactivates but often is “beaten back down by the immune system,” said Pascal Geldsetzer, a professor of medicine at Stanford University and one of the study’s authors. But sometimes, he said, “it reactivates fully” and then you get shingles’ telltale symptoms, the burning, tingling, painful blisters and rash.”
  • Per Medscape,
    • “Continuous glucose monitoring (CGM) may be appropriate and potentially beneficial for patients undergoing dialysis, especially those with diabetes, according to a prospective community-based cohort study.
    • “The findings, published in the Journal of the American Society of Nephrology, demonstrated that in maintenance dialysis, CGM frequently identified episodes of hyperglycemia and hypoglycemia that may not be clinically evident.
    • “The authors noted that while CGM provides detailed glycemic profiles, few studies have evaluated its use in patients with kidney failure, with most limited to small or selective cohorts. They sought to address this by designing a study that characterized the spectrum of glycemia and its determinants in a large, demographically diverse population of patients receiving maintenance dialysis.”

From the U.S. healthcare business front,

  • BioPharma Dive confirms,
    • “Metsera has abandoned a deal with Novo Nordisk in favor of a new acquisition offer from Pfizer, ending a high stakes fight between two large pharmaceutical companies over ownership of a coveted maker of obesity drugs. 
    • “Under terms of a deal announced late Friday, Pfizer will acquire Metsera for up to $86.25 per share, or more than $10 billion. Pfizer will pay $65.60 per share initially and could add up to $20.65 per share more in “contingent value right” payouts tied to specific milestones. 
    • “Metsera’s board has thrown its support behind the new deal, arguing Pfizer’s proposal is now in shareholders’ best interests both because of its “value and certainty of closing.” In doing so, it rejected an unusual two-step bid from Novo Nordisk that alarmed the Federal Trade Commission and includes “unacceptably high legal and regulatory risks” comparatively. 
    • “Novo, in a separate statement, said it won’t make another bid and believes its latest offer complies with antitrust laws. Its decision to drop out of contention is “consistent with its commitment to financial discipline and shareholder value,” Novo said.”  

Cybersecurity Dive

David Ermer–Cybersecurity, Generative AI, Uncategorized–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “Congressional leaders are pressing federal agencies to provide more information on their plans to compete with China on a range of tech and cybersecurity issues, including a strategy for promoting American 6G telecommunications infrastructure and limiting Chinese tech in US supply chains.
    • “Representative Raja Krishnamoorthi, D-Ill., ranking member on the House Select Committee on the Chinese Communist Party, wrote to Secretary of State Marco Rubio last week asking for an update on the department’s work building international coalitions around 6G.
    • “In the letter, dated Oct. 30 and shared exclusively with CyberScoop, he called for the department to share details on how it is fighting to shape international norms, global technical standards and supply chains in favor of U.S. and non-Chinese companies and technologies, saying “diplomacy can, and must, play a key role in this strategy.”
    • “While it remains essential that we continue to address the threats posed by the Chinese Communist Party’s efforts to dominate 5G, we must also look forward to how we can outcompete the CCP in the next frontier of wireless competition,” he wrote.”
  • HIPAA Journal tells us,
    • “Two U.S. nationals have recently been indicted for using BlackCat ransomware to attack targets in the United States. A third individual is suspected of involvement but was not included in the indictment. All three individuals worked at cybersecurity companies and conducted the attacks while they were employed there.
    • “Ryan Clifford Goldberg was employed by the cybersecurity firm Sygnia as an incident response professional, and Kevin Tyler Martin and an unnamed co-conspirator were both employed by the Chicago-based cyber threat intelligence and incident response firm DigitalMint as ransomware threat negotiators.
    • “The two indicted individuals are alleged to have engaged in a conspiracy to enrich themselves by breaching company networks, stealing their data, using ransomware to encrypt files, and extorting the companies to obtain cryptocurrency payments. A medical device company was attacked on or around May 13, 2023, resulting in a $10 million ransom demand.  The medical device company negotiated and paid a $1,274,000 ransom payment.
    • “A pharmaceutical company was also attacked in May 2023, but the ransom demand was not disclosed. Then came a July 2023 attack on a doctor’s office in California, which included a $5,000,000 ransom demand. In October 2023, an engineering company was attacked and told to pay $1 million, then in November 2023, a drone manufacturer in Virginia was attacked, and the defendants allegedly demanded a $300,000 ransom payment. Only the medical device company paid the ransom.”
  • Cyberscoop adds,
    • “A 25-year-old Russian national pleaded guilty to multiple charges stemming from their participation in ransomware attacks and faces a maximum penalty up to 53 years in prison.
    • “Aleksei Olegovich Volkov, also known as “chubaka.kor,” served as the initial access broker for the Yanluowang ransomware group while living in Russia from July 2021 through November 2022, according to court records. Prosecutors accuse Volkov and unnamed co-conspirators of attacking seven U.S. businesses during that period, including two that paid a combined $1.5 million in ransoms. 
    • “The victims, which included an engineering firm and a bank, said executives received harassing phone calls and their networks were hit with distributed denial of service attacks after their data was stolen and encrypted by Yanluowang ransomware operators.”

From the cybersecurity breaches and vulnerabilities front,

  • Cyberscoop reports,
    • “A federal agency that supplies budget and economic information to Congress has suffered a cybersecurity incident, reportedly at the hands of a suspected foreign party.
    • “A spokesperson for the Congressional Budget Office (CBO) acknowledged the incident Thursday [November 6] after The Washington Post reported that the office was hacked, with the attackers potentially accessing communications between lawmakers and researchers at the agency.
    • “The Congressional Budget Office has identified the security incident, has taken immediate action to contain it, and has implemented additional monitoring and new security controls to further protect the agency’s systems going forward,” said the CBO spokesperson, Caitlin Emma.” 
  • and
    • “SonicWall said a state-sponsored threat actor was behind the brute-force attack that exposed firewall configuration files of every customer that used the company’s cloud backup service. 
    • The vendor pinned the responsibility for the attack on an undisclosed nation state Tuesday, after Mandiant concluded its investigation into the incident.
    • “SonicWall did not attribute the attack to a specific country or threat group and Mandiant declined to provide additional information. The vendor’s update, which lacked a root-cause analysis, was mostly an effort to put the attack behind it as leadership made pledges to improve SonicWall’s security practices.”
  • The Cybersecurity and Infrastructure Security Agency added two known exploited vulnerabilities to its catalog this week.
    • November 4, 2025
      • CVE-2025-11371 Gladinet CentreStack and Triofox Files or Directories Accessible to External Parties Vulnerability
      • CVE-2025-48703 CWP Control Web Panel OS Command Injection Vulnerability 
        • The Hacker News discusses these KVEs here.
  • Cybersecurity Dive informs us,
    • “Critical flaws in Microsoft Teams can be used to allow an attacker to manipulate messages, spoof notifications and even impersonate executives, according to a report released Tuesday by Check Point Research. 
    • ‘Researchers found four vulnerabilities that allow attackers, including external hackers and malicious insiders, to manipulate Teams messages, conduct business email compromise or forge identities in video calls or phone messages. 
    • “Researchers found that attackers could conduct four specific types of attacks:
      • “Attackers could edit Teams messages without leaving the “edited” label behind in the message.
      • “Message notifications could be manipulated so that they appeared to be from another sender. 
      • “Attackers could change the display name inside private chats.
      • “Caller identities could be altered in video and audio calls.” 
  • and
    • “A critical vulnerability in Cisco IOS XE is being exploited to install an implant called BadCandy in a renewed wave of attacks, according to warnings from Australian government authorities and multiple security researchers. 
    • “State-linked and criminal hackers have been abusing the vulnerability, tracked as CVE-2023-20198, to install BadCandy in targeted systems since 2023, and have periodically renewed those attacks in waves.” * * *
    • “Shadowserver Foundation on Monday warned that threat activity is widespread across the globe, with more than 15,000 devices with backdoor implants remaining visible.”
    • “The vulnerability, tracked as CVE-2023-20198, abuses the web user interface in Cisco IOS XE software and has a severity score of 10. It was previously disclosed as a zero-day in 2023, with more than 42,000 devices exploited.” 
       
  • Security Week lets us know,
    • “ClickFix attacks continue to evolve and the technique appears to be increasingly used against macOS users, with lures becoming ever more convincing. 
    • “ClickFix has been widely adopted by both profit-driven cybercriminals and state-sponsored threat groups. 
    • ‘The social engineering tactic enables attackers to trick victims into inadvertently executing malicious commands, particularly ones that lead to the deployment of malware. 
    • “An attack involves a fake error message being displayed, informing the targeted user that in order to ‘fix’ the issue they need to click on a button and execute a series of operations. 
    • “When the user clicks the ‘fix’ or ‘verify’ button in the prompt, a malicious command is copied in the background to their clipboard. 
    • ‘On Windows, the victim is then instructed to press the Windows+R keys, which opens the Windows Run dialog box, then press Ctrl+V, which pastes the malicious command from the clipboard into the box, and finally press Enter to execute the command. The command typically runs silently in the background (often by leveraging a legitimate Windows utility such as PowerShell), downloading and installing a piece of malware.”
  • Per Cybersecurity Dive,
    • “Energy, healthcare, government and transportation saw the biggest surges in cyberattacks targeting Android devices between June 2024 and May 2025, the security firm Zscaler said in a report published on Wednesday.
    • “Agriculture, IT and education saw some of the biggest drops in attacks on Android devices, according to the report.
    • “Manufacturing, which also saw a significant increase in 2025, accounted for 26% of all cyberattacks on Android devices that Zscaler tracked.”
  • and
    • “Identity-related risks are the biggest danger facing enterprises’ cloud environments, according to a report that ReliaQuest published on Tuesday.
    • “Forty-four percent of valid alerts from cloud security tools “were rooted in identity-related weaknesses,” ReliaQuest said, while 33% of all alerts related to identity.
    • “Hackers prefer identity-based attacks because they rely on credentials available for cheap on the dark web, they can evade many detection tools and there are so many identities ripe for impersonation, according to the report.”
  • and
    • “Cyber threat actors have recently begun using AI to develop malware, in a dramatic evolution of the technology’s role in the hacking ecosystem, Google said on Wednesday.
    • “New strains of malware use AI to grow and change in real time during the attack phase, potentially making detection and defense much more difficult, Google’s threat intelligence researchers said in a report.
    • “The recent trend represents the latest phase in an AI arms race between attackers and defenders.”
  • Help Net Security adds,
    • “Security leaders are staring down a year of major change. In its Cybersecurity Forecast 2026, Google paints a picture of a threat landscape transformed by AI, supercharged cybercrime, and increasingly aggressive nation-state operations. Attackers are moving faster, scaling their operations with automation.
    • “By 2026, AI will be a normal part of everyday attack and defense activity. Adversaries are already using it to automate phishing, clone voices, and shape disinformation.
    • “One of the fastest-growing threats is prompt injection, which manipulates AI systems to ignore safeguards and carry out hidden commands. As more companies deploy LLMs inside business processes, these attacks are becoming easier to launch and harder to detect.” * * *
    • “The report notes a growing reliance on AI agents, systems that act on their own to complete tasks. These agents will need distinct digital identities and strict access controls. Security programs built for human users will not be enough. Identity management will have to account for AI-driven decision making and temporary task-based privileges.
    • “AI is also reshaping security operations. Analysts will soon direct AI tools rather than manually sort through alerts. Instead of reviewing logs, they will examine case summaries and confirm automated containment steps. This shift enables faster response but also brings new oversight challenges.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “An August ransomware attack against the state of Nevada has been traced to a May intrusion, when a state employee mistakenly downloaded a malware-laced tool from a spoofed website, according to a forensic report the state released Wednesday.
    • “State officials refused to submit to a ransom demand and recovered 90% of the impacted data after a 28-day recovery period. The state had insurance coverage and pre-negotiated vendor agreements, which factored into the decision not to pay a ransom. 
    • “The threat actor deployed an attack aimed at taking state systems offline and left behind a note with instructions on how to recover the encrypted systems and data, in an attempt to extort the state,” Timothy Galluzzi, chief information officer and executive director of the Governor’s Technology Office, said in the report.” * * *
    • “The threat actor, whom the report did not identify, gained access to more than 26,400 files. Another 3,200 files were left exposed across multiple systems. The state incurred about $1.3 million in expenses related to recovery costs, as they engaged several major companies to help investigate and restore agency services, including Mandiant, Dell, Microsoft DART, Palo Alto Networks, Aeris and other firms.” 
  • TechCrunch informs us,
    • “The Washington Post has said that it was one of the victims of a hacking campaign tied to Oracle’s suite of corporate software apps.  
    • “Reuters first reported the news on Friday [November 7], citing a statement from the newspaper that said it was affected “by the breach of the Oracle E-Business Suite platform.” 
    • “A spokesperson for the Post did not immediately respond to TechCrunch’s request for comment.” * * *
    • “On Thursday [November 6], Clop claimed on its website that it had hacked The Washington Post, claiming that the company “ignored their security,” language that the Clop gang typically uses when the victim does not pay the hackers. 
    • “It’s not uncommon for ransomware or extortion gangs like Clop to publicize the names and stolen files of their victims as a pressure tactic, which can suggest that the victim has not negotiated a payment with the gang, or the negotiation broke down. 
    • ‘Several other organizations have confirmed they are affected by the Oracle E-Business hacks, including Harvard University and American Airlines subsidiary Envoy.”
  • The Hackers News tells us,
    • “Cybersecurity researchers have flagged a malicious Visual Studio Code (VS Code) extension with basic ransomware capabilities that appears to be created with the help of artificial intelligence – in other words, vibe-coded.
    • Secure Annex researcher John Tuckner, who flagged the extension “susvsex,” said it does not attempt to hide its malicious functionality. The extension was uploaded on November 5, 2025, by a user named “suspublisher18” along with the description “Just testing” and the email address “donotsupport@example[.]com.”
    • “Automatically zips, uploads, and encrypts files from C:\Users\Public\testing (Windows) or /tmp/testing (macOS) on first launch,” reads the description of the extension. As of November 6, Microsoft has stepped in to remove it from the official VS Code Extension Marketplace.
  • Tech Radar points out,
    • “[Ransomware gang] Rhysida spoofed Microsoft Teams ads on Bing to deliver malware via fake download pages
    • “Victims received OysterLoader and Latrodectus, which deploy ransomware, backdoors, and infostealers
    • “Group operates on RaaS model; past targets include airports, libraries, and U.S. school districts.”

From the cybersecurity business and defenses front,

  • Cyberscoop reports,
    • “Cloud security company Zscaler [November 3] announced Monday it has acquired SplxAI, an artificial intelligence security platform, in a move to strengthen its ability to protect enterprise AI assets.
    • “Terms were not disclosed. 
    • “Zscaler said the purchase is aimed at enhancing its zero-trust security offerings by integrating Splx’s technology for AI asset discovery, automated red-teaming, and governance. The company said these features will help secure AI applications and services during development and after deployment.
    • “AI is creating enormous value, but its full potential can only be realized when it can be secured,” Zscaler CEO Jay Chaudhry said in a statement.”
  • Security Week adds,
    • “Google and Wiz said the antitrust review initiated by the United States Department of Justice into their planned $32 billion acquisition has been cleared.
    • “The companies announced reaching an agreement on the terms of an acquisition in March 2025. 
    • “News of a Justice Department antitrust review into Google’s planned acquisition of the cloud security giant came to light in mid-June. The goal of the probe was to determine whether the deal would harm competition in the cybersecurity market.
    • “During the recent WSJ Tech Live California event, Wiz CEO Assaf Rappaport confirmed that his company had cleared the regulatory hurdle, noting they are “still in the journey between signing and closing.”
  • Dark Reading offers a commentary about “Closing the AI Execution Gap in Cybersecurity — A CISO Framework. CISOs must navigate five critical dimensions of AI in cybersecurity: augmenting security with AI, automating security with AI, protecting AI systems, defending against AI-powered threats, and aligning AI strategies with business goals. Neglecting any of these areas is a recipe for disaster.”
  • Here’s a link to Dark Reading’s CISO Corner.