Monday report

Obesity

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.”

Friday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) proposed extending expiring healthcare subsidies for one year as part of a measure to reopen the government, in a move aimed at breaking the monthlong logjam.
    • “Under Schumer’s plan, which he has shared with Senate Democrats, lawmakers would then establish a bipartisan commission to devise changes to the Affordable Care Act, which Republicans have demanded as they seek to rein in federal healthcare spending.
    • “After so many failed votes, it’s clear we need to try something different,” Schumer said. After he spoke, Sen. Tammy Baldwin (D., Wis.) and other Democrats who had rejected a Republican-backed bill to fund the government through Nov. 21 said they could support the approach.
    • “But Senate Republicans quickly rejected the idea and said the offer was a sign that Democrats were caving. GOP lawmakers stuck to their position that negotiations on the subsidies could only occur after Democrats vote to end the shutdown. Democrats had originally sought a permanent extension of the subsidies, at a 10-year cost of roughly $350 billion.”
  • The Senate considered S. 3012, Senator Ron Johnson’s (R WI) bill to pay federal employees during this and any future shutdown. The bill failed to reach the 60 votes required for cloture (53 i favor and 43 opposed). The Senate adjourned at 6:45 pm ET and will resume it floor business tomorro at noon ET.
  • Federal News Network interviews NARFE Staff Vice President John Hatton about the Federal Benefits Open Season which begins next Monday. These comments from Mr. Hatton caught the FEHBlog’s eye:
    • “Terry Gerton: I’m speaking with John Hatton. He’s staff vice president of the National Association of Active and Retired Federal Employees. John, let’s come back to the OPM plans. They made some changes to default plans for folks whose coverage is going away. What do people need to know if they’re looking at an automatic enrollment? How is that process going to play out and what if it doesn’t fit their needs?
    • “John Hatton: Yeah, anytime your plan is dropping out, you’re defaulted into a different plan. So you don’t totally lose coverage. You don’t have to make an affirmative choice. That’s a good positive thing. This year, the NALC plan is dropping out of the federal side of the program. They’re still on the postal side. So if you’re a postal employee or retiree, you can still retain it. But that’s a significant number of people. OPM made the choice to not default into the lowest cost nationwide plan without a high deductible and without an association membership fee. That’s what the regulation says. Then it has another sentence that says they reserved the right to designate an alternate plan for automatic enrollments. So this year, the lowest cost nationwide plan would be the GEHA Elevate plan, but instead, they have designated the GEHA High plan. So in the past, you would be automatically enrolled into a low-premium plan. In this case, you’re automatically enrolled into a high-premium plan. So particularly if you had a consumer option in NALC, for example, you’re going to see a huge spike in increases if you just defaulted in and you don’t make an alternative choice. So we really encourage people to choose. I mean, maybe the high premium plan with more coverage is the right choice for you, but you may want to look at some other alternative plan, even with those low deductibles that might be cheaper because there are options, even with really low deductible plans that have lower premiums and kind of the main big dogs in the program. So really critical that you look and choose what’s best for you.”
  • OPM Director Scott Kupor posted the latest entry in his Secrets of OPM blog. The post concerns change to OPM’s process for making automatic interim annuity payments to retiree applicants. The Director concludes
    • “About 75% of retiree applicants are currently receiving automatic interim pay. This is up from 30-40% under our old process, and our goal is for 100% of retiring federal workers to receive that interim payment within 30 days as they wait for their application to be processed. We do that by taking this measured risk. Questioning old habits, comparing downside risk to upside opportunity is a mindset we are developing at OPM. It’s part of how we modernize: not just with new technology, but with new thinking.
    • “We recently published a new FAQ for retirees that explains what we’re doing to improve the retirement process as we prepare for a surge in applications. And as of last month, retirees can now track their retirement via the Retirement Processing Times page on the OPM website. It’s one more way we’re putting transparency and service at the center of everything we do.
    • “Sometimes progress means changing how we think about risk. And if that means moving a little faster to get people what they’ve earned, then that’s a risk worth taking. No more fighting the last battle.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has announced a new recall for the Tandem Mobi Insulin Pump from California-based Tandem Diabetes Care. 
    • “The battery-operated Tandem Mobi Insulin Pump can provide users with long-acting basal insulin doses or short-acting bolus insulin doses. It delivers insulin from a disposable cartridge, through an infusion set and into the patient’s tissue.
    • “The recall was put in place due to a possible software malfunction that could interfere with the delivery of insulin. According to the FDA, if this failure occurs, it could result in patients developing hyperglycemia.
    • “Unlike many recalls, this is not a product removal. However, the FDA has still determined this is a Class I recall, which means there is a risk of serious injuries or even death if customers do not follow company recommendations. 
    • “This recall covers nearly 18,000 insulin pumps distributed throughout the United States. The devices do not need to be returned, but Tandem Diabetes Care is urging customers to update their pump software immediately. The newest version of the pump software is 7.9.0.2. Customers can use their Tandem Mobi Mobile App to confirm their software version and update it if necessary.”
  • BioPharma Dive lets us know,
    • “A study volunteer who’d received an experimental gene-editing treatment from Intellia Therapeutics in a Phase 3 trial has died, the company said in its Thursday earnings report. Intellia voluntarily paused dosing in that study as well as another late-stage trial in late October, when that patient was hospitalized due to a spike in liver enzyme and bilirubin levels. The Food and Drug Administration formally put the two studies on hold days later. Intellia is now suspending guidance for the program, nexiguran ziclumeran or nex-z, pending alignment with regulators. The incident “clearly” complicates the path forward for nex-z, “heightens the safety overhang” and puts Intellia’s broader transthyretin amyloidosis program “at risk,” wrote Leerink Partners analyst Mani Foroohar. Intellia shares, which have already lost about 40% of their worth in recent weeks, tumbled to less than $10 apiece early Friday.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Medicare is often seen as a universal safety net, a guarantee for older Americans that after decades of work — and having taxes withheld from their paychecks — the federal government will provide health insurance once they reach 65. But a new study found an increasing number of people are dying before they realize that promise.
    • “Premature deaths among 18-to-64-year-olds rose 27 percent, going from 243 to 309 deaths per 100,000 adults between 2012 and 2022, according to a study published Friday in JAMA Health Forum. Among Black adults, the study found the increase was about 10 percentage points higher compared to White adults.
    • “Medicare is often seen as a universal safety net, a guarantee for older Americans that after decades of work — and having taxes withheld from their paychecks — the federal government will provide health insurance once they reach 65. But a new study found an increasing number of people are dying before they realize that promise.
    • “Premature deaths among 18-to-64-year-olds rose 27 percent, going from 243 to 309 deaths per 100,000 adults between 2012 and 2022, according to a study published Friday in JAMA Health Forum. Among Black adults, the study found the increase was about 10 percentage points higher compared to White adults.”
    • Irene Papanicolas, a professor of health services, policy and practice at Brown University School of Public Health and lead author on the study, said it builds on two others she published earlier this year.
    • “One study found that preventable and treatable deaths — in which people younger than 75 whose deaths were driven by preventable conditions such as heart disease, substance-related deaths and chronic respiratory illness — increased in every U.S. state between 2009 and 2019. Meanwhile, such deaths are declining in 34 other high-income countries and increased in six, the study showed.”
    • “The other report, which was published in April in the New England Journal of Medicine, found that wealth generally confers health and longevity, with the richest Americans having about a 40 percent lower risk of death than the poorest. But those wealthy people in the United States still live shorter lives than Northern and Western Europeans who earn modest incomes or live in poverty, the study found.”
  • The AP relates,
    • “Doctor after doctor misdiagnosed or shrugged off Ruth Wilson’s rashes, swelling, fevers and severe pain for six years. She saved her life by begging for one more test in an emergency room about to send her home, again, without answers.
    • “That last-ditch test found the Massachusetts woman’s kidneys were failing. The culprit? Her immune system had been attacking her own body all that time and nobody caught it.
    • “I just wish there was a better way that patients could get that diagnosis without having to go through all of the pain and all of, like, the dismissiveness and the gaslighting,” she said.
    • “Wilson has lupus, nicknamed the disease of 1,000 faces for its variety of symptoms — and her journey offers a snapshot of the dark side of the immune system. Lupus is one of a rogues’ gallery of autoimmune diseases that affect as many as 50 million Americans and millions more worldwide – hard to treat, on the rise and one of medicine’s biggest mysteries.
    • “Now, building on discoveries from cancer research and the COVID-19 pandemic, scientists are decoding the biology behind these debilitating illnesses. They’re uncovering pathways that lead to different autoimmune diseases and connections between seemingly unrelated ones – in hopes of attacking the causes, not just the symptoms.
    • “While there’s still an enormous amount to learn, recent steps have some specialists daring to wonder if just maybe, ways to cure or prevent at least some of these diseases are getting closer.
    • “In dozens of clinical trials, scientists are harnessing some of patients’ own immune cells to wipe out wayward ones that fuel lupus and a growing list of other diseases. It’s called CAR-T therapy and early results with these “living drugs” are promising. The first lupus patient was treated in Germany in March 2021 and remains in drug-free remission, the researchers said last month.”
  • Per MedPage Today,
    • “Patients with plateaued weight loss or who reached their weight-related goals on a GLP-1 receptor agonist were able to maintain their improvements in weight, body composition, and metabolic improvements after they reduced the frequency of their dose, according to a recent case series. 
    • “Among 30 patients who reduced their dose frequency to anywhere between every 10 days to every 5-6 weeks, 26 of them remained at the weight they had reached before doing so, and some even lost another couple of pounds, Mitch Biermann, MD, PhD, from the Scripps Clinic Department of Internal Medicine and the Scripps Whittier Diabetes Institute in San Diego, reported at the ObesityWeek annual meeting.
    • “Patients also saw no subsequent worsening in blood glucose, lipids, blood pressure, or other metabolic measures, and some continued to improve. 
    • “My main conclusion is that, at least among patients that experience normalized metabolic syndrome parameters doing every week on these medications, if they are that type of successful patient, they’re likely to remain successful even if you reduce the frequency,” Biermann said. “The dose doesn’t have to be the maximum, and the frequency doesn’t even have to be every other week.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The long-acting monoclonal antibody nirsevimab (Beyfortus) protects children younger than 2 years from respiratory syncytial virus (RSV) infection for up to 1 year but may not do so beyond that period, suggests a large real-world study published yesterday in the Journal of Infection.
    • “The researchers, however, cautioned that the small sample size of children who received nirsevimab at least 12 months before may have limited the ability to detect significant results past 1 year.” * * *
    • “The findings have implications for scheduling repeat dosing in eligible children, the study authors said. “Currently, the second dose of nirsevimab for eligible children with high-risk comorbidities is often administered during the second season, with a minimum interval of 5–6 months,” they wrote. “In some regions, the RSV epidemic is year-round, where repeat dosing of nirsevimab at 5–6-month intervals can be costly.”
    • “The results need to be interpreted with caution owing to the inability to identify children whose mothers were vaccinated against RSV during pregnancy, potential missing documentation of nirsevimab administration, and residual confounding factors after propensity score matching. 
    • “The authors called for future studies on the long-term effectiveness of nirsevimab against RSV hospitalization, intensive care unit admission, and death.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “In a proof of concept that may reshape the treatment landscape for insulin-dependent diabetes, scientists have demonstrated that human stomach cells can be reprogrammed to secrete insulin—potentially paving the way for autologous cell-based therapies that eliminate the need for donor islets and systemic immunosuppression, as well as lifelong monitoring of blood sugar levels and insulin injections.
    • “The study, “Modeling in vivo induction of gastric insulin-secreting cells using transplanted human stomach organoids,” published in Stem Cell Reports and led by Xiaofeng Huang, PhD, of Weill Cornell Medicine and Qing Xia, MD, PhD, of Peking University, shows that human gastric tissue can be transformed in vivo into functional insulin-producing cells using a precision combination of defined genetic factors. The work builds on earlier findings in mice that the stomach’s cellular architecture can be coaxed into producing insulin and represents the first demonstration that this conversion can occur in human-derived tissues inside a living organism.”

From the U.S. healthcare business front,

  • The Wall Street Journal tells us about the founders of Metsera.
    • “Long before he found himself in the middle of a multibillion-dollar takeover battle for a coveted new weight-loss drug, Whit Bernard was a music nerd. He spent two years studying the role of musical activity in the nonviolent anti-Soviet uprisings of the Baltic States during the Perestroika era, publishing his research in English and Latvian. 
    • “After he got tired of working at a music nonprofit in Brooklyn, N.Y., he went to business school and became a consultant at McKinsey & Co. 
    • ‘His client was Clive Meanwell, a cancer researcher turned pharmaceutical executive who hired McKinsey to shore up costs and make other changes at his biotech Medicines Co. 
    • “The two hit it off, and Bernard left McKinsey to become Meanwell’s head of business development. They agreed to sell Medicines to Novartis for almost $10 billion in 2019, and looked to start another company. 
    • ‘Meanwell did what he does best—find the next big thing in medicine by looking for the biggest afflictions facing the most patients. Weight-loss drugs, he bet. Now, Bernard, 41, and Meanwell, 68, are about to pull off a big sale again. 
    • Pfizer PFE is locked in an unusually bitter fight to pay upward of $10 billion to buy Metsera MTSR and its stable of at least eight potential new drugs that can enter a global weight-loss market that analysts project will surpass $100 billion in 2030. 
    • The two stand to profit big from a transaction. Their firm Population Health Partners owns roughly 12% of Metsera shares, which would net it over $1 billion, assuming the final deal values Metsera at $10 billion or more.
  • Bloomberg adds,
    • “Pfizer Inc. has submitted a sweetened bid for obesity drug startup Metsera Inc. as its fight against rival Novo Nordisk A/S continues to escalate, according to people familiar with the matter.
    • “The new offer improves upon Pfizer’s earlier proposal for $86.20 a share including milestone payments, said the people, who asked not to be identified discussing private information. Pfizer’s revised bid on Friday is the latest in its back-and-forth with Novo, which submitted a proposal topping Pfizer’s for the second time on Thursday.
    • “Under the terms of its merger agreement, Pfizer will win even if the companies offer the same amount. The bidding war could continue with Novo increasing its offer, the people added.”
  • Per MedTech Dive,
    • “Synchron has raised $200 million to support commercialization of its brain computer interface platform, the company said Thursday.
    • “The Series D round will fund preparations to launch Synchron’s first-generation platform, which translates brain activity into digital commands without open-brain surgery, and development of a new interface.
    • “Synchron’s funding moves investment in BCI companies in 2024 and 2025 beyond $1 billion, with the round adding to financings at Blackrock Neurotech, Neuralink and Precision Neuroscience.”
  • Per Beckers Payer Issues,
    • “Baltimore-based Johns Hopkins is convening with health plans, health systems, policymakers and patients to further high-value care, according to a document shared with Becker’s on Nov. 7.
    • “The purpose of this convening proposal is to create sustainable improvements in healthcare value by aligning and synergizing the work of health systems, health plans and policymakers,” the grant application said. “We will bring together experts to collaboratively design meaningful metrics that increase quality, safety and value.” 
    • ‘The initiative, called Providers, Health Plans, Policymakers and Patients Aligned in Care Transformation, consists of three work groups. One will address hospital quality and process-based metrics, another will tackle ambulatory value-based care performance metrics and the third will focus on resource utilization management rules. Johns Hopkins Health Plan’s chief medical officer and associate chief medical officer are among the program’s leaders.”
  • Beckers Hospital Review offers a non-exhaustive list of “81 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2025,”
  • and informs us,
    • “Nearly 7 in 10 healthcare consumers will leave a review when texted or emailed, meaning a “passive reputation management strategy won’t cut it” for health systems, according to a Press Ganey report published Nov. 6. 
    • “Referrals historically defined a health system’s reputation, but now, reviews do.
    • “Press Ganey, a healthcare experience consulting firm, analyzed 6.5 million patient encounters across the U.S. and surveyed 1,000 healthcare consumers, which are defined as adults who researched healthcare providers online in the past year.”

From the artificial intelligence front,

  • Beckers Hospital Review shares the 10 best quotes on AI from Becker’s CEO + CFO Roundtable.
  • TechTarget reports,
    • “Recent headlines have warned that AI will decimate jobs and reshape work as we know it. But a new study from Yale University’s Budget Lab, “Evaluating the Impact of AI on the Labor Market: Current State of Affairs,” suggests the reality is less dramatic, at least for now.
    • “The study, conducted in partnership with the Brookings Institution, examined nearly three years of labor market data, beginning with the mainstream launch of ChatGPT in late 2022.
    • “Despite the rapid progress of generative AI, researchers found no clear evidence that the U.S. workforce has undergone widespread displacement. Instead, the occupational mix has remained strikingly stable.
    • “Despite how quickly AI has advanced, the labor market story over the past three years has been one of continuity over change,” said the study’s co-author, Molly Kinder, while speaking to the Financial Times.”
       
  • McKinsey and Co. considers what clinical trials will look like in 2035.
    • “The biopharmaceutical industry stands at a critical juncture, where rapid scientific advancements and increasing competition demand a fresh look at clinical trial delivery. As the industry hurtles toward 2035, the need for a transformative vision has never been more pressing. This article outlines a bold new direction for clinical trials, one that aspires to double trial speed and patient participation while enhancing outcomes and reducing costs. By examining the key drivers of change and the essential elements of a next-generation clinical development engine, we could unlock a future in which clinical trials are more efficient, more accessible, and more patient-centered.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Majority Leader John Thune (R., S.D.) told Senate Republicans Thursday that they should expect to vote on a new proposal Friday aiming to end the government shutdown, according to people familiar with the plan, indicating potential progress in resolving the monthlong impasse. 
    • “The proposal would combine a short-term spending measure with a package of three full-year funding bills, covering the legislative branch, agriculture, and military construction and veterans’ affairs. It was unclear whether the interim measure would keep the government open through mid-December or for a longer period. How Affordable Care Act subsidies, a central concern of Democrats, would figure into the plan also remained in flux. 
    • “The plan to vote on the revised proposal comes as the impact of the shutdown continues to grow. Government workers have gone without pay for weeks, and low-income families are seeing cuts in food aid and other assistance programs. On Thursday, airlines scrambled to review flight plans after federal officials revealed plans to reduce commercial air traffic starting Friday in response to the government shutdown.”
  • It is encouraging to see that the Senate will remain in session this week beyond today.
  • The Journal further reports,
    • “Airlines and travelers scrambled to review flight plans after U.S. transportation officials said they would throttle commercial air traffic starting Friday in response to the government shutdown.
    • “Transportation Secretary Sean Duffy said that traffic at 40 major airports would be reduced by as much as 10% as a safety measure. Air-traffic controllers and airport security agents aren’t being paid in the shutdown, which federal officials said has led to stretched staffing, flight delays and long security lines.
    • “The Federal Aviation Administration will start with a roughly 4% cut in flights this weekend at select airports, according to a Southwest Airlines internal memo reviewed by The Wall Street Journal. Some of the nation’s busiest airports are among those the FAA targeted for flight capacity cuts, including those in Atlanta, Chicago and New York.
    • “To put that in perspective, a 4% reduction in key markets represents approximately 100 flights, a level we routinely manage during standard weather or irregular operational events,” the memo said.”
  • and
    • “A federal judge has ordered the Trump administration to fully fund food-assistance benefits for November by Friday, criticizing the government’s efforts so far to make payments during the government shutdown. 
    • “Judge John McConnell said the administration violated the order he issued last weekthat required the government to tap emergency funds and “expeditiously” pay benefits under the Supplemental Nutrition Assistance Program, or SNAP.” * * *
    • “McConnell chided the government during a hearing on Thursday for its actions. “People have gone without for too long, not making payments to them for even another day is simply unacceptable,” said the judge, an Obama appointee.  
    • “He directed officials to release the full funding to states for November benefits by Friday. SNAP benefits, which cover roughly 42 million Americans, typically total about $8 billion a month. Since the contingency fund wouldn’t cover the full amount, he ordered them to use another source of money to make up the shortfall.” 
  • Tammy Flanagan, writing in Govexec, delves into OPM Director Scott Kupor’s blog entries about modernizing the federal retirement system.
  • Moving onto healthcare, BioPharma Dive relates,
    • “Novo Nordisk and Eli Lilly will sell their GLP-1 drugs for obesity and diabetes to some Medicare enrollees for $245 a month under an agreement hammered out with the Trump administration, the White House announced Thursday.
    • “Through the deal, the two companies will also offer some of the same drugs through an online government portal for about $350 a month. Lilly and Novo will additionally be required to sell starter doses of their coming oral obesity medicines, if approved by regulators, for $149 a month. They’ll have to offer all their weight loss drugs to state Medicaid programs at “most favored nation” prices, too.
    • “The new figures represent discounts to the list prices of Wegovy and Zepbound, which are $1,350 and $1,080 a month, respectively, as well as the $499 monthly charge on Lilly and Novo’s direct-to-consumer sites. But comparisons are different when weighed against the “net” prices that follow negotiations with insurers.” * * *
    • “[T]he Medicare price for GLP-1 drugs will be offered through a pilot program that will cover most beneficiaries, Novo said in a separate press release. That may be necessary, as the law that authorized Medicare coverage of prescription drugs specifically bars weight loss products. But it also likely limits which Medicare beneficiaries will qualify, and could have a fixed expiration date. Those that do benefit will have a $50 monthly copay.
    • “The agreement also won’t apply to the vast majority of people who receive their medications through commercial insurance.”
  • Fierce Pharma adds,
    • “The Trump administration is rolling out a new model that aims to bring most-favored nation pricing to the Medicaid space.
    • ‘The Centers for Medicare & Medicaid Services announced late Thursday the launch of the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) model, under which participating state Medicaid programs will be able to purchase certain drugs at prices that align with what is paid in other countries.
    • “The agency said the model, which launches in 2026, is designed around “allowing Americans to benefit from fairer, more competitive pricing.”
    • ‘CMS said that total gross spending in Medicaid on drugs in 2024 was $100 billion, up by $10 billion from 2022. Through the model, CMS will negotiate with participating pharmaceutical companies to bring down prices, while states that sign on will be able to implement coverage criteria that is uniform and transparent.”
  • The American Hospital Association News informs us,
    • “All 50 states have applied for the Rural Health Transformation Program, the Centers for Medicare & Medicaid Services announced Nov. 5. The program will fund $50 billion to states from fiscal year 2026 to FY 2030. Half of the funds will be awarded as baseline funding, and the other half will be distributed following a data-driven review that will assess each state’s initiatives and their alignment with the program. CMS said it would announce the recipients by Dec. 31.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. This second cohort brings the total number of voucher recipients to 15, underscoring the agency’s commitment to accelerating the review of products with the potential to address key national priorities.” * * *
    • “The following products were selected following external applications and internal nominations from FDA review divisions:
      • Zongertinib for HER2 lung cancer
      • Bedaquiline for drug-resistant tuberculosis in young children
      • Dostarlimab for rectal cancer
      • Casgevy for sickle cell disease
      • Orforglipron for obesity and related health conditions  
      • Wegovy for obesity and related health conditions
  • HCP Live tells us,
    • “The US Food and Drug Administration (FDA) has approved Ironwood Pharmaceuticals’ linaclotide (Linzess) capsules for pediatric patients ≥ 7 years of age with irritable bowel syndrome with constipation (IBS-C), making it the first treatment approved for IBS-C in this patient population.
    • “The drug works by increasing intestinal fluid secretion and reducing pain-sensing nerve activity.
    • “Approval was based on adult data and a pediatric trial showing significant symptom improvement.
    • “Safety profiles were consistent across age groups, with diarrhea as the most common side effect.
    • “Linaclotide is contraindicated in children under 2 due to dehydration risks.”
  • Per BioPharma Dive,
    • “Johnson & Johnson won Food and Drug Administration approval to sell its drug Caplyta for patients suffering from major depressive disorder, a key step in its ambitions to make the medicine a $5 billion-a-year seller.
    • “Caplyta is already cleared to treat patients with schizophrenia and those suffering from bipolar I and II depression, conditions that affect some 13 million Americans combined. Major depressive disorder, also known as clinical depression, afflicts about 22 million Americans and two-thirds of that group don’t get enough relief from current medicines, J&J said Thursday.
    • ‘The latest FDA approval is based on research that showed Caplyta could significantly improve depression symptoms, as well as an open-label study that found that 80% of patients responded to treatment, with 65% achieving remission. At the same time, the drug didn’t cause the side effects such as low sexual desire or weight gain that often leads patients to drop off antidepressant treatments, J&J said.”
  • MedPage Today lets us know,
    • “The FDA sent 18 warning letters to websites that illegally market unapproved and misbranded botulinum toxin (Botox) products, the agency announced.
    • “The letters were addressed to sites with names like cosmo-korea.com, derma-solution.com, glamderma.com, and koreanfillers.com, among several others.” * * *
    • “The sites were reportedly based in South Korea, China, Panama, and the U.S., according to the letters.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Heavy drinking is tied to earlier and more severe brain bleeds, a new study found. The paper, published Wednesday in the journal Neurology, examined the link between alcohol and intracerebral hemorrhages — the deadliest, most disabling type of stroke.
    • “The researchers found that so-called heavy drinkers — people who had three or more drinks per day — developed a stroke on average 11 years earlier than those who had fewer than three drinks per day. They also had larger brain bleeds that were more difficult to manage.
    • “This data cannot prove that alcohol led to earlier, more severe brain bleeds. But it aligns with a wide body of research linking heavy alcohol use to damaged blood vessels and cardiovascular disease.
    • “Alcohol in high doses is toxic to brain cells,” said Dr. Bruce Ovbiagele, a professor of neurology at the University of California, San Francisco, who was not involved with the study.”
  • and
    • “Radiation has long played a role in the treatment of breast cancer, though doctors have used it more sparingly in early-stage disease in recent years, as advances in diagnostics and treatment have improved survival rates.
    • “Now a new study with an unusually long follow-up period has found that radiation to the chest wall made absolutely no difference in survival among women with early-stage breast cancer who had been treated with mastectomy, lymph-node surgery and advanced anti-cancer drugs.
    • “The results of the large, randomized clinical trial were published on Wednesday in The New England Journal of Medicine.”
  • MedPage Today points out,
    • “Observational data point to a relationship between the vascular system and epilepsy beyond the brain.
    • “Among people ages 40 and older, heart attack survivors had a disproportionately greater risk of incident late-onset epilepsy.
    • “Late-onset epilepsy may also be a marker of systemic vascular disease.”
  • Infectious Disease Advisor adds,
    • “Although the second dose of the inactivated influenza vaccine (IIV) significantly increases protection relative to a single dose among children younger than 3 years, this benefit is not observed when the study population is broadened to include children younger than 9 years, according to study findings published in JAMA Network Open.”
  • Per Healio,
    • “A multidisciplinary comprehensive obesity care model increased GLP-1 persistence at 1 year.
    • “Patients in the program also had clinically meaningful weight loss outcomes and lower fat-free mass loss.”
  • Cardiovascular Business notes,
    • “Researchers are working on a new stem cell patch designed to help patients recover after a heart attack. The patch is implanted through a tiny incision, making open-heart surgery unnecessary, and then held in place with a biocompatible adhesive. It then helps the heart recover over time, replacing dead tissue that would typically never be able to regenerate. 
    • “The group behind this new technology presented its latest findings in Acta Biomaterialia.
    • “For patients with severe heart failure, there are very few options beyond mechanical pumps or transplants,” senior author Wugiang Zhu, PhD, a researcher with Mayo Clinic in Arizona, said in a statement. “We hope this approach will offer a new way to repair their own hearts.”
    • “Zhu et al. tested their new patch on rats that were given surgically induced heart attacks. The early findings suggest this approach could provide significant value to heart patients everywhere if it can be fine-tuned and tested on human subjects. Researchers noted that the patch improved heart function and reduced both scarring and inflammation.” * * *
    • “Click here to read the full analysis.” 
  • Beckers Clinical Leadership identifies the 10 hospitals with the lowest number of birth complications and the 10 hospitals with the highest number of those complications.

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “Eighty-eight percent of Americans are content with their health coverage, yet nearly half rate the country’s overall system a “C” or worse, according to a Nov. 6 survey from health insurance marketplace eHealth.
    • ‘The survey collected input from 1,524 adults across the U.S.
    • “This new survey highlights the mixed feelings many Americans have about our health insurance system,” Whitney Stidom, vice president of consumer enablement at eHealth, told Becker’s. “While many people are satisfied with their coverage, out-of-pocket costs are often a burden, and navigating the various coverage options can be challenging for some. It is crucial consumers understand their health insurance options, as doing so can help them save time, potentially reduce costs and encourage access to quality care.”
  • The Wall Street Journal reports,
    • Pfizer PFE is preparing to sweeten its offer again for Metsera, the weight-loss drug startup at the center of a bidding war that also involves Novo Nordisk. 
    • New York-based Pfizer is making plans to deliver a fresh bid Wednesday, according to people familiar with the matter, ahead of a deadline it has to respond to Novo Nordisk’s latest proposal. 
    • Under the terms of its existing merger agreement with Metsera, Pfizer’s next likely step is to match Novo Nordisk’s offer, one of the people said. 
    • Metsera shares closed Wednesday at $71.38 and rose over 7% after-hours after The Wall Street Journal reported on Pfizer’s plans. Novo Nordisk’s offer valued the company at $86.20 a share, while Pfizer’s most recent offer valued it at $70 a share, Metsera said.
  • Per STAT News,
    • “In its latest bid to shake up the prescription drug market, the Mark Cuban Cost Plus Drug Company has reached a deal to sell a cheap, biosimilar version of Stelara, a widely prescribed treatment for chronic inflammatory and autoimmune conditions.
    • “The company plans to sell the lower-cost medication for $345 every three months, or $1,380 a year, for a 90-milligram dose, before shipping costs. This is significantly below the list price for the brand-name drug sold by Johnson & Johnson, which can vary depending on patient weight and the specific illness being treated.”
  • Per BioPharma Dive,
    • “AstraZeneca has exercised an option to acquire SixPeaks Bio, an obesity drug startup that it helped launch last year with Versant Ventures.
    • “AstraZeneca revealed the deal in its latest quarterly earnings report on Wednesday. According to that report, the British drugmaker on Oct. 22 paid $170 million for the shares in SixPeaks it didn’t already own. AstraZeneca will add another $30 million to the deal in two years and could shell out a further $100 million based on the achievement of certain regulatory milestones. 
    • “SixPeaks launched in 2024 with $30 million in funding and a collaboration that gave AstraZeneca the chance to acquire it at an agreed-upon price.” 
  • and
    • “Moderna again reported declining vaccine sales and tempered its 2025 revenue outlook, but expressed confidence in its plan to break even financially in a few years.
    • “In third-quarter earnings on Thursday, Moderna reported $1 billion in revenue, down roughly 45% from the same three-month period a year ago. The company also lowered the top end of its projected revenue forecast for 2025. It now expects between $1.6 and $2 billion, down from an expected range of $1.5 billion to $2.2 billion.
    • “Still, Moderna shares, which have lost more than half of their value over the last year, ticked up as much as 5% in early trading Thursday. One reason why is progress the company has made in cutting costs, with Moderna claiming that, so far, it’s ahead of its projected target for the year. 
    • “We give credit where it’s due, and [Moderna] is clearly making progress on cost control,” Leerink analyst Mani Foroohar wrote in a note to clients Thursday.” 
  • Modern Healthcare reports,
    • “Cambia Health Solutions plans to bring another Blue Cross Blue Shield insurer under its umbrella as it seeks to scale its technology and care management services. 
    • “The nonprofit, which operates Regence Blue Cross plans in Idaho, Oregon, Utah and Washington, announced Thursday that it plans to join forces with Arkansas Blue Cross and Blue Shield. The proposed strategic affiliation is Cambia’s second this year; in August, the company proposed a similar partnership with Blue Cross Blue Shield of North Dakota.
    • “By affiliating, the Blue Cross companies aim to pool their investments and administrative capabilities to develop new technology and care management services, Cambia President and CEO Jared Short said. Partnering could boost each organization’s struggling finances, although that is not the primary driver of the planned affiliations, he said.” 
  • Healthcare Dive informs us,
    • “Dr. Amy Flaster joined Cigna late last year as the CMO of the Connecticut-based company’s health insurance arm. But now, she’s stepping into an expanded role as CMO of the entire business, encompassing both Cigna Healthcare and health services division Evernorth.
    • “Starting Nov. 1, Flaster is leading Cigna’s efforts to improve clinical performance, including testing and introducing new care models, overseeing providers and determining where technology could be an asset.
    • “At Cigna, Flaster will report to COO Brian Evanko.
    • “Her appointment coincides with the departure of Dr. David Brailer, a longtime healthcare executive who served as Cigna’s chief health officer since 2022.” * * *
    • “Cigna also announced that Katya Andresen, Cigna’s chief digital and analytics officer, will oversee the company’s “excellence and transformation” efforts, which shapes customer engagement.”
  • Per MedTech Dive,
    • “Diabetes tech nonprofit Tidepool will collaborate with Ōura to launch a partnership for diabetes research, the companies announced Tuesday.
    • “With users’ consent, Tidepool will pair biometric data from the Oura Ring with data from diabetes devices, including continuous glucose monitors and insulin pumps.
    • “The companies plan to start recruitment in early 2026 through a study approved by an institutional review board. Participants who opt into the study will share their data with Tidepool’s Big Data Donation Project. With users’ consent, the de-identified data will be shared with academics, researchers and industry to accelerate diabetes research.”

From the artificial intelligence front,

  • Beckers Health IT reports,
    • “Rochester, Minn.-based Mayo Clinic has introduced a program to help other health systems adopt AI.
    • ‘Mayo Clinic Platform_Insights provides a “guided, affordable path” for healthcare organizations of all sizes to keep up with advances in the technology, the health system said.
    • “Digital solutions and artificial intelligence have enormous potential to transform healthcare but there are barriers to widespread adoption,” stated Maneesh Goyal, COO of Mayo Clinic Platform, the health system’s digital innovation arm, in a Nov. 3 news release. “When organizations partner with us, they gain access to proven clinical and administrative solutions and the technical framework to integrate them seamlessly.”

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Politico reports,
    • “Republicans say they are close to finalizing a package of full-year funding measures for select federal agencies — a critical piece of bipartisan negotiations over the terms for ending the prolonged government shutdown.
    • “The mini-package should be nearing completion, and that will be the vehicle” for the stopgap spending bill to reopen the government, Senate Majority Leader John Thune said Wednesday after a closed-door GOP lunch.
    • “Thune met Tuesday night with Democratic negotiators on the shutdown, including Sen. Jeanne Shaheen of New Hampshire and Sen. Angus King (I-Maine), who caucuses with Democrats. Bipartisan negotiators want the Senate to stay in session through the weekend to finish a deal, according to two people granted anonymity to disclose private dynamics. 
    • “While Thune didn’t rule out staying past the Senate’s normal Thursday afternoon exit time, he said he’d need to first see how much progress was being made.”
  • The Wall Street Journal reports,
    • “The Federal Aviation Administration said it was ordering airline traffic to be reduced by 10% at 40 airports while air-traffic controllers work without pay during the government shutdown.
    • “Transportation Secretary Sean Duffy said starting Friday, the reduction would help keep air travel safe as flight delays and cancellations pile up. The shutdown, which began Oct. 1, has exacerbated staffing issues in the ranks of federal transportation employees, leading to flight delays and long lines at security checkpoints. 
    • “This is about where’s the pressure and how do we alleviate the pressure,” Duffy said Wednesday at a news briefing.”
  • Per an OPM news release,
    • “The U.S. Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) today released new guidance to federal agencies on how to implement President Donald Trump’s Executive Order 14356, Ensuring Continued Accountability in Federal Hiring. In his first year in office, President Trump met and exceeded the ratio of four employee departures for each new hire, this guidance directs agencies on how to ensure federal hiring remains cost-effective, mission-focused, and aligned with administration priorities.
    • “This is about ensuring government works better for the American people,” OPM Director Scott Kupor said. “We’re bringing accountability and discipline to every hiring decision, making sure agencies are staffing for mission need, not bureaucratic habit.” * * *
    • “Read the memo here and Director Kupor’s blog on this here.”
  • Federal News Network points out,
    • “As Open Season approaches, one Republican is raising concerns about funding for the Federal Employees Health Benefits program. Sen. James Lankford (R-Okla.) is questioning the Office of Personnel Management on how it plans to avoid exhausting the FEHB’s trust fund. He said it’s a concern, since there aren’t any incoming contributions to the trust fund under the government shutdown. In response to Lankford’s questions, OPM said that if needed, it would be able to let health carriers request additional funding from contingency reserves. But for the time being, OPM said all FEHB plans have sufficient funds to pay claims.(Letter to OPM on FEHB program under shutdown – Sen. James Lankford (R-Okla.))”
  • and
    • “The Office of Personnel Management is hinting at some upcoming tech hiring initiatives. The specific timeline for launching the OPM initiatives is unclear, and many details of the tech hiring efforts are still in the works. But agencies should be focused on tech recruitment, particularly in artificial intelligence, according to OPM Director Scott Kupor. “I think the thing that government has to do is not be the last dinosaur. If we do that, there’s no amount of organizational structure or marketing or anything else that’s going to save us, we have to be willing to embrace these things,” Kupor said at a NAPA conference on Monday. (OPM’s Kupor wants more tech expertise in the federal workforce – Federal News Network)”

From the judicial front,

  • Per Fierce Biotech,
    • “Amid the rapidly unfolding saga revolving around Metsera, a judge has denied Pfizer’s request to block Novo Nordisk’s buyout bid for the biotech, Bloomberg reports.
    • Delaware Chancery Judge Morgan Zurn has refused to deliver a Pfizer-requested temporary restraining order, saying the pharma’s objections to the proposed deal weren’t a legitimate reason for stopping Novo’s offer, according to the publication.” * * *
    • “Meanwhile, Pfizer has said it remains “confident” in the merits of its claims and its belief that Metsera is breaching its contractual obligations.
    • “Today’s decision does not address the merits of the underlying legal issues raised, and Pfizer intends to continue to pursue its claims vigorously through the ongoing litigation process as well as in its parallel antitrust litigation pending in Delaware federal court,” the pharma said in a Nov. 5 statement in response to the ruling.”
  • STAT News reports,
    • “The Federal Trade Commission has raised concerns about Novo Nordisk’s attempt to outbid Pfizer to acquire obesity startup Metsera, the latest complication in a dramatic bidding war between two pharma giants.
    • “Companies normally have to seek FTC review for acquisitions under a law called the Hart-Scott-Rodino Premerger (HSR) Notification Act. The companies must wait a prescribed amount of time after the filings are submitted before concluding their transaction.
    • “Novo’s deal is structured so that it would first pay a large amount to acquire half of Metsera’s stock. If Novo does that before seeking regulators’ review, then it may violate the act, Daniel Guarnera, director of the bureau of competition at the FTC, wrote in a letter sent Tuesday to lawyers of Novo and Metsera.”

From the public health and medical / Rx research front,

  • The American Hospital Association News tells us,
    • “There have been 1,681 confirmed cases of measles in the U.S. so far this year, according to the latest Centers for Disease Control and Prevention data. Cases have been reported by 42 states and jurisdictions, and 12% of cases have been hospitalized. There have been 44 reported outbreaks, and 87% of all cases are outbreak-associated. The vaccination status of 92% of all confirmed cases is classified as “unvaccinated or unknown.” 
  • and
    • “An AHA blog examines how the Cleveland Clinic’s food-as-medicine strategy reaches far beyond clinical care by using a multi-angle approach to food access and nutrition. READ MORE” 
  • Health Day informs us,
    • “Tobacco remains the leading preventable cause of cancer death in the U.S., despite a dramatic decline in smoking, a new American Cancer Society report says.
    • “More than 80% of lung cancer deaths are linked to tobacco, according to data from the inaugural release of the American Heart Association’s U.S. Tobacco Atlas.
    • “That’s even though cigarette smoking among adults cratered from 42% in 1965 to just 11% in 2023, researchers said.
    • “Quit rates also have skyrocketed, with a record 62% of smokers trying to drop the habit in 2022, the reports say.
    • “However, smokers are shunning the low-dose CT chest scans that are recommended for lung cancer screening, results show.
    • “Only 18% of eligible current or former smokers were up to date with screening in 2022 — such screening can catch cancers early and improve survival odds.”
  • MedPage Today adds,
    • “Though the percentage of U.S. teenagers who vape nicotine has declined in recent years, daily vaping among those already doing so increased, as did unsuccessful quit attempts, a cross-sectional study suggested.
    • “In a pooled sample of more than 115,000 respondents from the Monitoring the Futureopens in a new tab or window survey, prevalence of past-30-day nicotine vaping declined from 17.8% in 2020 to 10.1% in 2024 (RR 0.88, 95% CI 0.86-0.89), reported Abbey Masonbrink, MD, MPH, of the Keck School of Medicine at the University of Southern California in Los Angeles, and colleagues.
    • “However, among more than 15,000 respondents who currently vape, prevalence of daily vaping increased from 15.4% in 2020 to 28.8% in 2024 (RR 1.14, 95%CI 1.11-1.18), they reported in JAMA Network Openopens in a new tab or window. And among more than 3,500 daily vapers, prevalence of unsuccessful quit attempts rose from 28.2% in 2020 to 53% in 2024 (RR 1.08, 95%CI 1.02-1.15).
    • “Despite recent trends in decreasing overall prevalence of nicotine vaping in youth, our research team was concerned about the potential for increasing hardening among current youth users,” Masonbrink told MedPage Today in an email. “As recently evolving nicotine vaping products allow for higher nicotine exposure and known treatment barriers for youth, we wanted to assess for increasing frequency of use and nicotine dependence in this population.”
    • “Ultimately, the study found a “concerning recent trend of increasing trends in daily use among youth who are current users by nearly double and increasing inability to successfully quit, a marker of nicotine dependence, in this population,” she said.”
  • The Wall Street Journal offers advice from Team USA’s doctor on how to avoid becoming ill during air travel.
  • The Washington Post discusses prospects for an experimental pancreatic cancer treatment pill.
    • “Based on early clinical trial results, the Food and Drug Administration in October awarded the drug’s sponsor, biotech company Revolution Medicines, a new and unconventional accelerated review designed to get promising drugs to patients faster than ever. The pancreatic cancer drug, and other medications selected under the “Commissioner’s National Priority Voucher” initiative, will test whether it can expedite novel treatments without compromising the rigor of agency reviews, experts say.” * * *
    • “The FDA’s selection of Revolution Medicines’ daraxonrasib appeared to cement its status as one of the most promising experimental cancer drugs. It also is being studied for treating lung and colorectal cancer.
    • One of the company’s first clinical trials gave daraxonrasib to 83 patients whose pancreatic cancer had spread after undergoing at least one earlier intervention, such as chemotherapy. Over more than 16 months, at least 29 percent of the participants saw their tumors shrink while more than 90 percent saw no tumor growth. The median overall survival was 15.6 months, according to the results, which by some measures is about twice as long as such patients typically fare with standard treatments. Results of its first major, randomized trial, with about 460 patients, are expected next year.”
  • Medscape adds,
    • “A blood-based biomarker test, PancreaSure, demonstrated high sensitivity and specificity in differentiating patients with early-stage pancreatic ductal adenocarcinoma (PDAC) from control individuals at high risk. The test outperformed CA19-9 alone, showing higher sensitivity across two independent clinical validation studies.”
  • Cancer Therapy Advisor notes,
    • “Beginning statin therapy within 36 months of breast cancer diagnosis is linked to improved survival for patients with early-stage disease, compared to patients who do not use statins, according to research published in JAMA Network Open.
    • “These findings highlight the potential of statins as an adjunctive therapy in [breast cancer] treatment, offering a promising avenue for enhancing clinical outcomes,” study researchers wrote.”
  • Per MedPage Today,
    • “Moderate to severe obstructive sleep apnea (OSA) independently correlated with development of cerebral microbleeds seen on brain MRI.
    • “Cerebral microbleeds are considered an early marker of cerebral vasculopathy and are associated with increased risk of developing symptomatic stroke and dementia.
    • “Moderate to severe OSA should be a potential target for early diagnosis and treatment to potentially prevent future strokes and dementia in aging populations, although the study did not assess those outcomes.”
  • and
    • “Survival rates of people with young-onset dementia — dementia diagnosed before age 65 — varied considerably by clinical type, a population-based cohort study in Finland showed.
    • “The median survival for young-onset dementia (also known as early-onset dementia) was 8.7 years, said Eino Solje, MD, PhD, of the University of Eastern Finland in Kuopio, and co-authors.
    • “The shortest survival was seen in people with young-onset frontotemporal dementia (6.9 years) or alpha-synucleinopathy (7.0 years). The longest survival was seen in people with young-onset Alzheimer’s disease (9.9 years) and those with mixed or other dementias (more than 10 years).”
  • Beckers Hospital Review identifies “14 recent drug shortages and discontinuations, according to FDA drug supply databases.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana is convinced that it can grow both the size and profitability of its Medicare Advantage business in 2026, despite concerns that the insurer’s plans are too generous and could saddle the company with undesired costs.
    • ‘Executives said they’re confident in their plan pricing and design on a call to discuss Humana’s third quarter results Wednesday morning — though, they noted there are steps Humana can take to manage membership growth if it starts looking like it may get out of hand as open enrollment continues.
    • “Humana said it’s still on track to double pre-tax margins in the privatized Medicare plans next year compared to 2025. But that forecast excludes the impact of quality or “star” ratings. The number of Humana members in highly rated plans dropped for 2026, complicating its path to profit recovery during a difficult time for payers in government programs.”
  • and
    • “Amwell is considering divesting some non-core assets as the telehealth vendor looks to narrow its business focus and improve financial performance, executives said on a third quarter earnings call Tuesday. 
    • “The company is mulling selling legacy assets that could be more easily separated from the rest of the business without creating challenges for customers, executives said. “These are distinct assets that have a certain profile of clients that we could, in fact, cordon off,” said Amwell CFO and COO Mark Hirschhorn.
    • “Amwell already sold its virtual psychiatric care business to fellow telehealth provider Avel eCare for about $21 million early this year.” 
  • and
    • “The fate of bankrupt Prospect Medical Holdings’ two Rhode Island hospitals hangs in a precarious balance this week, as the health system and the state’s attorney general clash in court over Prospect’s desire to close the facilities by year end. 
    • “Prospect sought court approval to close the two safety-net hospitals on Thursday, saying in court documents that the facilities are losing millions each month and that sale conditions imposed by state regulators make a deal untenable.
    • “The Centurion Foundation, the hospitals’ proposed buyer, and attorney general Peter Neronha opposed the motion in their own filings on Monday. Neronha warned closures would be “catastrophic” for patients.”
  • Fierce Healthcare relates,
    • “Hinge Health wrapped up another strong quarter—its second as a public company—as its results beat Wall Street expectations and the company boosted its 2025 outlook.
    • “The virtual physical therapy company, which went public in late May, brought in third-quarter revenue of $154 million, up 53% from the same period a year ago. Wall Street analysts expected revenue of $142 million.
    • “Hinge’s third-quarter revenue performance exceeded the high end of its guidance range of $141 million to $143 million “due to strong billings performance stemming from the continued strength of the company’s underlying fundamentals,” the company’s chief financial officer James Budge told investors and analysts on the company’s third-quarter earnings call Tuesday.”
  • and
    • “Medicare Advantage (MA)-focused insurtech Clover Health saw its revenue climb by 50% year over year in the third quarter, per its earnings report released late Tuesday.
    • “Clover reported $496.6 million in total revenue for the quarter, up from $331 million in the third quarter of 2024. Through the first nine months of the year, revenues were $1.4 billion, compared to the company’s haul of $1 billion through the first three quarters of 2024.
    • “The company also posted a $24.4 million net loss in the quarter, with its losses increasing from $9.2 million in the prior-year quarter. Clover has reported $36.2 million in losses through the first three quarters of the year, up from $20.9 million in losses a year ago.
    • “The company reported $2 million in earnings before interest, taxes, depreciation and amortization.
    • “Our model of care continues to perform well as we bring our technology-powered care to more Medicare Advantage seniors,” said Clover Health CEO Andrew Toy in the earnings release.”
  • and
    • “Carrum Health launched a substance use disorder treatment program for employers a year ago and has now expanded it to include cannabis, cocaine and methamphetamine as employer demand surges.
    • “It’s estimated that 29 million U.S. employees—1 in 6 working adults—are struggling with substance use disorder. Approximately 6.5% of full-time U.S. employees met the criteria for a cannabis use disorder in a 2021-22 study. Another study found that workplace cannabis consumption was highest among workers in states with “recreational” cannabis laws.
    • “This poses a major health challenge for employers, and there’s a critical unmet need for cost-effective prevention and treatment strategies.”
  • The American Journal of Managed Care tells us,
    • “Adequate outpatient follow-up within 30 days significantly reduces 30-day all-cause hospital readmissions, impacting hospital finances and patient care quality.
    • “The study analyzed 83 studies, primarily US-based, showing reduced readmission risks for heart failure and acute myocardial infarction with timely follow-up.
    • “Heterogeneity in study designs and US-centric data limit the generalizability of findings to other health systems.
    • “Authors emphasize considering patient-specific risk factors in prioritizing post-discharge follow-up to optimize outcomes.”
  • Per BioPharma Dive,
    • Novo Nordisk reined in expectations for full-year sales and profit amid expected price cuts and a disappointing third quarter for its obesity drug Wegovy.
    • The Danish drugmaker now expects sales growth of 8% to 11% for the year after previously predicting revenue might expand by as much as 14%. Operating profit will likely grow between 4% and 7%, down from an estimate of as much as 10%, Novo said Wednesday, a shift executives attributed on a conference call to “intensifying competition and pricing pressure.”
    • Sales of semaglutide, sold as Wegovy for obesity and Ozempic for diabetes, continued to rise in the third quarter and together brought in more than 51 billion Danish kroner, or about $7.9 billion. But analysts had been looking for more from Wegovy, and the combined total fell short of Eli Lilly’s rival Zepbound/Mounjaro drug, which became the world’s best-selling medicine in the third quarter with more than $10 billion in revenue.
  • Per Fierce Pharma,
    • “Madrigal’s Rezdiffra generated sales of $287 million in the third quarter for a 35% sequential jump from Q2. In just its fifth full quarter on the market, the world’s first treatment for metabolic dysfunction-associated steatohepatitis (MASH) is now annualizing at more than $1 billion.
    • “While the numbers are heady and a second MASH treatment has recently entered the market, Madrigal says there is significant room for growth. Because the disorder is underdiagnosed, the company figures that competition from Novo Nordisk’s GLP-1 Wegovy—which gained an FDA label expansion to treat MASH three months ago—will help increase the patient pool.
    • “We welcome new entrants to this evolving market. Wegovy’s recent approval in MASH adds momentum to a market that’s just starting to take shape,” Madrigal CEO Bill Sibold said on a quarterly conference call. “Novo is targeting a much larger population, which will raise awareness and drive more screening, diagnosis and treatment.”

Tuesday Report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senators said they were increasingly optimistic that they could reach a bipartisan deal to end the government shutdown, while President Trump raised pressure on Republicans to bypass Democrats and end the near-record-setting impasse without their votes.
    • “Senate Majority Leader John Thune (R., S.D.) on Tuesday outlined a pathway forward, pointing to the possibility of combining a new short-term bill to reopen the government with some of the 12 annual appropriations bills that fund federal agencies. He said that the off-ramp was focused on giving Democrats a vote on an extension of expiring Affordable Care Act subsidies along with plans for the spending bills.
    • “I’ve said this before, but the question is whether or not they’ll take ‘yes’ for the answer,” Thune said.
    • “Several lawmakers said they thought the shutdown would come to a close by the end of the weekend if talks progressed.
    • “I think we’ve got a real shot,” Sen. John Hoeven (R., N.D.) said of the possibility of the shutdown ending soon.
    • “We’re continuing to talk.” said Sen. Gary Peters (D., Mich.). “We’re in a sensitive time right now.”
  • The Hill adds,
    • “A quartet of bipartisan House lawmakers on Monday proposed a framework to temporarily extend ObamaCare’s enhanced tax credits that includes a sunset period and an income cap for high earners. 
    • “The “statement of principles” from centrist Reps. Don Bacon (R-Neb.), Tom Suozzi (D-N.Y.), Jeff Hurd (R-Colo.) and Josh Gottheimer (D-N.J.) represents the only public proposal from either side to address the subsidies since the government shut down more than a month ago.” 
  • MedTech Dive tells us,
    • “The co-chairs of the House and Senate Diabetes Caucuses urged the Centers for Medicare and Medicaid Services not to finalize proposed changes that would affect how the agency pays for diabetes devices.
    • “In June, the CMS issued a proposed rule to include insulin pumps and continuous glucose monitors in a competitive bidding program. It would also change payments to a monthly rental rather than a contract where devices are paid for upfront. 
    • ‘In a letter sent to CMS Administrator Mehmet Oz in October, caucus leaders raised concerns that the changes would reduce and complicate access to CGMs and insulin pumps. Medtech lobbying group AdvaMed issued a statement on Monday also urging the CMS not to finalize the proposal.”
  • HealthLeaders Media informs us,
    • “The final 2026 CMS Physician Fee Schedule eliminates frequency limits on telehealth services inside hospitals and skilled nursing facilities and allows for remote supervision and training.
    • “However, CMS is eliminating a five-year-old policy that allowed providers to report and bill for remote services using their practice location, a move that could prompt doctors to avoid treating patients during nights and weekends.”
  • Kevin Moss, writing in Govexec, offers Open Season advice to federal and postal employees and annuitants.
  • Federal News Network interviews Thiago Glieger from RMG Advisors about OPM’s new retirement claims process system known as ORA.
  • The Wall Street Journal relates,
    • “The Trump administration is negotiating a deal with weight-loss drugmakers Eli Lilly LLY and Novo Nordisk NOVO.B that would allow the lowest doses of some of their obesity drugs to be sold to consumers at $149 for a month’s supply via TrumpRx, according to people familiar with the matter.
    • “The deals would also result in Medicare and Medicaid covering the drugs for weight loss, the people said, which would be a boon to the companies.
    • “The discussions are still ongoing but if agreements are finalized, Trump is expected to announce them Thursday morning at the White House, alongside pharmaceutical executives, the people said.”
  • This development would unlock tremendous savings for FEHB and PSHB plans which now must pay primary for these drugs when prescribed for obesity to Medicare prime annuitants. Following implementation, the FEHB and PSHB plans would pay secondary to Medicare for those folks.

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled lot of 20 mEq potassium chloride injection bags. The notice said the products are incorrectly labeled with a 10 mEq overwrap. The company said a potential overdose of potassium chloride is possible if an incorrect dosage is used, potentially leading to hyperkalemia. Otsuka ICU Medical said it has not yet received any reports of adverse events due to the issue.”
  • Per Fierce Pharma,
    • “UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian company.
    • “The U.S. nod for Kygevvi—which is the third rare disease drug approval for the company in less than three years—is to treat the genetic mitochondrial disease thymidine kinase 2 deficiency (TK2d). It is the first targeted medicine for the muscle-weakening disorder. Kygevvi is cleared for adults and pediatric patients who have experienced symptom onset by age 12.
    • “When TK2d appears early in life, it increases the risk of rapid progression and death. It can be fatal within three years of symptoms emerging. TK2d strikes an estimated 1.64 in every 1 million people, affecting patients’ ability to walk, eat and breathe independently.”
  • Per MedTech Dive,
    • “Dexcom recalled an Android app for its G6 glucose sensor due to a software problem that could cause the app to terminate unexpectedly.
    • “The issue could cause users to miss alarms, alerts or notifications related to estimated glucose values, according to a Food and Drug Administration database entry posted Oct. 30.
    • “The glucose sensor and the app are still available, but Dexcom required users to update the app to a new version. 
    • “Dexcom began the recall on Aug. 28. The FDA designated the event as a Class 1 recall, the most serious kind.” 
  • The Washington Post reports,
    • “At least six people across the United States have become ill and died after eating prepared pasta meals linked to a growing listeria outbreak, federal health officials said.
    • “Fettuccine, linguine, farfalle and other pasta meals sold at major grocery stores including Albertsons, Kroger, Sprouts Farmers Market and Trader Joe’s have been recalled over the past few months.
    • “Supplier Nate’s Fine Foods expanded its recall in September after a pasta sample tested positive for Listeria monocytogenes, the Food and Drug Administration said. The company said it was working with health officials to investigate the source.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics intends to seek full U.S. clearance for a pair of Duchenne muscular dystrophy medicines even though the two treatments failed a study designed to confirm the benefits observed in earlier testing. 
    • “According to Sarepta, after 96 weeks of treatment, patients receiving the drugs, Vyondys 53 and Amondys 45, instead of a placebo didn’t achieve statistically significant benefits on the study’s main objective, a measure of how quickly they can climb four steps. Sarepta, however, said Monday that the nine-year study, called Essence, was compromised by the COVID-19 pandemic and that the medicines demonstrated “consistent clinically favorable trends.” 
    • “On a conference call with analysts, Sarepta CEO Doug Ingram said the company intends to meet with the agency to discuss converting the accelerated approvals for Vyondys 53 and Amondys 45 into traditional clearances. Despite the study’s failure, “we believe we have a good argument,” he said, noting the “totality of the evidence” generated to date, which includes years of testing and real-world use.”

From the public health and medical / Rx research front,

  • Beckers Hospital Review explains “why delayed care is taking on new urgency for health systems.”
    • “While delayed care remains a top concern for hospital leaders, their strategies also reflect broader shifts toward prevention and long-term health outcomes.
    • “Mr. Robinson was promoted to president of Arkansas Heart Hospital in October after serving as the hospital’s chief strategy and operations officer. He said one of his priorities is a more expansive focus on health outcomes, rather than internal operations.
    • “It’s a mindset shift. It’s the age-old adage: healthcare versus sick care. We do a really good job of offering sick care, but we call it healthcare. I think there are some incredible things we do in sick care,” he said. “But there’s great value in offering true healthcare, which is more prevention- and education-based.”
    • “He specifically pointed to AHH’s intensive cardiac rehab program, which is designed to help prevent a second cardiac event through supervised exercise, nutrition education and lifestyle coaching. The overall goal of the program is to improve long-term outcomes.
    • “In my mind, that’s excellent care,” Mr. Robinson said. “But what if, instead of just rehabilitation, we had ‘prehabilitation’ — going into communities with supervised exercise, nutrition, education and coaching to prevent the first cardiac event?
    • “That’s where my mind goes with this role change [to president]: How do we partner with communities, rural hospitals and local clinics? How do we increase education, screening and opportunities to prevent cardiovascular disease before it starts?”
  • Beckers Clinical Leadership points out,
    • “A surgical team at New York City-based NYU Langone Health has performed the first pig-to-human kidney transplant as part of a new clinical trial for patients with end-stage renal disease.
    • “The multisite Expand study is the first U.S. clinical trial to evaluate the safety and efficacy of a genetically engineered pig kidney. The organ, developed by United Therapeutics Corp., features 10 gene edits — six human genes added to improve immune compatibility, and four porcine genes inactivated to reduce rejection risk and control growth.
    • “Participants will be monitored for 24 weeks after transplant, with lifetime follow-up to assess kidney function and screen for zoonotic infections.
    • ‘While other pig kidney transplants have been performed in the U.S. under the FDA’s Expanded Access pathway, the Expand study is the first to proceed under a formal clinical trial framework intended to support regulatory approval. One such Expanded Access program is underway at Mass General Brigham in Somerville, Mass., using organs developed by eGenesis.”
  • Healio adds,
    • “National implementation of a race-neutral eGFR equation contributed to more modifications and higher kidney transplantation rates for Black candidates, according to study data published in the Journal of the American Society of Nephrology.
    • “Before 2023, a race-inclusive equation was used in determining kidney transplant prioritization. According to Jesse D. Schold, PhD, MStat, MEd, professor of surgery and associate vice chair of policy and outcome at the University of Colorado Anschutz Medical Campus, this equation perpetuated disparities in wait times, notably for Black candidates.”
  • MedPage Today notes,
    • “After an increase in colorectal cancer among patients younger than 50, U.S. guidelines started recommending that screening begin at age 45 for average-risk adults.
    • “This study showed that facility-based colorectal cancer screening rates among adults ages 45 to 49 increased about 10-fold following guideline changes.
    • ‘Among over 7 million screenings, the proportion involving individuals ages 45 to 49 increased from 2.9% in the period before the guideline changes to 17.8% after the changes.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “By stimulating cancer cells to produce and release an enzyme that activates the cGAS-STING signaling pathway in nearby immune cells, MIT researchers found a way to force tumors to trigger their own destruction.
    • “The researchers used lipid nanoparticles (LNPs) to deliver cyclic GMP-AMP (cGAMP) synthase (cGAS) mRNA to cancer cells. This results in production of the endogenous stimulator of interferon genes (STING) agonist cGAMP, which is then released and transferred to neighboring immune cells. STING is a protein that helps to trigger immune responses.” * * *
    • “[MIT researcher Natalie] Artzi [Ph.D.] is senior author of the team’s published paper in Proceedings of the National Academy of Sciences(PNAS), titled “Restoration of cGAS in cancer cells promotes antitumor immunity via transfer of cancer cell–generated cGAMP,” in which they concluded “These findings highlight how cancer cells can be used to actively contribute to their own elimination and may be a broadly applicable strategy for delivery of other reprogramming molecules to cancer cells and wider therapeutic combinations.” Alexander Cryer, PhD, a visiting scholar at IMES, is the study’s first author.”
  • Per Neurology Advisor,
    • “Combination therapies that integrate pharmacologic and nonpharmacologic interventions produce the greatest improvements in cognition, behavior, and daily functioning among adults with Alzheimer disease, outperforming either approach alone.”
  • Surprisingly, at least to the FEHBlog, Health Day tells us,
    • “Women are gritting out menopause without seeking any treatment for their symptoms, a new Mayo Clinic study says.
    • “More than 4 out of 5 women said they did not seek medical care for menopause symptoms, researchers reported in Mayo Clinic Proceedings.
    • “Menopause is universal for women at midlife, the symptoms are common and disruptive, and yet, few women are receiving care that could help them,” said lead researcher Dr. Ekta Kapoor, an endocrinologist and menopause specialist at the Mayo Clinic in Rochester, Minnesota.
    • “This gap has real consequences for women’s health and quality of life, and it’s time we address it more proactively,” Kapoor said in a news release.”

From the U.S. healthcare business front,

  • Fierce Pharma discusses Pfizer’s November 4 earnings announcement, while BioPharma Dive delves into Vertex’s latest earnings announcement.
  • CNBC reports,
    • “The blockbuster weight loss drug market is entering a new chapter of growth.
    • “Eli Lilly and Novo Nordisk are both focused on fighting for market share, ramping up supply, testing new uses for their medicines and bringing the next wave of obesity drugs to patients.
    • “Trailing behind them is a slate of drugmakers racing to win a slice of what some analysts expect could be a roughly $100 billion market by the end of the decade.
    • “But questions remain about insurance coverage, drug pricing, copycat treatments and the role of pills.”
  • The Wall Street Journal adds,
    • “Drugmakers Novo Nordisk NOVO.B and Pfizer PFE raised their offers in the multibillion-dollar takeover battle for obesity-drug developer Metsera MTSR, the latest twist in their unusual fight over the startup.
    • “Metsera said Tuesday that Novo Nordisk’s proposal values the biotech company at up to $86.20 a share, or approximately $10 billion, up from its previous bid of $9 billion. This valuation represents an approximately 159% premium to Metsera’s closing price on Sept. 19, the last trading day before the Pfizer deal was disclosed.
    • “Pfizer’s new offer values Metsera at up to $70 a share, or about $8.1 billion. Pfizer had previously struck a deal to buy Metsera for up to $7.3 billion.
    • “It is rare for companies to reopen bidding after a deal has been reached. The duel between two of the world’s biggest drugmakers over a 3-year-old company with just over 100 employees and no approved drugs shows the importance of weight-loss drugs to the pharmaceutical industry.” * * *
    • “The Danish company’s effort to snatch away Metsera has touched off a legal battle with Pfizer. On Friday, Pfizer sued Metsera in Delaware Chancery Court, seeking to block the startup from terminating its September merger agreement with Pfizer.
    • Metsera said Pfizer was improperly asking the court to intervene in what should be a standard bidding process. 
    • “The Court should refuse Pfizer’s attempt to wipe out Novo’s superior topping bid, especially in a live auction where further increased bids may come from Pfizer itself if this Court rejects its proposed” restraining order, Metsera wrote in a document filed Monday in Delaware Chancery Court.
    • “Pfizer filed a second lawsuit on Monday against Metsera and Novo Nordisk in federal court, alleging the weight-loss drug developers’ recent merger agreement would violate federal antitrust laws.” 
  • Fierce Healthcare reports,
    • “Hims & Hers stock jumped 6% in post-market trading Monday after the company said it was in active discussions to make Wegovy injections and Novo Nordisk’s forthcoming obesity pill available through the company’s online platform.
    • “Novo Nordisk expects to launch an oral obesity drug in the U.S. next year, once the Food and Drug Administration approves it.
    • “Hims & Hers said in a statement in its third-quarter financial results that “discussions are ongoing, no definitive agreement has been executed with Novo Nordisk, and there is a possibility that no definitive agreement may ever be executed with Novo Nordisk.”
  • STAT News adds,
    • “Noom, Found, and Hims & Hers have all launched programs to prescribe “microdosed” GLP-1s in the last three months, following in the footsteps of many smaller direct-to-consumer telehealth companies. Microdosing is getting a shot of promotion from Hollywood, too: Noom has promoted its program alongside a new celebrity spokesperson, actor Rebel Wilson, and TV host Andy Cohen has been doing the rounds talking about his microdosing habit. 
    • “In their marketing, telehealth companies claim that compounded GLP-1s in small doses — starting lower than FDA-approved doses from Novo Nordisk and Eli Lilly — can reduce metabolic risk, lower inflammatory markers, and even lower the risk of cognitive decline.
    • “Physicians and researchers say there is no robust clinical evidence that semaglutide or tirzepatide are effective at very small doses, and the drugs aren’t proven to help patients with many marketed symptoms. “Essentially these patients are guinea pigs, both on the efficacy side and the safety side,” said Reshma Ramachandran, a health services researcher and clinician at the Yale School of Medicine.”
  • and
    • “A spinout from the lab of Nobel laureate Jennifer Doudna has raised $82 million to create drugs that, with a single infusion, can turn patients’ immune cells into cancer- and autoimmune disease-fighting drones.
    • “It’s the latest entrant in a high-stakes race to develop what’s known scientifically as in vivo CAR-T treatments. Today’s CAR-T therapies are highly effective at treating certain blood cancers, but patients’ cells have to be removed, reengineered in a facility, and then reinfused — a toxic, expensive, and cumbersome process. Investors and pharma companies are spending billions to create alternatives that transform patients’ cells in their body.
    • “The company, known as Azalea Therapeutics, quietly raised a $17 million seed round in 2023 and then closed $65 million in new Series A last week. It’s a notable raise amid a protracted downturn for gene-editing startups. The last startup to emerge from Doudna’s lab, where CRISPR was first pioneered, was Scribe Therapeutics in 2020. Scribe last raised money from venture capitalists in 2021 and was forced to cut costs and lay off 20% of its staff at the start of this year.”


       

Thursday report

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

From Washington, DC,

  • The Hill reports,
    • “Senate Republicans and Democrats are trying to hammer out a proposal to end the 30-day government shutdown as soon as next week, as some centrist Democrats argue behind the scenes that their party has successfully highlighted rising health care costs and it’s time to end the stalemate.
    • “Shutdown fatigue on Capitol Hill is growing as the government stoppage approaches the one-month mark, and the pain is increasing.” * * *
    • “My assessment is that we’ve won anything that we can possibly win and the costs of continuing the shutdown are going to be felt by people who are going to food banks and federal employees,” said one Democratic senator, who requested anonymity to argue that any political benefit of extending the shutdown is about to be outweighed by the harms inflicted on ordinary Americans.”
  • Federal News Network adds,
    • “The White House is tapping into three Defense Department’s accounts to pay troops this week as the government shutdown stretches on.” * * *
    • “Elaine McCusker, a senior fellow at the American Enterprise Institute and former Pentagon comptroller, said the $5.3 billion the White House identified this time, combined with roughly $1.5 billion left from the $8 billion transferred earlier this month, could be just enough to keep this round of paychecks flowing. And if there’s a gap, she said, the government could temporarily delay some payroll-related costs to make the numbers work.
    • “If it is short, they may be able to defer payment of some military pay expenses that come at the end of the month, not in the middle of the month, like retirement accrual and Social Security tax until the shutdown ends. If they say the cost was $6.5 billion in the middle of month, and they have $6.8 with those various sources available for tomorrow, it could be pretty close. And if they have a little bit of a gap, they might be able to temporarily defer some of those other payroll-type costs until they can replenish the fund,” McCusker told Federal News Network.
    • “The Defense Department also received a $130 million donation from billionaire Timothy Mellon to fund military salaries.:
  • Modern Healthcare tells us,
    • “If Express Scripts and other pharmacy benefit managers thought they could circumvent stricter laws governing their business practices by making changes on their own, these lawmakers want them to know the strategy isn’t working.
    • “Leading supporters of PBM legislation such as Sen. Chuck Grassley (R-Iowa) and Rep. Buddy Carter (R-Ga.) reacted positively to Cigna’s announcement that its Express Scripts subsidiary would phase out drug rebates and phase in upfront discounts for commercial health plans. They also said their bills remain necessary, and that they expect passage after years of letdowns.”
  • MedTech Dive informs us,
    • “The United States and China reached a consensus agreement related to tariffs and other trade-related priorities during a Thursday morning meeting in South Korea between the countries’ leaders and other officials.  
    • “As part of the arrangement, the U.S. will lower tariffs related to fentanyl trafficking on imports from China to 10%, down from 20%, effective immediately, U.S. President Donald Trump told reporters Thursday on Air Force One. A spokesperson for China’s Ministry of Commerce confirmed the reduction and also said the U.S. would further extend its pause on reciprocal tariffs on imports from China for another year. 
    • “Despite the tariff reductions, goods from China will still face a duty burden of 47%, Trump and U.S. Trade Representative Jamieson Greer said Thursday while traveling to the U.S. from South Korea.” 
  • Kevin Moss, writing in Federal News Network, offers advice to FEHB plan members who need to choose a new plan during the upcoming open season.
    • “If you take no action during Open Season [when your current plan is leaving the FEHB Program for 2026], you’ll be automatically enrolled in GEHA Elevate for 2026. While this plan may work for some, it’s important to review all available FEHB options in your area to find the coverage that best fits your needs.”

From the Food and Drug Administration front,

  • MedTech Dive relates,
    • “The Food and Drug Administration sent a warning letter to Philips related to quality issues at three facilities that manufacture ultrasound equipment and software for heart imaging and telehealth.
    • “The FDA sent the warning letter to Philips on Sept. 9 and posted it on Tuesday. The communication followed inspections in early 2025 of three facilities in Washington, Pennsylvania and the Netherlands.
    • “The FDA raised concerns with Philips’ process for handling complaints and device corrections. Philips has tasked a specific unit with handling complaints, but the company lacks documentation to show that complaints are being evaluated.” 
  • Beckers Hospital Review adds,
    • “Teva Pharmaceuticals has voluntarily recalled more than 580,000 bottles of prazosin hydrochloride, a high blood pressure drug, because of a carcinogenic ingredient. 
    • “In safety and quality testing of the medication, the drugmaker detected N-nitroso Prazosin impurity C, which can increase cancer risk if exposure exceeds acceptable levels set by the FDA. 
    • “The recall is classified as Class II, which the FDA defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A study published Oct. 30 by the American Heart Association found that people have an elevated risk of heart attack and stroke following flu and COVID-19 infection. Researchers reviewed 155 previous studies investigating the association between viral infections and the risk of heart attack and stroke and found that people are four times more likely to have a heart attack and five times more likely to have a stroke in the month after having the flu. Following a COVID-19 infection, people are three times more likely to have a heart attack or a stroke 14 weeks after, with an elevated risk remaining for a year. 
    • “Additionally, the study found chronic infections such as HIV, hepatitis C and varicella zoster virus — which causes shingles — can increase long-term elevated risks of cardiovascular events. Researchers said preventive measures, including vaccination, could be important for reducing the risk of heart attacks and strokes, particularly for individuals who already have heart disease or heart disease risk factors.” 
  • Genetic Engineering and Biotechnology News relates,
    • “As flu season approaches and there is a push for vaccination, a study by Allen Institute scientists has uncovered why vaccines can trigger a weaker response in older adults—aged about 65 years—and suggests how these immune responses might be improved. In what they state is the largest study of its kind, the researchers used techniques including single-cell RNA sequencing (scRNA-seq), proteomics, and spectral flow cytometry to profile the immune systems of younger and older individuals over time.
    • “The findings showed that T cells—key players in coordinating immune responses—undergo profound and specific changes as we age. These changes, the results suggest, are not random or a byproduct of chronic disease and inflammation but are a fundamental feature of healthy aging and will happen to all of us as we get older. The changes could also point to why vaccines, including the annual flu shot and COVID-19 boosters, tend to be less effective in older adults. The scientists suggest that their insights, newly reported in Nature, could open the door to designing more effective vaccines.”
  • The New York Times lets us know,
    • “One of the most popular mental health innovations of the past decade is therapy via text message, which allows you to dip in and out of treatment in the course of a day. Say you wake up anxious before a presentation: You might text your therapist first thing in the morning to say that you can’t stop visualizing a humiliating failure.
    • “Three hours later, her response pops up on your phone. She suggests that you label the thought — “I’m feeling nervous about my presentation” — and then try to reframe it. She tells you to take a deep breath before deciding what is true in the moment.
    • “You read her answer between meetings. “I’m pretty sure my boss thinks I’m an idiot,” you type. The therapist responds the next morning. “What evidence do you have that she thinks that?” she asks. She tells you to write a list of the available evidence, pros and cons.
    • “Text-based therapy has expanded swiftly over the past decade through digital mental health platforms like BetterHelp and Talkspace, which pair users with licensed therapists and offer both live chat and as-needed texting sessions. A new study published on Thursday in the journal JAMA Network Open provides early evidence that the practice is effective in treating mild to moderate depression, finding outcomes similar to those of video-based therapy.”
  • Per NPR
    • “Teens who start using cannabis before age 15 are more likely to use the drug often later in their lives. They are also more likely to develop mental and physical health problems in young adulthood compared to their peers who did not use the drug in adolescence.
    • “Those are the findings of a new study in JAMA Network Open.
    • “This further builds the case that cannabis use in adolescence adverselyaffects the [health] trajectories of those who use it,” says psychiatrist Dr. Ryan Sultan at Columbia University, who wasn’t involved in the new research.
    • “The new study used data from the Québec Longitudinal Study of Child Development. Researchers in Montreal, Canada, have been following more than 1,500 kids since birth into young adulthood to understand the factors that influence their development and their health. Among the various aspects of the kids’ lives and habits scientists have recorded is cannabis use between ages 12 and 17.”
  • Per Health Day,
    • “For patients with irritable bowel syndrome (IBS), the Mediterranean diet (MD) is superior to traditional dietary advice (TDA) as first-line therapy, according to a study published online Oct. 27 in the Annals of Internal Medicine.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports
    • “Weight-loss drugs are propelling a new gold rush for the pharmaceutical industry.     
    • “On Thursday, Eli Lilly LLY delivered a surge in quarterly revenue thanks to its medicines, while Novo Nordisk NOVO.B, the other big player in the market, took the unusual step of lobbing an unsolicited multibillion-dollar bid for a weight-loss-drug startup that had agreed to sell to Pfizer.
    • “Altogether, the moves showed the strength—and allure—of one of the biggest and fastest-growing categories in pharmaceuticals.”
  • and
    • Cigna Group CI logged higher profit and revenue in the third quarter, but the company warned that profits for its pharmacy-benefits business will be squeezed next year.
    • Cigna shares dropped 17% in early trading Thursday, signaling investor concern about the PBM profit warning.
    • The company said during a call with analysts that it expected earnings growth in 2026, but warned that profits for its pharmacy-benefit management unit would drop that year, due to renegotiated contracts with three major clients and costs associated with adopting an ambitious new payment model.
    • Analysts zeroed in on concerns about the PBM’s future margins, and Cigna executives said the new contract terms would continue in the future, but the heightened investment costs would only span 2026 and 2027. 
    • Overall, Cigna said, it expected to return to typical company-level earnings growth targets in 2027 despite the pressure, and it said that its new PBM payment model should ultimately generate profits similar to the current one. 
  • Beckers Hospital Review adds,
    • “Pfizer is pushing back against a $9 billion unsolicited bid from Denmark-based Novo Nordisk to acquire Metsera, calling it an illegal attempt to eliminate a U.S.-based competitor. 
    • “Pfizer said the structure of Novo Nordisk’s proposal — which includes $56.50 per share in cash, plus contingent value rights worth up to $21.25 per share — is designed to circumvent antitrust laws and poses significant regulatory and executional risk, according to an Oct. 30 news release. 
    • “The offer values Metsera at about $6.5 billion in equity and up to $2.5 billion in potential milestone payments, for a total consideration of up to $9 billion, according to Novo Nordisk’s Oct. 30 news release.”
  • Per Fierce Healthcare,
    • “Why did for-profit hospital systems blow past analysts’ expectations this quarter? Short answer—they got paid.
    • “Across the past week’s earnings statements and calls, executives outlined solid demand for care services and no major curveballs surrounding expense lines like labor spending. Both of those trends are expected to continue through the end of this year and into 2026, they said, with other hurdles like elevated supply spend from tariffs not yet creeping into purchasing contracts.”
  • Beckers Hospital Review adds,
    • “A year after flagging a spike in payer denials, Community Health Systems’ top executive says the situation has stabilized.
    • “It has really not gotten any worse,” Interim CEO Kevin Hammons said on the Franklin, Tenn.-based for-profit system’s Oct. 24 earnings call.
    • “On CHS’ October 2024 call, Mr. Hammons said the system was making incremental investments in its centralized financial services processes and teams, as well as its physician advisor program to “continue to advocate for the appropriate classification of care for our patients and payment for the services our health systems provide.”
    • “He said on the Oct. 24 call that CHS is also investing in AI tools, using a combination of third-party vendors as well as internally developed products for its revenue cycle team. 
    • “I would say we’ve been able to kind of hold things stable, which would indicate that the payers are probably also denying more claims,” he said. “We’ve been better at overturning some of those denials in order to kind of keep things status quo.”
  • and
    • identifies “26 hospitals and health systems that received credit rating downgrades from Fitch Ratings or Moody’s Investors Service in 2025.”
  • Per BioPharma Dive,
    • “With quarterly earnings underway, BioPharma Dive is providing a snapshot of some companies’ results and how they’re being received by investors. Today, we’re offering insight into the latest numbers from Alnylam Pharmaceuticals, Biogen, Neurocrine Biosciences and Bristol Myers Squibb.” 
  • Per Fierce Pharma,
    • “With vaccine sales on the decline across the industry, these are tough times for Merck to launch its new pneumococcal shot Capvaxive. But in the third quarter, the company recorded encouraging sales for the vaccine, which is the world’s first pneumococcal shot designed specifically for adults.
    • “Capvaxive generated sales of $244 million in the period, which was up from $129 million in Q2. Over its first four quarters on the market—since the CDC recommended its use in October of last year for people age 50 and older—Capvaxive pulled in sales of $530 million.
    • “[Capvaxive] is off to a very strong start,” Merck chief financial officer Caroline Litchfield said during the company’s quarterly conference call Thursday.”
  • Fierce Healthcare tells us,
    • “Blues-backed pharmacy benefit manager Prime Therapeutics is expanding its partnership with Sempre Health nationwide after finding significant savings in a pilot program.
    • “Blue Cross Blue Shield of North Carolina, a client of Prime, launched with Sempre in 2022. Sempre identifies the members that are taking preferred, single-source drugs to manage chronic needs and automatically surfaces discounts at the pharmacy counter.
    • “Members also receive text message alerts when it’s time for them to refill a prescription, with savings incentives that increase as they refill their key medications on time.
    • “Over the past three years, the partnership with Blue Cross NC has enrolled more than 19,500 members and managed more than 70,000 refills, saving members $4.7 million. It’s with these results under their belts in the initial collaboration that Prime decided to expand the relationship.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of brensocatib (Brinsupri™, Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “ICER’s report on this therapy was the subject of the September 2025 public meeting of the CTAF, one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations“

From the AI front,

  • Beckers Health IT informs us,
    • “After restructuring as a for-profit company, ChatGPT developer OpenAI’s newly named nonprofit arm will dedicate part of $25 billion toward health.
    • “The OpenAI Foundation, which holds a stake in the for-profit valued at $130 billion, is committing the $25 billion to health and curing diseases and technical solutions to AI resilience.
    • “The OpenAI Foundation will fund work to accelerate health breakthroughs so everyone can benefit from faster diagnostics, better treatments, and cures,” OpenAI board chair Bret Taylor wrote in an Oct. 28 blog post. “This will start with activities like the creation of open-sourced and responsibly built frontier health datasets, and funding for scientists.”

In Memoriam

  • OPM Director Scott Kupor shares sad news,
    • “It is with deep sadness I share the news of the passing of Kathleen “Kathy” McGettigan, a former Acting Director of the U.S. Office of Personnel Management and a cherished member of the OPM family.
    • “Although I did not have the privilege of knowing Kathy personally, I have learned how profoundly she influenced this agency and the people who make it what it is today. Those who worked alongside her describe a leader of great integrity, compassion, and commitment — someone who led with both excellence and heart.
    • “Kathy devoted her career to public service, guiding OPM and the federal workforce with wisdom and grace during times of transition. Her impact continues to be felt in the work we do each day and in the community of dedicated public servants she helped shape.
    • “As we reflect on Kathy’s life and contributions, I hope we take a moment to honor her memory — not only through our words, but through our shared commitment to the mission she cared so deeply about: serving the federal workforce and, through it, the American people.
    • “If you would like to read more about her life, you can view Kathy’s obituary: Kathy McGettigan Obituary“
  • RIP

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–

From Washington, DC,

  • CBS News reports,
    • “Senators appeared cautiously optimistic about the direction of bipartisan talks, with key deadlines putting pressure on both sides to reach a resolution to reopen the government. 
    • “Sen. Lisa Murkowski, an Alaska Republican, told reporters she’s more optimistic. She said there’s been a “significant uptick in bipartisan conversation,” reiterating what Thune said earlier in the day.
    • “Sen. Gary Peters, a Michigan Democrat who said he’s part of the conversations, told CBS News that “we’ve been talking regularly throughout the shutdown,” while pointing to the impact of rising health insurance premiums.
    • “So obviously now people are starting to see the impact of these increases now that prices are coming out,” Peters said.
    • “And Democratic Sen. Elissa Slotkin of Michigan said that while a “refusal to meet and have a real conversation” had been holding lawmakers back, now “we’re having those conversations.” 
  • The Wall Street Journal confirms,
    • “The financial pain from the government shutdown is spreading and the legislative options for both Republicans and Democrats on Capitol Hill are narrowing, prompting a pickup in informal talks to resolve the nearly monthlong impasse.
    • “Lawmakers point to deadlines within days that they hope will force a breakthrough before money stops flowing for food-stamp benefits and enhanced healthcare subsidies. The White House, which is ensuring that troops are paid, has urged GOP leaders to not hold votes on stand-alone proposals to pay other government workers or otherwise lessen the impact of the shutdown, sparking angry words on the Senate floor but also potentially hastening a compromise.
    • “Senate Majority Leader John Thune (R., S.D.) told reporters Wednesday that conversations have “ticked up significantly” and said, “hopefully that will be a precursor of things to come.” He said that the focus was on conversations among rank-and-file lawmakers and pointed to moderate Democrats as a way out of the shutdown.
    • “I’m hoping that something here very soon will be fruitful,” he said.
    • “Sens. Catherine Cortez Masto (D., Nev.), Jeanne Shaheen (D., N.H.) and Lisa Murkowski (R., Alaska)—all centrists—agreed with the assessment. “More of the conversation is happening,” Cortez Masto said.”
  • The Paragon Health Institute tells us,
    • On October 28, CMS put out information on [Affordable Care Act] exchange plan premiums and offerings. The data make clear that Obamacare’s underlying subsidies remain extremely generous; taxpayers continue to cover nearly all premium costs for most enrollees. According to CMS:
      • On average, subsidies are projected to cover 91 percent of the lowest cost plan premium in 2026 for eligible enrollees. This is higher than the 85 percent it covered in 2020—the last coverage year before Biden’s temporary COVID-19 credits.
      • The average enrollee’s monthly premium payment for the lowest-cost plan will be $50 in 2026—about $20 less than in 2020.
      • In 2026, nearly 60 percent of eligible re-enrollees will have access to a plan in their chosen category at or below $50 in monthly expense to them—compared to 56 percent in 2020.
      • In 2026, 95 percent of enrollees will have access to three or more Qualified Health Plan (QHP) issuers, compared to 68 percent in 2020. 
  • Per MedTech Dive,
    • “New blood pressure treatments from Medtronic and Recor Medical will now be covered by Medicare.
    • “The Centers for Medicare and Medicaid Services on Tuesday finalized a national coverage determination for renal denervation to treat people with uncontrolled hypertension, a widespread condition that raises the risk of heart disease and stroke.
    • “The decision is expected to increase use of the technology to fill a treatment gap for patients when lifestyle changes and prescription medications have failed to lower their blood pressure.”
  • The American Hospital Association News informs us,
    • “The Consumer Financial Protection Bureau released a notice Oct. 28 clarifying that the Fair Credit Reporting Act preempts state laws on credit reporting, including those regarding medical debt. As a result, medical debt must be included on credit reports, regardless of state laws disallowing the inclusion of medical debt on credit reports.”

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The Food and Drug Administration wants to speed the development of biosimilars, announcing new guidance on Wednesday that would no longer require the makers of copycat biologics to run human trials showing their products are as effective and safe as their branded counterparts.
    • “The FDA agency said the policy shift should make biosimilar development faster and cheaper, estimating that companies could now save $100 million in development costs per product. At a press conference, Commissioner Martin Makary said the move could help create “more competition [and] more choices” for people who need biologic medicines.
    • “Wednesday’s announcement builds on previous FDA initiatives to ease the development and review of biosimilars. In 2024, the agency proposed dropping studies analyzing the effects of “switching” between branded products and biosimilars. That move was designed to make it easier for biosimilars to gain “interchangeability” status, which allows pharmacists to substitute them for a biologic without a doctor’s prescription.” 
    • See FACT SHEET: Bringing Lower-Cost Biosimilar Drugs to American Patients.

From the public health and medical / Rx research front,

  • The American Hospital Association News lets us know,
    • “The Centers for Disease Control and Prevention released an advisory Oct. 29 on three unrelated cases of clade I mpox recently identified in California. The agency said that viral genomic data suggested the cases are likely part of the same cluster and may be linked to a case from August with recent travel to an area with clade I mpox spread. The CDC said there is high suspicion of community spread since the three September cases had no history of recent travel and no obvious common exposure or epidemiological link between them. The agency recommended that laboratories use tests targeting a viral essential gene, as mutations of the virus can impact clade-specific polymerase chain reaction tests. The risk of clade Ib mpox to the public is low, the CDC said.” 
  • Per the University of Minnesota’s CIDRAP
    • Two hotspots for measles activity in the United States—neighboring counties in Arizona and Utah and Upstate South Carolina—are reporting more measles cases, and the Centers for Disease Control and Prevention (CDC) says the United States now has 1,648 confirmed cases this year, 87% of which are outbreak-associated. 
    • The national total is 40 more cases than last week. 
  • and
    • “A meta-analysis of 511 studies on US COVID-19, respiratory syncytial virus (RSV), and influenza vaccines find meaningful protection against severe disease and hospitalization, evidence that can help fill the void in vaccine guidance formerly provided by independent federal review.
    • “The large-scale project, conducted by the Center for Infectious Disease Research and Policy’s (CIDRAP’s) Vaccine Integrity Project (VIP), was published today in the New England Journal of Medicine. CIDRAP, which publishes CIDRAP News, started the VIP to provide science-based information to help people, communities, policymakers, and clinicians make informed vaccine choices.
    • “Contrary to assertions by US Health and Human Services Secretary Robert F. Kennedy Jr., the study shows that “there is absolutely no shortage of data regarding these vaccine products for COVID, flu, and RSV,” co-senior author Caitlin Dugdale, MD, an infectious disease physician at Massachusetts General Hospital, told CIDRAP News. 
    • “In fact, there’s a sea of data that’s far too big for any one person to try to get through,” she added. “The findings of our review really reaffirm the safety and effectiveness of these vaccines.”
    • “VIP scientists and other experts presented initial findings from their analysis in August. Today’s data represent the group’s final peer-reviewed outcomes, adding to the veracity of their results.”
  • NPR relates,
    • “The number of people using injectable obesity treatments is increasing rapidly, and it is leading to declines in obesity, according to a new survey by the Gallup National Health and Well-Being Index.
    • “The obesity rate dropped to 37% of U.S. adults this year, down from a high of 39.9% three years ago, according to the survey.”
    • “The survey found that the number of Americans taking drugs like semaglutide (which include the brands Ozempic and Wegovy) or tirzepatide (under the brands Zepbound and Mounjaro) for weight loss more than doubled over the past year and a half. That’s 12.4% of respondents taking the drugs compared with 5.8% in February 2024, when Gallup first measured it. The new treatments are in a class of drugs known as GLP-1 agonists, and this generation of very effective GLP-1 agonists were approved for obesity treatment in the U.S. market in 2021.”
  • Healio adds,
    • “GLP-1s hold promise as a potential treatment for alcohol and substance use disorders, according to an expert endocrine consult published in the Journal of the Endocrine Society. 
    • “Treatment options for alcohol and substance use disorders are currently limited, according to Lorenzo Leggio, MD, PhD, clinical director, deputy scientific director and chief of the translational addiction medicine branch of the National Institute on Drug Abuse Intramural Research Program of the NIH, and colleagues. The researchers discussed how GLP-1s are tied to several changes in the central nervous system and suggested the activation of GLP-1 receptors could reduce “drug-seeking and consummatory behaviors.
    • “This research is very important because alcohol and drug addiction are major causes of illness and death, yet there are still only a few effective treatment options,” Leggio said in a press release. “Finding new and better treatments is critically important to help people live healthier lives.”
  • MedPage Today notes,
    • “For women over 35 considering fertility preservation, freezing their eggs as soon as possible may be vital for increasing the probability of having at least one live birth, a retrospective cohort study found.
    • “Among women who froze their eggs at 35 or older, the probability of live birth decreased by 13% per year (OR 0.79, 95% CI 074-0.84), reported Michelle Bayefsky, MD, from RMA of New York and Mount Sinai School of Medicine in New York City, at the American Society for Reproductive Medicine annual meeting.
    • “Nearly half (49%) of patients who froze their eggs between 35 and 37 achieved at least one live birth while only 13% of patients who underwent oocyte cryopreservation over age 42 did.”
  • Per Health Day,
    • “Trauma exposure and traumatic stress are common among adolescents, according to a study published online Oct. 27 in Pediatrics.
    • “Brooks R. Keeshin, M.D., from the University of Utah in Salt Lake City, and colleagues described rates of trauma exposure and traumatic stress symptoms among youth aged 11 to 19 years who presented to primary care clinics for well-child visits between July 2022 and June 2024. Youth completed the Triple Screen, including the Pediatric Traumatic Stress Screening Tool, the Patient Health Questionnaire-Adolescent version, and the Generalized Anxiety Disorder 7 as part of routine care; the Columbia Suicide Severity Rating Scale was completed when indicated.
    • “Overall, 15.5 percent of 24,675 youth reported trauma exposure and 7.5 percent reported moderate or high symptoms of traumatic stress. The researchers found that the likelihood of reporting a traumatic experience was higher for female and Hispanic youth. High anxiety and/or depression symptom scores were seen in only half of youth with high traumatic stress symptoms. Older, female, Hispanic individuals and those with prior mental health diagnoses more often had high traumatic stress symptoms. Compared with those with low or moderate traumatic stress, adolescents with trauma and high traumatic stress were 10 times more likely to have a high risk for suicide, representing 48 percent of all youth at high risk for suicide.”
  • Per Fierce Pharma,
    • “Merck & Co. and Eisai previously had high hopes for their Keytruda-Lenvima combination in a liver cancer subtype based on positive progression-free survival data, but now the combo’s promise has once again been dented by a miss on another endpoint.
    • “PD-1 inhibitor Keytruda and tyrosine kinase inhibitor (TKI) Lenvima, when added to standard transarterial chemoembolization (TACE), couldn’t help patients with unresectable, non-metastatic hepatocellular carcinoma (HCC) live longer compared to TACE alone, Merck and Eisai’s phase 3 LEAP-012 study has found.
    • “The overall survival miss was determined at a pre-specified interim analysis, Merck said in an Oct. 29 press release, as the likelihood of meeting the threshold for statistical significance in the endpoint at a future analysis was deemed “low” by the companies.
    • “With that, the partners are shutting the study down, although further analysis of the data is ongoing.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health raised its earnings expectations for 2025 after the healthcare behemoth’s Aetna health insurance and pharmacy units improved their performance in the third quarter.
    • “CVS now expects full year adjusted earnings between $6.55 to $6.65 per share, up from its previous guide of between $6.30 to $6.40 per share, according to financial results released Wednesday. 
    • “However, the company swung to a loss in the third quarter, driven by a $5.7 billion goodwill impairment charge linked to CVS’ healthcare delivery assets — particularly its move to decelerate growth of its Oak Street Health senior care clinics, CEO David Joyner said on an earnings call Wednesday morning.” 
  • and
    • “Centene posted a net loss of $6.6 billion in the third quarter after recording a massive charge to reflect the company’s waning value amid challenging market conditions, including Republican cuts to the healthcare system.
    • “Centene recorded a non-cash goodwill impairment charge of $6.7 billion, driving the payer deep into the red. Without the charge, which has no effect on Centene’s cash or underlying operations, the company would have posted a small profit.
    • “Overall, executives said they were pleased with Centene’s performance in the quarter, including keeping a lid on spiking medical costs in Medicaid and the Affordable Care Act exchanges. Centene increased its full-year earnings outlook following the results.”
  • and
    • “Universal Health Services raised its financial forecast for 2025 on Monday, after the operator posted third quarter revenues that increased 13.4% year over year to $4.5 billion. 
    • “The for-profit operator attributed the revenue increase in part to a $90 million boost from Washington D.C.’s recently approved Medicaid supplemental payment program, as well growth in its acute care volumes.
    • “The health system now expects to take between $17.3 billion and $17.4 billion in revenue for the year, up from its previous forecast of $17.1 billion to $17.3 billion.”
  • Fierce Healthcare adds,
    • “In Teladoc Health’s third-quarter 2025 financial results, released Wednesday, the company reported falling U.S. revenue along with an uptick in its international business.
    • “The telehealth giant reported $626.4 million in third-quarter revenue, down 2% year-over-year, and a $49.5 million loss, or a loss of 28 cents per share, for the quarter that ended Sept. 30. 
    • “The company’s adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) was down 16% year-over-year, to $69.9 million.”
  • and
    • “Pharma giant Eli Lilly tapped Walmart to offer in-store pickups of Zepbound vials, marking the first retail collaboration for its direct-to-consumer platform LillyDirect.
    • “Walmart, which operates nearly 4,600 pharmacies nationwide, will be the first in-store pickup pharmacy for LillyDirect’s self-pay single-dose vials of the weight loss drug, according to the company. It marks the first time patients using LillyDirect, the company’s DTC healthcare platform, can access self-pay pricing for Zepbound vials at a retail pharmacy location.
    • “The offering will be available by mid-November, the companies said. The service provides consumers with additional convenience, access and choice in how they get their medication, the companies said.”
  • Alan Fein, who writes the Drug Channels blog, offers his thoughts on the Cigna/Evernorth decision to move away from drug rebates.
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of semaglutide (injectable Wegovy®, and a yet to be approved oral formulation) (Novo Nordisk) and tirzepatide (Zepbound®) (Eli Lilly and Company) for the treatment of obesity. ICER is also assessing how these treatments affect additional obesity-related outcomes.
    • “Over the past few years, semaglutide and tirzepatide have revolutionized the management of obesity,” said ICER’s Chief Medical Officer, David Rind, MD, MSc. “In addition to typically producing meaningful weight loss, these therapies reduce cardiovascular risk and improve multiple other aspects of the metabolic syndrome as well as additional obesity-related conditions.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on November 13, 2025. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.” * * *
  • Healthcare Dive relates,
    • “National insurers are generally good at making accurate negotiated rate data available in compliance with federal price transparency rules, although there’s still room for improvement, according to a new analysis from transparent pricing company Turquoise Health.
    • “That’s likely due to large payers having more resources to issue and monitor machine-readable files of rates. Small and regional payers tend to be less successful, Turquoise found.
    • “Still, the company cautioned the results should not be taken as a true measure of compliance, given only states or the HHS can determine that. Instead, Turquoise said its goal with the report is to prevent payer transparency from stagnating or worsening by creating more accountability.”
  • Per MedTech Dive,
    • “Thermo Fisher Scientific will acquire clinical trial data firm Clario Holdings for $8.9 billion in cash, the companies announced Wednesday. Clario is currently held by a shareholder group led by Astorg and Nordic Capital, Novo Holding and Cinven.
    • “In addition, Thermo has agreed to pay $125 million in January 2027, and up to $400 million in payments based on the performance of the business in 2026 and 2027. 
    • “Clario integrates clinical trial endpoint data from devices, sites and patients. The company is expected to complement Thermo’s existing clinical research services, and to drive costs out of the drug development process for customers, J.P. Morgan analyst Casey Woodring wrote in a research note.” 
  • Per Fierce Pharma,
    • “Picking a date for a press conference in Puerto Rico in the middle of hurricane season can be risky business. But, these days, there’s no stopping Eli Lilly’s whirlwind of manufacturing investment announcements.
    • “Wednesday, the Indianapolis company revealed its plan to spend $1.2 billion to upgrade its manufacturing complex in Carolina, Puerto Rico. The outlay comes amid a deluge of commitments by Lilly to bolster its ability to produce drugs in the U.S. Since 2020, the company has earmarked more than $50 billion to increase its domestic manufacturing capabilities, it said.
    • “Lilly said the investment at its Puerto Rico site will allow it to manufacture more of its “growing portfolio” of oral medicines, which include treatments in neuroscience, oncology, immunology and cardiometabolic health.”

In Memoriam

  • The Washington Post reports,
    • Ruth Lawrence, who pioneered the science of breastfeeding, dies at 101. A trailblazer for women in medicine, she dedicated her career to teaching mothers and medical professionals about the benefits of breastfeeding.
  • The Miami Herald reports,
    • “Dr. Michael Zinner, who helped establish the Miami Cancer Institute of Baptist Health South Florida, died Saturday at his Coral Gables home from Stage IV pancreatic cancer after a self-diagnosis and tests confirmed the disease in August 2024. Zinner, 80, was with his family, his son Darren said. The same disease killed his third wife, Rhonda “Ronny,” in 2014 and inspired his move back to Miami to lead the cancer institute.
    • “Sad and tragic to have passed from a disease from which he has such deep experience, and even sadder that he is no longer able to pass on that knowledge to many more people,” his son Dan Zinner said.”

RIP.

Tuesday report

David Ermer–Congress, FDA, Medical / Rx research, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “Vice President JD Vance said Tuesday he believes U.S. military members will be paid at the end of the week, though he did not specify how the Trump administration will reconfigure funding as pain from the second-longest shutdown spreads nationwide.
    • “The funding fight in Washington gained new urgency this week as millions of Americans face the prospect of losing food assistance, more federal workers miss their first full paycheck and recurring delays at airports snarl travel plans.
    • “We do think that we can continue paying the troops, at least for now,” Vance told reporters after lunch with Senate Republicans at the Capitol. “We’ve got food stamp benefits that are set to run out in a week. We’re trying to keep as much open as possible. We just need the Democrats to actually help us out.”
    • “The vice president reaffirmed Republicans’ strategy of trying to pick off a handful of Senate Democrats to vote for stopgap funding to reopen the government. But nearly a month into the shutdown, it hasn’t worked. Just before Vance’s visit, a Senate vote on legislation to reopen the government failed for the 13th time.”
  • Govexec adds,
    • “William Shackelford, national president of the National Active and Retired Federal Employees Association, wrote in his own letter to lawmakers Tuesday that the so-called “clean CR” passed by the House is a misnomer, in light of House Republicans’ refusal to allow Democratic input into the bill’s contents and the White House’s efforts both before and during the shutdown to impound or otherwise redirect funding, contrary to appropriations law and the 1974 Impoundment Control Act. • • *
    • “From NARFE’s perspective, Democrats should scale back their demands for the extension of ACA subsidies as a condition for reopening the government. And House Speaker Mike Johnson needs to call his chamber back to Capitol Hill, Shackelford argued.”
  • and
    • “The Trump administration on Oct. 21 released a memo to guide agencies on how to implement a directive establishing legally untested processes to speed up the repeal of regulations. 
    • “In April, the president directed agencies to forgo notice and comment requirements when repealing rules that are deemed unconstitutional or unlawful in light of recent Supreme Court rulings that weakened agencies’ regulatory power. When an agency promulgates a new rule, or revokes one, it must seek, respond to and potentially incorporate public comment on the proposal. That process usually takes at least a year. 
    • “The administration, however, argued that it does not have to take this step because of the “good cause” exception in the Administrative Procedure Act, the law that sets rulemaking requirements. The exception provides that agencies do not have to perform notice and comment if doing so would be “impracticable, unnecessary or contrary to the public interest.”
    • “To date, agencies do not appear to be fully maximizing their energy in carrying out these directives,” wrote Jeffrey Clark, acting administrator of the Office of Information and Regulatory Affairs, the White House office that reviews most federal regulations.” 

From the Food and Drug Administration front,

  • MedPage Today relates,
    • “Lawmakers at the helm of the Senate Special Committee on Aging have proposed a sweeping series of changes that could transform the way the government safeguards the quality of essential generic drugs.
    • “Citing a recent ProPublica investigation, the senators said the FDA should alert hospitals and other group purchasers when foreign drugmakers with serious safety and quality failures are given a special pass to send their products to the U.S.” * * *
    • “After a hearing last month, Scott and Gillibrand demanded the FDA provide an immediate accounting of all foreign generic drugmakers allowed to skirt import bans. And last week, they sent a letter to HHS Secretary Robert F. Kennedy Jr. seeking a briefing about the drug supply chain and the risk of shortages. The letter also cited ProPublica‘s reporting about the FDA’s exemptions from import bans, saying they could pose “a threat to drug safety for American consumers.” * * *
    • “HHS, which oversees the FDA, declined to comment about the investigative report or the letter to Kennedy when contacted by ProPublica, saying the agency would respond directly to the senators.
    • “The 34-page report largely focuses on shoring up domestic manufacturing. The senators cited an academic study released this year that found generic drugs made in India were tied to far more hospitalizations, deaths, and other adverse events than the equivalent medications manufactured in the U.S.
    • “We let the industry go offshore for cost reasons without adjusting the regulatory infrastructure to be able to handle it appropriately,” said Ohio State University professor John Gray, PhD, who co-authored the study. “There’s this race to the bottom … that leads to fragility and shortages and also potential quality issues.”
    • Notably, the senators suggested the Department of Defense could help launch a “federal buyer’s market” that prioritizes the purchase of drugs from domestic manufacturers. The federal government, with agencies that include the Department of Veterans Affairs, is the largest purchaser of drugs in the U.S.
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has shared details about a new recall impacting more than 140,000 bottles of a popular statin. This is a Class II recall, which means taking the drug “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
    • “The medication in question is atorvastatin calcium, a generic version of Lipitor manufactured by India-based Alkem Laboratories and distributed by New Jersey-based Ascend Laboratories. The drug is commonly prescribed to help patients lower their cholesterol levels as well as reduce their risk of adverse cardiovascular events. 
    • “According to the FDA, several lots of atorvastatin calcium were recalled due to “failed dissolution specifications.” This means the drug is not dissolving correctly, which can impact its ability to lower a patient’s cholesterol as intended.
    • “Ascend Laboratories initiated the recall back in September. It was classified a Class II recall on Oct. 10. Click here for additional details.” 

From the judicial front,

  • Federal News Network tells us,
    • “The Trump administration’s latest round of federal employee layoffs will remain on hold, for now.
    • “A federal judge in San Francisco granted a preliminary injunction on Tuesday that will indefinitely block the Trump administration from proceeding with widespread reductions-in-force for about 4,000 federal employees, or issuing new RIF notices, while the case proceeds through the court.
    • “U.S. District Court Judge Susan Illston said her preliminary injunction will block the Trump administration from issuing any more RIF notices or implementing RIF notices that have been issued “because of the shutdown.” The preliminary injunction, however, will not block RIF notices that were sent before the shutdown.”
  • ABC News reports,
    • “On Tuesday, more than two dozen states and the District of Columbia filed a lawsuit in Massachusetts suing the Trump administration over the impending loss of SNAP benefits amid the government shutdown.
    • “About 42 million Americans are poised to lose their Supplemental Nutrition Assistance Program (SNAP) benefits when federal funding comes to a halt on Nov. 1. The U.S. Department of Agriculture (USDA) has said it would not use emergency funds to give a lifeline to program funding. The states are seeking to have the court order USDA to use all available funds to keep SNAP benefits funded in November.”

From the public health and medical / Rx research front,

  • The American Hospital Association informs us,
    • “The American Heart Association released a study Oct. 28 that found disruptions to people’s circadian rhythm can increase their risk of cardiovascular disease and other conditions such as obesity, Type 2 diabetes and high blood pressure. The study said that disruptions can be caused by light exposure and other factors such as mistimed sleep, meals and exercise. “Multilevel interventions and policy changes are needed that promote education on proper timing and regularity of sleep-wake cycles and meal schedules and facilitate improvements in, for instance, workplace and neighborhood environments,” the study notes.”
  • Medscape warns
    • Severe obesity (BMI ≥ 40 kg/m²) is no longer rare in clinical practice. According to the CDC, 9.2% of US adults live with class 3 obesity, and prevalence continues to rise, particularly among younger adults. The National Health and Nutrition Examination Survey revealed that 1 in 270 Americans now has a BMI ≥ 60, a category that did not exist until the early 2000s.
    • This shift has profound clinical implications. People with severe obesity face higher rates of cardiometabolic disease, musculoskeletal limitations, and psychosocial distress. In a diverse US database, class 3 obesity was strongly associated with obstructive sleep apnea, type 2 diabetes, and metabolic-dysfunction associated steatotic liver disease (hazard ratios of 10.94, 7.74, and 6.72, respectively). Yet this growing population remains chronically underserved. * * *
    • “The past 5 years have transformed expectations. Powerful new nutrient-stimulated hormone therapies encompassing GLP-1 semaglutide and the dual GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist tirzepatideroutinely produce average weight loss of 15%-23% in clinical trials, with some participants losing > 30% of body weight. These reductions improve type 2 diabetes, steatotic liver disease, sleep apnea, and quality of life. Semaglutide and tirzepatide have also reduced cardiovascular risk in high-risk populations, underscoring obesity treatment as an intervention that both treats and prevents cardiometabolic disease. 
    • “Access and affordability, however, remain challenging. Current medications also appear to have a therapeutic ceiling, renewing interest in and consensus around bariatric surgery for individuals with BMI ≥ 60.” 
  • Per BioPharma Dive,
    • “Merck & Co. may be able to expand use of its kidney cancer drug Welireg after it hit the main goal in two Phase 3 trials in people with less-advanced disease.
    • “In one trial, adding Welireg to Merck’s immunotherapy Keytruda following the surgical removal of cancerous tissue kept people disease-free longer than Keytruda alone. In the other, a combination of Welireg and Eisai’s Lenvima helped delay progression better than Exelixis’ Cabometyx in people who relapsed after treatment with Keytruda.
    • “Study success in the post-surgical “adjuvant” setting could prove especially lucrative for Merck, potentially nearly tripling expected revenue in that line of care to more than $6 billion, Leerink Partners analyst Daina Graybosch wrote in a note to clients.”
  • and
    • “GSK will pay privately held Empirico $85 million for the rights to an experimental therapy that may treat a range of patients with chronic obstructive pulmonary disease, or COPD.
    • “Empirico is currently testing the drug, known as EMP-012, in a Phase 1 clinical trial. Once that research is complete, GSK will take over development and handle regulatory filings and marketing if the medicine wins approval, the two companies said Tuesday.
    • “As part of the deal, Empirico may receive payments of as much as $660 million more from GSK if the drug reaches certain development, regulatory and commercial milestones. Empirico will also be eligible for tiered royalties on worldwide sales.”
  • Genetic Engineering and Biotechnology News discusses the discovery of a new antibiotic Against found in Streptomyces coelicolor that is potent against resistant bacteria. “The next step in the development of the antibiotic will be pre-clinical testing.”
  • Per MedTech Dive,
    • “Medtronic shared three-year data on Sunday for its renal denervation device, Symplicity Spyral.
    • “The company linked the product to significant reductions in two measures of systolic blood pressure.
    • “Researchers published the results in the wake of a consultation about Medicare coverage of RDN, which Medtronic said could drive growth.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth seems to be making progress on righting the ship, beating Wall Street’s expectations in the third quarter and raising its 2025 earnings outlook on Tuesday.
    • “During a call with investors, CEO Stephen Hemsley said the company is on track for “solid earnings growth” next year, citing UnitedHealth’s “operational rigor” and “more prudent pricing.” UnitedHealth is aiming for double-digit growth in 2027, Hemsley said.
    • “UnitedHealth is preparing for significant membership losses next year as it prioritizes this earnings recovery. The company expects to lose about 1 million Medicare Advantage members and shrink its Affordable Care Act enrollment by approximately two-thirds in 2026.”
  • and
    • “Community Health Systems brought in revenues that were in-line with company expectations during the third quarter, aided by a legal settlement, payer mix improvement and the approval of two new Medicaid state-directed payment programs.
    • “The Tennessee-based system reported $3.1 billion in operating revenue during the third quarter, down slightly year over year but still high enough to beat Wall Street’s expectations, according to an analyst note published by Jefferies on Friday.
    • “CHS said it plans to continue its hospital divestiture strategy. More sales are in the works and could close prior to year end, according to executives.”
  • and
    • “HCA Healthcare raised its full-year profit and revenue outlook on Friday after newly approved state supplemental payment programs in the third quarter helped boost the for-profit’s revenues past Wall Street expectations.
    • “The operator now expects revenue between $75 billion and $76.5 billion, and net income between $6.5 billion and $6.72 billion for 2025.
    • “Rising same-facility equivalent admissions and higher surgical volumes also contributed to HCA’s $19.2 billion in revenue for the third quarter — a 9.6% year-over-year increase.”
  • Per Fierce Healthcare,
    • “A strong third quarter has Tenet Healthcare again raising its 2025 guidance and planning an additional $150 million of capital expenditure investments within its hospital segment to fuel future organic growth, according to earnings results announced Tuesday morning.
    • “The public for-profit beat analysts’ consensus estimates for the quarter via a combination of steady demand and volume growth, per-case revenue growth and a tight hold on expenditures such as labor, executives explained to analysts on Tuesday’s quarterly earnings call.
    • “Both of the company’s segments performed well, though it was the acute hospital unit’s outperformance that fueled a $50 million raise to the 2025 adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) outlook range’s midpoint—a bump that follows the summer’s $395 million guidance raise and brings Tenet to an expected 13% increase over 2024’s adjusted EBITDA.”
  • and
    • “It has been a complicated year in Medicare Advantage, and the team at Aetna—the third-largest player in this market—is aiming to double down on what’s worked to navigate the choppy waters.
    • “Jeff Fernandez, president of Medicare at Aetna, joined the company in July but is a veteran of the Medicare Advantage (MA) space, with stints at Humana and Ochsner Health Plan. He told Fierce Healthcare in an interview that while this market is no stranger to headwinds, it’s rare to see so many challenges come together at once.
    • “Public policy changes, utilization fluctuations and competitive dynamics all play a role at one time or another, he said, but “usually, you only have to deal with them one at a time.”
    • “It has injected a lot more volatility into the marketplace for Medicare Advantage,” Fernandez said. “I think Aetna’s view of the world is, well, we’ve got to look at what’s worked in the past, perhaps refine it, make it better and double down on certain things.”
  • Per Beckers Clinical Leadership,
    • “Florida has 15 hospitals included on Healthgrades’ Top 50 Best Hospitals for Surgical Care list, the most of any U.S. state. Healthgrades published its 2026 Specialty Excellence Awards Oct. 28.
    • “Healthgrades evaluated about 4,500 hospitals across 31 procedures and conditions for the awards. The Surgical Care Excellence Award specifically evaluates clinical outcomes across 15 in-hospital surgical procedures: back and neck surgery (except spinal fusion), back and neck surgery (spinal fusion), bowel obstruction, carotid procedures, cholecystectomy, colorectal surgeries, coronary bypass surgery, hip fracture repair, peripheral vascular bypass, prostate removal surgery, resection or replacement of abdominal aorta, total hip replacement, total knee replacement, upper gastrointestinal surgery and valve replacement surgery.
    • “In-hospital complications, in-hospital mortality and 30-day mortality are also factored into Healthgrades’ evaluation.”
    • The article lists the hospitals that made the Top 50 list.
  • Bloomberg Law reports,
    • “Cigna Group’s announcement that it will end the highly criticized practice of accepting back-end drug manufacturer rebates prompted surprised cheers from some corners of the drug supply chain, even as industry observers questioned whether the company’s plans will truly improve transparency and reduce prices.
    • “Cigna’s pharmacy benefit manager subsidiary Express Scripts—one of the nation’s largest PBMs—plans to phase out rebates for its fully insured plans by 2027. The company also plans to phase them out with self-insured employer plans by 2028. Bloomberg News first reported the announcement Monday.” * * *
    • “The Pharmaceutical Research and Manufacturers of America did not say whether it expected drugmakers to lower list prices but said Cigna’s plan is a “step in the right direction that will lower the out-of-pocket costs for patients at the pharmacy.”
    • “CVS Health and UnitedHealth have said they pass through nearly all rebates, though it’s not clear how many of their self-insured plan sponsors pass those rebates to consumers at the point of sale.”
  • Per Beckers Health IT,
    • “CVS Health intends to close 16 Oak Street Health clinics two years after acquiring the senior-focused primary care chain for $10.6 billion.
    • The healthcare giant will shutter the centers by the end of February 2026 and continue to have 230 Oak Street Health clinics across 27 states. CVS is scaling back after originally planning to open 300 of the locations, which serve older adults on Medicare.
    • “The move positions Oak Street Health for sustainable, long-term growth as we continue to navigate external challenges, such as elevated medical costs, CMS risk adjustment model changes and health plan payer dynamics,” a CVS spokesperson told Becker’s. “We continue to believe in Oak Street Health and its proven care model to deliver better clinical outcomes for our patients.”
  • Per Fierce Pharma,
    • “Alongside the U.S. government’s overhaul of the federal vaccine infrastructure, influenza vaccination rates in the country have plummeted below the expectations of a key player in the space. That company, CSL, is now delaying a move to part ways with its vaccine business as a result.
    • “Oct. 28, at its annual general meeting in Australia, CSL’s chairman Brian McNamee and its CEO Paul McKenzie provided investors with an update about the company’s intent to separate out its vaccine division, CSL Seqirus. In August, the company announced its intention to spin off the division into a publicly traded firm on the Australia Stock Exchange by next June, but, now, that will not happen as planned. 
    • “In prepared remarks (PDF) to investors, McNamee explained that “heightened volatility in the current US influenza vaccine market” has caused the company to conclude its “previously proposed demerger timing will not fully capture Seqirus’ value potential.” 
    • “Timing will be revisited when we are confident that market conditions would support the maximisation of shareholder value,” McNamee added, according to the prepared remarks.” 
  • and
    • “Shortly after taking the reins at BioMarin, CEO Alexander Hardy laid out three paths the company could take for its struggling hemophilia A gene therapy, Roctavian. A year after opting to shrink the drug’s commercial reach, BioMarin has now flipped back to option C: a divestiture.
    • “After booking $3 million in third-quarter sales for the $2.9 million drug, the company has decided to pursue “options to divest Roctavian and remove it from our portfolio,” Hardy said in an Oct. 27 earnings press release.
    • “We continue to believe Roctavian has an important role to play in the treatment of hemophilia A and are therefore evaluating out-licensing options for this innovative gene therapy,” Hardy explained. “This decision is consistent with BioMarin’s portfolio strategy and offers the most promising opportunity for ensuring continued patient access to Roctavian.”
    • “While it explores out-licensing opportunities, the company will still make the drug available in its three markets the—U.S., Germany and Italy—and “continue to provide support and monitoring” for those already treated, it said.”

From the AI front,

  • JAMA lets us know,
    • “Question How does referral to a lifestyle intervention exclusively driven by artificial intelligence (AI) compare with referral to a human coach–led Diabetes Prevention Program (DPP) lifestyle intervention?
    • “Findings  In this randomized clinical trial involving 368 adults with overweight or obesity and prediabetes, 31.7% of participants randomized to referral to an AI-led DPP and 31.9% of participants randomized to referral to a human-led DPP group achieved the primary composite outcome (5% weight loss, 4% weight loss plus 150 minutes of physical activity per week, or an absolute hemoglobin A1c reduction of ≥0.2 percentage points with hemoglobin A1c maintained at <6.5% throughout the study duration) at 12 months, a difference that met the prespecified noninferiority criterion of 15%.
    • “Meaning Among adults with prediabetes and overweight or obesity, a fully automated AI-led DPP may be a viable alternative to a DPP led by human coaches.”
  • The Wall Street Journal reports,
    • “Drugmaker Eli Lilly has teamed up with artificial-intelligence chip designer Nvidia to build what the companies say will be the most powerful supercomputer run by a pharmaceutical company to boost the discovery of new medicines.
    • “Lilly, which makes the popular weight-loss drug Zepbound and treatments for diabetes and cancer, said the supercomputer and its AI capabilities will allow it to identify new molecules and to speed up the typical yearslong development timelines. 
    • “Indianapolis-based Lilly also will tap the system for other functions such as improving clinical trials, manufacturing processes and sales.
    • “The companies, which announced the partnership Tuesday, declined to disclose financial terms of the deal. Lilly said some of the Nvidia equipment arrived at the company’s Indianapolis data center over the weekend. Lilly expects the system to be online by January.”
  • MedTech Dive adds,
    • “Johnson & Johnson MedTech will partner with Nvidia, incorporating artificial intelligence into a surgical robot used in kidney stone procedures, the companies announced Tuesday.
    • “The medical device giant will use AI-driven simulation to develop its Monarch platform for urology. For example, simulated clinical scenarios and patient anatomy can be used to model kidney stone procedures.
    • “J&J plans to make the urology platform commercially available in the U.S. in 2026.”

Weekend update

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

From Washington, DC

  • Federal News Network reports,
    • “Many federal employees are feeling a financial hit, as the second-longest government shutdown drags on with no end in sight.
    • “About 1.4 million federal employees missed a full paycheck this week, according to data analysis from the Bipartisan Policy Center. About half of those employees are furloughed, and the rest are working without pay. * * *
    • More than 13,000 air traffic controllers at the Federal Aviation Administration are among those who are about to miss their next paycheck.
    • “Transportation Secretary Sean Duffy told reporters on Friday that air traffic controllers will see a “big, fat zero” on their next paycheck next Tuesday. He previously said there’s been a slight uptick in air traffic controllers calling out sick amid the shutdown.
    • “Duffy said that, before the shutdown, short staffing accounted for about 5% of flight delays on any given day. He said that during the shutdown, short-staffing accounts for 53% of delays.
    • “You can, and very well may see delays in the system. That’s because our priority is you getting from Point A to Point B and getting there safely. I’m less concerned about you getting there on time.”
    • “Nick Daniels, president of the National Air Traffic Controllers Association, said air traffic controllers are “showing up every single day under immense stress,” which can impact their focus on the job. He said some controllers are taking on second jobs to cover their bills during the shutdown.”
  • Govexec adds,
    • “When the new month flips over,” said a Defense Department civilian employee based in Germany, “I have no idea what I’m going to do.” 
    • “For civilian federal employees stationed overseas, the government shutdown—poised to enter its fourth week after a weekend of inactivity in Congress—is bringing a range of unique challenges. One such difficulty stems from employees not just missing their normal pay, like their domestic colleagues, but also their various government-provided housing allowances and other stipends.” 
  • The Wall Street Journal relates,
    • “Top U.S. and Chinese negotiators sounded a positive note on weekend trade talks, hailing what they called constructive discussions ahead of a meeting between President Trump and Chinese leader Xi Jinping planned for this week.
    • “I think we have a very successful framework for the leaders to discuss on Thursday,” U.S. Treasury Secretary Scott Bessent said after two days of trade negotiations in the Malaysian capital. * * *
    • “Trump arrived in Kuala Lumpur on Sunday for a regional gathering of Southeast Asian leaders, his first stop on a trip that will include Japan and South Korea, where he is expected to meet Xi.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Cancer rates are climbing among people in their 20s, 30s and early 40s. But while researchers are still working to better understand what could be driving the perplexing rise, experts say there are steps young people can take to help lower their risk.
    • “Historically, cancer’s been bad luck, bad genetics,” said Arif Kamal, chief patient officer for the American Cancer Society. “It’s this thing that sneaks up on you when you’re not looking for it, and it affects your life in a way that you couldn’t do anything about.”
    • “A growing body of research, however, has examined how lifestyle choices and environmental exposures contribute to the disease. Those factors, unlike genetics, can be controlled to some degree.
    • “What we’re trying to do is build the healthy habits to keep trouble away over time, and you can do that now to invest in a future with less cancer in it,” Kamal said. “The only way we’re going to continue to bend the curve of the number of people getting diagnosed with cancer is really going to be changing how we live in our 20s and 30s.”
    • Here’s what Kamal and other experts say you can do about the cancers that are rising fastest among younger people, including breast and colorectal cancer.
      • Focus on your health
      • Know your personal and family health history
      • Pay attention to symptoms’
      • Advocate for yourself
  • Per JAMA Network,
    • “Question  What is the relative importance across a diverse set of community factors for explaining county-level differences in screening, prevalence, and mortality rates for breast, lung, prostate, and colon cancers?
    • Findings  In this cross-sectional study including all US counties, random forest modeling found that the relative explanatory importance of community measures on cancer screening, prevalence, and mortality rates differed, both within and across cancers. Geospatial patterns also varied, revealing regional and county-level needs.
    • “Meaning These findings suggest that the relative importance of community factors and specific local and regional needs together can inform prioritization and direct resources to the most opportune focus areas to impact cancer outcomes.
  • Per MedPage Today,
    • “A non-hormonal treatment for menopausal moderate-to-severe vasomotor symptoms that just nabbed FDA approval was safe and well-tolerated up to 1 year of treatment, according to a pooled-data analysis.
    • “It is my great and esteemed pleasure to announced that the FDA just hours ago approved elinzanetant [Lynkuet],” said James Simon, MD, of George Washington University and IntimMedicine Specialists in Washington, in a presentation Friday at the Menopause Society (TMS) annual meeting.
    • “Elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist, “represents another important non-hormonal option that all of us can use in treating our patients with vasomotor symptoms,” he added.”
  • and
    • “Postmenopausal women using hormone therapy (HT) saw significantly greater weight loss while taking the dual GIP/GLP-1 receptor agonist tirzepatide (Zepbound) than their counterparts not using HT, according to a retrospective study.” * * *
    • Ultimately, postmenopausal women using HT had the greatest total body weight loss (TBWL) at 19.9%, reported Regina Castaneda, MD, of the Mayo Clinic Florida in Jacksonville, at the Menopause Society annual meeting. Among postmenopausal women without HT, TBWL was 15.6% (P=0.02). TBWL was 18.7% for premenopausal women and 18.6% for perimenopausal women, neither of which differed significantly from postmenopausal plus HT.
    • Indeed, “tirzepatide led to substantial weight loss across all reproductive states,” Castaneda said. “However, the postmenopausal women using hormone therapy achieved significantly greater weight loss compared to those not using hormone therapy, with outcomes closely resembling those of the pre- and perimenopausal women.”

From the healthcare business front,

  • The Wall Street Journal reports,
    • “Novartis NOVN is acquiring Avidity Biosciences RNA in a $12 billion deal that the Swiss drugmaker said would further boost its long-term focus on treating neuromuscular disorders.
    • “The company on Sunday said it had entered into an agreement to buy Avidity, a San Diego-based biotech. Novartis won’t acquire a separate Avidity subsidiary focused on developing early-stage treatments for heart diseases.
    • “Under the deal, Avidity shareholders would receive $72 a share, a 46% premium to its Friday close. 
    • “Avidity is developing gene-based drugs that use an emerging technology known as antibody oligonucleotide conjugates to deliver RNA treatment to muscles. The company is developing experimental drugs based on the technology to treat forms of muscular dystrophy, a multibillion-dollar market. 
    • “The technology, according to Avidity, promises to take RNA therapies to parts of the body where older classes of drugs couldn’t reach or had trouble reaching.”
  • Per HR Dive,
    • “According to HUB International’s 2026 Benefits Cost Trend report, updated Monday, researchers see the costs of benefits going up — with pharmacy being considered a driving factor.
    • “High-cost drugs, such as GLP-1s and auto-immune medications, were two of several elements in this trend.
    • “Researchers also highlighted increased benefits utilization post-pandemic, especially for mental health and substance abuse services.” 
  • Per Medscape,
    • “We may not be as sexy anymore, but we’re cheaper.” The phrase, coined by Ricardo Cohen, president of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), was repeated several times at the organization’s 2025 World Congress in Santiago, Chile. It encapsulates a growing consensus among experts who perform, research, and advocate for metabolic and bariatric surgery amid the surge in use of GLP-1 agonists and related anti-obesity medications.
    • “Surgical approaches may no longer be as fashionable as pharmacologic treatments for obesity, but they remain more economical and cost-effective, according to David Cummings, MD, professor of medicine in the Division of Metabolism, Endocrinology, and Nutrition at the University of Washington in Seattle. Cummings, who studies the hormonal and metabolic mechanisms underlying the effects of metabolic and bariatric surgery on diabetes and body weight, noted that while GLP-1 receptor agonists are “great” and represent the fastest-growing drug class in medical history, “the problem is they are high cost.”
    • “In the US, semaglutide and tirzepatide cost roughly US$900-US$1350 per month compared with US $17,000-$26,000 for a one-time metabolic surgery. Using one of these drugs for less than 2 years, he said, equals the cost of a Roux-en-Y gastric bypass, “which for most people will solve the problem for the rest of their lives.
  • Per MedPage Today,
    • “Home automatic external defibrillators (AEDs) modestly improve survival in shockable cardiac arrests but are not currently cost-effective.
    • “Equipping all private homes with AEDs would cost over $4 million per quality-adjusted life-year.
    • “Future innovations — cheaper devices and AI-driven risk prediction — could make home AED use feasible.”
  • JAMA Network tells us,
    • “The COVID-19 pandemic placed significant strain on the US health care workforce. Physicians experienced a sudden change to usual practice activities with practice interruptions peaking in April 2020. In 2021, self-reported rates of burnout and intent to leave medicine among physicians spiked. Studies using Medicare fee-for-service (FFS) claims data found no increase in physician turnover in 2020 but did find evidence of age-adjusted physician exits from Medicare during the COVID-19 pandemic.
  • Fierce Pharma informs us,
    • “Turning 18 in the U.S. marks the beginning of legal adulthood, traditionally bringing with it major changes, such as the start of college or a career and, for many, the need to switch from pediatric to adult healthcare.
    • “Particularly concerned about the latter leap is Ipsen, which on Thursday unveiled a new educational initiative dedicated to supporting teenagers and young adults in the transition from their pediatricians to adult care, for which they’re often unprepared.
    • “The “Healthcare Shift” website—unbranded, save for the Ipsen logo at the bottom—encourages young people to “become the CEO of your health” and offers tools and tips for doing so, personalized for those as young as 10 years old and up to 26, marking the point when individuals are no longer allowed to be on their parent or guardian’s insurance plan.”