Monday report

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

From Washington, DC,

  • Govexec reports,
    • “As the Senate continues to take failed votes to reopen the government, the chamber will soon shift to a new approach that would ensure on-time for feds working during the shutdown. 
    • “In its 20th day, Senate Democrats were expected to reject for the 11th time a short-term spending measure to fund agencies through Nov. 21. Senate Republicans are looking to ramp up pressure on Democrats by allowing normal paychecks for employees required to continue reporting to their jobs without immediate compensation during the shutdown. 
    • “Senate Majority Leader John Thune, R-S.D., told reporters he would on Monday evening take the first procedural step to bring the measure up for consideration, with a vote taking place either Wednesday or Thursday. 
    • “They’re all going to get paid eventually, but I think people who are working right now and not getting paid ought to be,” Thune said.” 
  • Before Congress overrides it, here’s a link to OPM’s 89-page long Guidance on Shutdown Furloughs, which the FEHBlog ran across today.
  • Kevin Moss, writing in Govexec, discusses “what FEHB changes mean for your 2026 health coverage. Premiums are shifting, and the government contribution varies. Here’s what to know to avoid surprises and save where you can.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has approved Rybelsus, Novo Nordisk’s oral semaglutide formulation, for reducing the risk of major adverse cardiovascular events in high-risk patients with type 2 diabetes. Rybelsus is officially the first oral GLP-1 drug approved for this indication.
    • “The FDA’s decision was largely based on data from the SOUL trial, which included data from more than 9,000 patients who were randomized to oral semaglutide or a placebo.[1] All patients had type 2 diabetes in addition to known atherosclerotic cardiovascular disease, chronic kidney disease or both. Overall, the study’s primary outcome—a composite of cardiovascular death, nonfatal heart attack or nonfatal stroke—was seen in 12% of oral semaglutide patients and 13.8% of placebo patients. This represents a 14% overall reduction, similar to the results associated with injectable semaglutide.
    • “The FDA originally approved Rybelsus in 2019 to improve glycemic control in adults with type 2 diabetes. At the time, it was the celebrated as the first GLP-1 drug available in pill form—and it still is six years later.”
  • Fierce Pharma adds,
    • “With the lupus treatment landscape poised for a shake-up, Roche is hitting the scene in the U.S. with a new green light for its long-approved blood cancer medicine Gazyva.
    • “Early Monday, Roche’s Genentech announced that the FDA cleared Gazyva (obinutuzumab) to treat adults with active lupus nephritis who are taking standard therapy.
    • “The drug will be given as four initial infusions during the first year of treatment, after which it can be administered twice yearly.” 
  • Per MedTech Dive,
    • “Ōura is pursuing Food and Drug Administration clearance of a blood pressure feature for its smart rings.
    • “Having engaged with the FDA, Ōura has received approval to study the feature in a population of users who are signed up to try experimental features of its devices, the company said Monday. 
    • “Participants will answer health questions. By combining the answers with data from the user’s ring, Ōura will assess the likelihood of the patient having high blood pressure.”

From the public health and medical / Rx research front,

  • The Washington Post reports on “four surprising things that may reduce your risk of Parkinson’s. Research on Parkinson’s is revealing several risk factors related to our lifestyles and environment, and you can act on some of them.”
    • “Parkinson’s disease, once considered relatively rare, is now one of the most common neurological disorders in the world, and the second most common after Alzheimer’s disease. The number of people living with Parkinson’s has more than doubled in the past 25 years to 8.5 million and is predicted to hit 25.2 million by 2050.”
    • “The hallmark symptoms of Parkinson’s — such as tremors, stiffness, and difficulty with balance and coordination — result from the deterioration of neurons in the basal ganglia, an area of the brain that controls movement. While 10 to 15 percent of cases are linked to inherited genetic mutations, the rest are considered “sporadic,” with no known cause.
    • “Although treatments are available that can manage symptoms, there is no cure or therapy that can slow disease progression. But ongoing research on Parkinson’s is revealing several risk factors related to our lifestyles and environment, some of which are actionable.
    • “For example, moderate to vigorous exercise may reduce one’s risk, according to a 2018 meta-analysis, and some studies have shown that healthy diets focused on whole, unprocessed foods might help. Last year, a study found that higher levels of exposure to air pollution were associated with an increased risk of Parkinson’s.”
    • The article offers more tips.
  • The New York Times points out,
    • For the first time, researchers restored some vision to people with a common type of eye disease by using a prosthetic retinal implant. If approved for broader use in the future, the treatment could improve the lives of an estimated one million, mostly older, people in the United States who lose their vision to the condition.
    • The patients’ blindness occurs when cells in the center of the retina start to die, what is known as geographic atrophy resulting from age-related macular degeneration. Without these cells, patients see a big black spot in the center of their vision, with a thin border of sight around it. Although their peripheral vision is preserved, people with this form of advanced macular degeneration cannot read, have difficulty recognizing faces or forms and may have trouble navigating their surroundings.
    • In a study published Monday in The New England Journal of Medicine, vision in 27 out of 32 participants improved so much that they could read with their artificial retinas.
  • The American Medical Association lets us know what doctors wish their patients knew about menopause.
  • Healio tells us,
    • “Exposure to elevated blood pressure through young adulthood was linked to cognitive decline by midlife.
    • “The trend was consistent across race and sex subgroups.”
  • NBC News reports,
    • “With age comes a natural decline in cognitive function, even among otherwise healthy adults without dementia. A new study finds that a cognitive training program may boost production of a brain chemical that plays a role in memory and attention.
    • “Participants who completed game-like activities through BrainHQ, an online subscription program, showed increased production of acetylcholine, sometimes called the “pay attention” chemical. The process that produces acetylcholine in the brain is called the cholinergic system.”
  • Per MedPage Today,
    • “Having shingles boosted the risk of major adverse cardiovascular events (MACE) such as vascular dementia, heart attack, stroke, and death by roughly a quarter — but people who received the recombinant shingles vaccine before developing shingles saw their risks of those outcomes drop by up to half, according to a large retrospective study.
    • “Among more than 174,000 people, ages 50 or older, those who developed a herpes zoster infection were approximately 20% more likely to have a heart attack, 27% more likely to have a stroke, and up to 30% more likely to die than people who didn’t develop shingles, reported Ali Dehghani, DO, of Case Western Reserve University in Cleveland.
  • and
    • “Visceral and liver fat were tied to carotid atherosclerosis in two cohort studies using MRI and ultrasound imaging.
    • “Associations persisted even after accounting for traditional cardiovascular risk factors like cholesterol and blood pressure.
    • “Study authors encourage a healthy diet as a way reduce visceral fat and therefore manage the risk of cardiovascular disease.”
  • Per Genetic Engineering and Biotechnology News,
    • “In a new study published in Cancer Cell titled, “Tumor-infiltrating bacteria disrupt cancer epithelial cell interactions and induce cell-cycle arrest,” researchers from the University of Texas MD Anderson Cancer Center have discovered a previously unknown mechanism that explains how bacteria can drive treatment resistance in patients with oral and colorectal cancer. 
    • “While tumor-infiltrating bacteria have been known to impact cancer progression and treatment, the mechanism has been unclear. Results demonstrate how the bacteria, Fusobacterium nucleatum (Fn), can induce a reversible state, known as quiescence, in cancer epithelial cells to allow tumors to evade the immune system and resist chemotherapy. 
    • “These bacteria-tumor interactions have been hiding in plain sight, and with new technologies we can now see how microbes directly affect cancer cells, shape tumor behavior and blunt the effects of treatment,” said Susan Bullman, PhD, associate professor of Immunology and associate member of MD Anderson’s James P. Allison Institute and corresponding author of the study. “It’s a whole layer of tumor biology we’ve been missing and one we can now start to target. We hope these findings help open the door to designing smarter, microbe-aware therapies that could make even the toughest cancers more treatable.” 

From the HLTH Conference,

  • Modern Healthcare tells us,
  • Healthcare Dive informs us,
    • “Online pharmacy Cost Plus Drugs will be participating in President Donald Trump’s drug price transparency tool, TrumpRx, according to Cost Plus’ founder Mark Cuban.
    • “Cuban shared the news during his keynote at the HLTH conference on Sunday, during which the billionaire entrepreneur and pharmacy disruptor also excoriated the pharmacy benefit manager industry for driving up the cost of U.S. medications.”
  • Per Fierce Healthcare,
    • “At the 2025 HLTH conference in Las Vegas, GE HealthCare unveiled health system partnerships and the latest research projects that are part of its AI Innovation Lab. 
    • “The company is working with the Queen’s Health Systems in Honolulu and Duke Health in Durham to advance the development of its new AI-driven hospital operations software, which will become part of CareIntellect.
    • “CareIntellect, a generative AI platform, is a hub for various GE HealthCare applications and was first announced at HLTH last year. The idea is to enable health systems to easily deploy new applications without a product-by-product integration approach. 
    • “Now you can really have a common data layer, that’s all the data is structured in a way that you can analyze and plug into. You can bring more applications, whether that’s on the operations side, on the care delivery side,” Taha Kass-Hout, GE HealthCare’s global chief science and tech officer, told Fierce Healthcare.”
  • and
    • WeightWatchers is joining forces with Amazon Pharmacy to make it easier for members to access weight management medications.
    • The company announced Monday that through the partnership its members will be able to access information on real-time medication availability, automated coupon savings and home delivery for key medications they use to manage their weight.
    • Amazon Pharmacy will automatically apply coupons for members at the point of checkout, according to an announcement, without the need to submit codes manually. Amazon Prime members have access to two-day home delivery, and in certain locations same-day delivery is available as an option.
    • Scott Honken, chief commercial officer for WeightWatchers, told Fierce Healthcare that the team has had a longstanding relationship with Amazon, but tapping into its pharmacy unit made sense as it looked to improve access and ease for members.
  • and
    • “Artificial intelligence startup OpenEvidence banked $200 million in series C funding, just three months after it raised $210 million in a series B.
    • “The three-year-old company’s valuation hit $6 billion post-series C raise, Daniel Nadler, Ph.D., one of OpenEvidence’s founders confirmed to Fierce Healthcare on Monday. OpenEvidence developed an AI-powered medical search engine and generative AI chatbot exclusively for doctors that summarizes and simplifies evidence-based medical information. 
    • “The New York Times first reported the series C funding Monday morning.
    • “OpenEvidence has raised nearly $500 million since its founding in 2022. Google Ventures led the round. Existing investors Sequoia, Kleiner Perkins, Thrive and Coatue backed the series C. New investors BOND (Mary Meeker), Blackstone and Craft also joined the round.
    • “The company offers its chatbot to physicians for free, and the product has grown organically through word of mouth between doctors, Nadler said.
    • “OpenEvidence plans to use the fresh funding to continue building out its AI technology.”
  • and
    • “Highmark is teaming up with Noom to roll out its weight management solution to members.
    • “Eligible members can enroll in the program and will receive Noom’s services at no cost. Their care journeys can be personalized to meet their individual needs and generally follow three tracks: weight loss and management, diabetes prevention and management.
    • “Maria Baker, vice president for health strategy and delivery at Highmark, told Fierce Healthcare that the partnership with Noom reflects the insurer’s broader commitment to whole-person health, as a holistic weight management program is a logical place to start filling in key gaps in members’ experiences.
    • “The healthcare industry can forever try to make people come to us and think about our language, or we can meet people where they are,” she said. “And one of the best ways to do that is to meet people in a language they understand, and through a door that people are always talking about.
    • “So the weight journey was the most logical place to start,” Baker said.”
  • and
    • “Knownwell picked up $25 million in fresh funding, riding the wave of investment in obesity care.
    • “CVS Health Ventures led the round with participation from MassMutual Catalyst Fund and Intermountain Ventures.
    • “Existing investors a16z Bio + Health and Flare Capital Partners also backed the oversubscribed financing round. The company has raised a total of $50 million to date, with a $20 million round in late 2023.
    • “The startup offers in-person and virtual services as a weight-inclusive primary care and metabolic health company. Knownwell offers broader services beyond just weight management or GLP-1 prescriptions to include nutrition counseling and behavioral health services both online and in person.”

From the U.S. healthcare business front,

  • Beckers Oncology notes,
    • “Philadelphia-based Penn Medicine and Penn Medicine Princeton (N.J.) Health will break ground on a $401 million cancer center Oct. 20 at the Princeton Medical Center in Plainsboro, N.J.
    • “The Penn Medicine Princeton Cancer Center is expected to open in May 2028, according to a Penn Medicine news release.
    • “The center will house more than 40 exam rooms, 30 infusion chairs, two linear accelerators for radiation therapy and a breast imaging center.
    • “Care teams at the cancer center will work with experts from the Penn Medicine Abramson Cancer Center. Patients will also have access to clinical trials and services such as proton therapy and personalized cell therapies through other Penn Medicine care sites, the release said.”
  • Per Fierce Pharma,
    • “Merck has kicked off construction of a new $3 billion facility at its sprawling manufacturing campus in Elkton, Virginia. The investment is part of the New Jersey company’s plan to spend more than $70 billion on manufacturing, R&D and capital projects in the U.S., it announced Monday.
    • “The planned 400,000-square-foot facility will add to Merck’s presence at the massive site at the base of the Blue Ridge Mountains in Virginia’s Shenandoah Valley. The complex already covers 1.2 million square feet and employs more than 1,000.
    • “With the investment spanning active pharmaceutical ingredient and drug product functions, the new plant will support small-molecule production and testing, Merck said. The facility, dubbed as its Center of Excellence for small-molecule manufacturing, could create more than 500 full-time jobs, according to the company.”
  • Modern Healthcare relates,
    • “Hartford HealthCare said Monday it won a bid to purchase two Connecticut hospitals from bankrupt Prospect Medical Holdings. The deal, which is subject to court approval, involves Manchester Memorial Hospital and Rockville General Hospital.” 
  • and
    • “Humata Health will provide its prior authorization automation tool through Microsoft’s generative artificial intelligence assistant, Dragon Copilot.
    • “Microsoft launched Dragon Copilot in March to assist clinicians with documentation, revenue cycle management, patient engagement and decision support. 
    • “The integration will enable clinicians to automate and complete prior authorizations within their workflows, a Humata spokesperson said Monday. Microsoft will determine when the tool will be available through Dragon Copilot, and Humata is discussing the capability with customers, the spokesperson said.”
  • BioPharma Dive lets us know,
    • “The share price of Alto Neuroscience more than doubled at one point Monday, after the psychiatry drug specialist announced plans to hasten the development of a potential depression medicine.
    • “This medicine, code-named ALTO-207, combines a drug already used to treat Parkinson’s disease with the active ingredient in the nausea medication Zofran. Alto got ahold of ALTO-207 this spring, when, for less than $2 million, it bought a slate of experimental, dopamine-boosting drugs from Chase Therapeutics. In unveiling that deal, Alto said it intends to start, by the middle of next year, a mid-stage clinical trial that could serve as the foundation for ALTO-207 getting approved in treatment-resistant depression.
    • “Now, encouraged by a recent meeting with the Food and Drug Administration, the company also wants to initiate a late-stage study by early 2027.”
  • Per Fierce Healthcare,
    • “Humana and Providence on Monday unveiled a new data exchange partnership the major payer and provider said could become a blueprint for the broader industry.
    • “The data sharing ecosystem is slated to go live later this month in an initial rollout focused on automating member attribution for Humana Medicare Advantage members, which the companies said will help the 51-hospital system’s providers understand which patients are considered by Humana to be under their care.
    • “Additional capabilities on the data exchange collaboration’s road map will focus on reducing administrative burden and bolstering clinical decision-making, they said.
    • “The healthcare industry is overwhelmed by fragmented, inconsistent data formats that make care coordination costly and slow,” Michael Westover, vice president of population health informatics at Providence, said in the announcement. “Because we want to be successful in value-based care contracts, Humana and Providence are building a shared foundation of administrative, financial and clinical data using national standards and modern technology.”
    • “More specifically, the pair said they’re using HL7 Fast Healthcare Interoperability Resources (FHIR), Da Vinci Project Implementation Guides and other “modern” application programming interfaces (APIs) to build out their infrastructure.
    • “That framework “will be easily replicable, serving as a scalable model that can transform care across the healthcare industry,” they said.”
  • Per an Institute of Clinical and Economic Review news release,
    • “Today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions. * * *
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on November 17, 2025.”