Tuesday report

Obesity

Tuesday report

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

From Washington, DC,

  • The Hill reports,
    • “President Trump on Tuesday said he would prefer not to extend Affordable Care Act subsidies that are set to expire at the end of the year, but he acknowledged it may be necessary to reach an agreement on health care legislation.
    • “Trump, in response to a question from The Hill, told reporters his preference was to pass legislation that gave money directly to Americans to allow them to purchase their own health care plan.
    • “I like my plan the best. Don’t give any money to the insurance companies, give it to the people directly. Let them buy their own health care plan. And we’re looking at that. If that can work. We’re looking at that,” Trump said.
    • “Asked if he is planning to extend the Affordable Care Act subsidies that were at the heart of the government shutdown debate, Trump said he’d “rather not.”
    • “Somebody said I want to extend them for two years. I don’t want to extend them for two years. I’d rather not extend them at all,” Trump said. “Some kind of extension may be necessary to get something else done, because the un-Affordable Care Act has been a disaster.”
    • “Trump told reporters he was talking with Democrats about health care, but when asked who specifically, he would not say.”
  • Roll Call adds,
    • “The front-runner to be the next top Republican on the House Budget Committee is eyeing a potential second reconciliation bill that could include tax and health care provisions that were dropped from the GOP’s “big, beautiful” package last summer.
    • “Rep. Lloyd K. Smucker, R-Pa., the first entrant and heavy favorite in the race to succeed retiring Budget Chairman Jodey C. Arrington, R-Texas, said he would like to see an extension of the Work Opportunity Tax Credit as part of a future reconciliation bill.
    • “That credit goes to employers who hire individuals from groups that face barriers to employment, such as veterans, ex-felons and recipients of Supplemental Nutrition Assistance Program benefits, among others. The credit is set to expire at the end of this year.
    • “I think there were a number of pieces of tax policy that were not included in the bill that we did, and I’d love to see some of those provisions passed,” he said.
    • “Speaker Mike Johnson, R-La., has pushed to do a second — and even a third — reconciliation package before the midterm elections, although the contours of a follow-up bill are still far from clear. But President Donald Trump has said he believes the reconciliation law that he signed in July is sufficient and that additional legislation is not necessary.”
  • The Wall Street Journal relates,
    • “The U.S. government negotiated lower prices in the federal Medicare program for 15 high-selling medicines including Ozempic, widening an effort to rein in drug costs.
    • “The new prices, which will take effect in 2027, shave 38% to 85% off the list prices for drugs for diseases including asthma, cancer and diabetes. The reductions are estimated to save Medicare, the health-insurance program for the elderly, $12 billion.
    • “For some patients, the lower prices could reduce spending on copays or other out-of-pocket charges imposed by their particular plan. Other patients taking the drugs might not see a direct savings, however, because they have fixed monthly copays. 
    • “Also, Medicare members now have a $2,000 annual cap on out-of-pocket drug costs. Yet the savings could help curb growth in plan premiums.
    • “In addition to Ozempic, other drugs that will cost Medicare less thanks to the negotiations include GSK’s Trelegy asthma treatment, Pfizer’s breast-cancer therapy Ibrance and Merck diabetes pill Janumet—all of them huge sellers.
    • “The price cuts apply to Medicare, not to private health-insurance plans. Medicare spends more than $150 billion a year on prescription drugs, and the cuts will mean reduced revenue for drugmakers. Yet some companies say the impact will be modest. 
    • “Some of the muted effect is because drugmakers already provide rebates and discounts to Medicare drug-benefit plans on many drugs. So, the negotiated prices aren’t as much of a discount off net prices as they are from list prices.”
  • Here’s a link to the CMS news release about the 2027 Medicare drug price negotiations.
  • Bloomberg adds,
    • “The Trump administration on Tuesday proposed a rule cementing changes to patient cost-sharing in Medicare’s Part D prescription drug benefit and updating the methodology used to rate private Medicare Advantage plans.
    • “If finalized, the rule, RIN 0938-AV63, would implement changes to Part D that Congress enacted as part of the Inflation Reduction Act under President Joe Biden, and update the methodology used to award insurers quality “star ratings” that determine bonuses and marketing privileges. The changes would take effect in 2027.” * * *
    • “The CMS also proposed eliminating star ratings measures that it said were based on “administrative processes” and not indicative of a plan’s quality. The agency is also proposing to forgo a change related to enrollees with social risk factors, and to add new measures focused on treating depression.
    • “The proposal would also allow Medicare Advantage members a special enrollment period when their doctor leaves their network.”
  • Here’s a link to the CMS fact sheet on this proposed rule.
  • Healthcare Dive offers a good summary of the Medicare changes found in the outpatient facility pricing final rule released last Friday. For example,
    • “Hospital outpatient departments currently receive higher reimbursement for providing the same services compared with freestanding physician offices and ambulatory surgery centers — a policy critics say drives up costs for patients and Medicare. 
    • “In the latest payment rule, the CMS finalized a regulation that would reimburse off-campus outpatient departments owned by hospitals at the same rates as physician offices for drug administration services. 
    • “That change should cut outpatient spending by $290 million in 2026, with $220 million of the savings going to Medicare and $70 accruing to beneficiaries, according to the CMS. 
    • “Additionally, the agency is moving to phase out the inpatient only list, a list of which surgical procedures have to be furnished in hospitals, over three years. The CMS will start with removing 285 mostly musculoskeletal procedures next year.
    • “The American Hospital Association lambasted the site-neutral policy changes, arguing they ignore the differences between care delivery at hospital outpatient departments and other care sites.” 
  • The Wall Street Journal reports,
    • “The Centers for Disease Control and Prevention appointed Louisiana surgeon general Dr. Ralph Abraham as the second in command, the latest move in a year of upheaval for the agency.
    • “Abraham, a vaccine skeptic, has been named the deputy principal director of the CDC. The agency has shuffled through multiple leaders since Health Secretary Robert F. Kennedy Jr., also a vaccine skeptic, began overseeing the CDC earlier this year.
    • “Kennedy’s views on vaccines have caused turmoil at the agency. Susan Monarez, the former CDC director, said she was ousted after refusing to approve all future recommendations from a vaccine advisory panel filled with Kennedy’s appointees and refusing to fire CDC vaccine-policy officials. Jim O’Neill, Kennedy’s deputy, is currently serving as the CDC’s acting director.
    • ‘Most recently, a CDC webpage that previously said vaccines don’t cause autism now says they might—an assertion former CDC employees and doctors outside the agency have fervently disagreed with.
    • “Abraham was appointed the Louisiana surgeon general last year and later criticized government vaccine mandates. He condemned Covid-19 vaccine mandates earlier this year as “an offense against personal autonomy that will take years to overcome.” * * *
    • “The family-medicine doctor and veterinarian also represented Louisiana in Congress from 2015 to 2021.”
  • Tammy Flanagan, writing in Govexec, opens her Mailbag: Retirement applications and processing/ A look at common retirement-processing snags, what causes delays and where OPM’s newer systems fit into the picture.”

From the Food and Drug Administration front,

  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil Speed Control Dials used with the SmartDrive MX2+ Power Assist Device for wheelchairs after identifying a design issue that can lead to unexpected behavior of the SmartDrive motor. The FDA said Max Mobility/Permobil reported two serious injuries associated with the issue.
    • “In addition, the FDA issued an early alert for certain Fresenius Kabi Ivenix LVP Primary Administration Sets due to an assembly defect.”
  • Per Fierce Pharma,
    • “AstraZeneca’s Imfinzi is adding yet another landmark perioperative label to its belt with a new FDA approval that gives the drug the title of the first and only immunotherapy marketed to treat early-stage stomach cancer patients both before and after surgery.
    • “With the nod, Imfinzi can be added to standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) to treat adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. The approval specifically allows Imfinzi to be used with chemotherapy before surgery, then after surgery with chemotherapy and eventually on its own as a monotherapy.”
  • and
    • “When the FDA reworked the prescribing information for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys earlier this month, the company touted a plan to study a regimen designed to reduce liver-associated risks and potentially reach patients left off of the drug’s new label. Now, with the FDA’s go-ahead, the company is commencing with that effort.
    • “The FDA gave Sarepta the green light to use an “enhanced immunosuppressive regimen” in the planned Cohort 8 of its Endeavor study, the company announced in a Tuesday press release. The regimen, which features the administration of sirolimus prior to and after the Elevidys infusion, will be studied in non-ambulatory individuals with DMD or those who can no longer walk independently.”
  • MedTech Dive relates,
    • “Ceribell has received 510(k) clearance to use its Clarity seizure-detection algorithm in neonates, the company said Monday.
    • “The algorithm processes data captured by a headcap with electroencephalography sensors to detect electrographic seizures. Subclinical seizures can go undetected without EEG monitoring.
    • “Ceribell executives have estimated that the neonatal and pediatric markets will add $400 million to its current $2 billion addressable market opportunity.” 
  • STAT News points out,
    • “The Food and Drug Administration on Tuesday approved the first drug from an emerging class of medicines for patients with chronic, autoimmune kidney disease, according to a notice on the agency’s website.
    • “The new drug, called Voyxact, is made by Otsuka, the Japanese pharmaceutical company. U.S. regulators cleared it to treat IgA nephropathy, or IgAN, a disease caused by the build-up of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.”

From the judicial front,

  • Healthcare Dive reports,
    • “The Trump administration will continue to fight in court over a Biden-era regulation that would audit Medicare Advantage plans and claw back billions of dollars in overpayments.
    • “In a Friday filing, the federal government said it would appeal a judge’s decision from September that vacated the Medicare Risk Adjustment Data Validation, or RADV, rule for violating the Administrative Procedures Act.
    • “The move to take the case to the Fifth Circuit Court of Appeals comes as regulators have said they’ll crack down on MA overpayments, including through a plan this spring to increase audits.”
  • Per Fierce Healthcare,
    • “Humana will appeal a court loss over the Medicare Advantage star ratings, according to a filing issued Tuesday.
    • “The insurer filed a notice that it will appeal the District Court ruling to the Fifth Circuit Court of Appeals. The filing doesn’t offer further details on the grounds to appeal.
    • “Humana first filed suit to challenge the star ratings methodology in October 2024 after the number of people enrolled in plans with four or more stars dropped from 94% in 2024 to 25% in 2025. In the most recent round of scores, the number of enrollees in plans with at least four stars decreased further to 20% for 2026.
    • “In the lawsuit, Humana argues that the Centers for Medicare & Medicaid Services determined that three test phone calls were poor, which drove the score drop.
    • “Texas Judge Reed O’Connor tossed the case in mid-October, saying that these determinations were not “arbitrary and capricious” and instead complied with federal law.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A new study found people with untreated obstructive sleep apnea could have an increased risk of developing Parkinson’s disease.
    • “Researchers studied medical records for more than 11 million military veterans between 1999 and 2022 and found those with obstructive sleep apnea had a higher chance of developing Parkinson’s disease compared with those without the disorder, according to the study published in JAMA Neurology on Monday. 
    • “It’s not at all a guarantee that you’re going to get Parkinson’s, but it significantly increases the chances,” said Dr. Gregory Scott, a co-author of the study and assistant professor at the Oregon Health & Science University School of Medicine, or OHSU.”
  • A commentator in STAT News tells us,
    • “For years, federal policymakers have tweaked lung cancer screening guidelines as if the barrier to saving lives is a math problem. Add a few years to the eligibility age. Drop a few pack-years — a measure combining how much and how long someone has smoked. Remove a quit-time rule. Repeat.
    • “But it was never really a math problem. A new study in JAMA Network Open makes clear what many of us in cancer prevention and control have been warning for over a decade: No amount of technical adjusting will fix a system built on stigma.
    • “I see the effects of this every day. As a behavioral scientist and nurse practitioner, I’ve sat with hundreds of patients confronting the potential of a lung cancer diagnosis. I’ve watched people brace themselves before they say the words “I used to smoke,” even when they quit decades ago. I have watched people who have never smoked rush to explain why they got lung cancer at all.
    • “These reactions aren’t personal quirks. They are predictable responses to a system that has taught people to expect judgment.”
    • “That system is failing on its own terms. The new study examined nearly 1,000 people diagnosed with lung cancer at a major academic medical center and found that 65% would not have qualified for screening under today’s U.S. Preventive Services Task Force (USPSTF) criteria.” * * *
    • “The population ineligible for screening is not random. It is disproportionately women, Asian Americans, and people who have never smoked. These are groups the current framework structurally misclassifies as “lower risk,” despite real-world evidence to the contrary.
    • “Only one approach captures nearly all of them: age-based screening. The test itself is straightforward: a low-dose CT scan that takes about 10 minutes and exposes patients to minimal radiation. Screen everyone ages 40 to 85, regardless of smoking history, and you detect 94% of cancers and prevent more than 26,000 deaths every year.  The cost is lower than what we routinely pay for breast or colorectal cancer screening. The number needed to screen to prevent one lung cancer death is 320. For comparison, mammography requires screening about 1,339 women to prevent one breast cancer death, and colonoscopy requires screening about 455 people to prevent one colorectal cancer death. Yes, broader screening means more false positives and follow-up imaging, but these trade-offs are manageable — and far less burdensome than the status quo, which misses two-thirds of cases entirely.”MedP
  • MedPage Today lets us know,
    • “Guidelines recommend a single dose of RSV vaccine for older adults, but long-term data on the duration of protection is limited.
    • “In this study of U.S. veterans, effectiveness slid from over 80% in the month following vaccination to about 60% through 18 months. Among the immunocompromised individuals, vaccine effectiveness fell from 75% to 40%.
    • “The potential benefits and risks of a second vaccine dose in certain groups should be examined,” according to the authors.”
  • The New York Times reports,
    • “Danish researchers were examining the use of medications during and after pregnancy when they noticed a clear trend: The number of women using weight-loss drugs like Ozempic and Wegovy soon after childbirth had risen sharply.
    • ‘In 2018, few women were using the drugs during the first six months after having a baby, with fewer than five prescriptions for every 10,000 new mothers. By mid-2022, that figure had increased to 34 prescriptions for every 10,000 new mothers, and by mid-2024, it had jumped to 173 prescriptions for every 10,000, or almost 2 percent of postpartum mothers. Most of the women were over 30, and two-thirds had more than one child. A majority were overweight, but they did not have diabetes, and they had no history of using the drugs, known as GLP-1s, the researchers wrote.
    • “In a period characterized by natural weight loss and marked hormonal change, this was unexpected,” said Mette Bliddal, a pharmacologist and researcher at University of Southern Denmark in Odense, Denmark, and the paper’s first author.
    • “The new study was published online on Monday in JAMA Network Open.” * * *
    • “Although semaglutide, the active ingredient in Wegovy and Ozempic, aids in weight loss, little is known about the drug’s effects after childbirth, when new mothers are experiencing hormonal changes.
    • “The American College of Obstetricians and Gynecologists has not issued a guidance about the use of weight-loss drugs postpartum because the drugs are so new and the data is insufficient. But First Exposure, a digital information hub and research network at the University of Toronto that provides evidence-based information about drug safety during pregnancy, recommends that patients avoid taking the drugs while breastfeeding. (First Exposure also recommends not taking the medications during pregnancy and stopping them a month or two before a planned pregnancy).”

From the U.S. healthcare business and artificial intelligence front,

  • The American Hospital Association News notes,
    • “The Trump administration issued an executive order Nov. 24 launching the Genesis Mission, an artificial intelligence initiative focusing on scientific research. The program will focus on efforts related to national, economic and health security, among other areas. The order adds to other White House actions in recent months regarding AI innovation and infrastructure to support health care and other sectors.”
  • Bloomberg points out,
    • “Thousands of health providers that treat lower-income and uninsured patients are scrambling to adjust to a new program to access steeply discounted medicines from drugmakers that stands to overhaul their operations and finances.
    • “The 340B Rebate Model Pilot Program, administered by the US Health Resources & Services Administration, is set to significantly change how the 340B Drug Pricing Program operates after the Trump administration approved rebate models from pharmaceutical companies such as Bristol Myers Squibb Co., Johnson & Johnson, and Novo Nordisk A/S.
    • “Drugmakers under the federal program currently provide up-front drug discounts to covered safety-net hospitals, clinics, and health centers that treat a disproportionate number of low-income and uninsured patients. But under the pilot, covered providers, starting on Jan. 1, 2026, will buy certain medicines at full price and then submit data to drugmakers to receive a rebate.
    • “Health providers are now preparing for the pilot—grappling with nine unique drugmaker models, weighing operational changes, and analyzing the financial risks with purchasing drugs at commercial prices.”
  • Per Beckers Payer Issues,
    • “UnitedHealth Group has purchased a four-story, 79,000 square foot medical office building in Henderson, Nevada.
    • “The $46.1 million building houses Optum Nevada’s new Cactus Healthcare Center and marks the largest medical office transaction in the Las Vegas market this year, according to real estate firm Colliers.
    • “UnitedHealth purchased the building through its Sierra Health and Life Insurance subsidiary in October, the Las Vegas Review-Journal reported.”
  • Fierce Healthcare informs us,
    • “Capital Rx has unveiled Capital Equilibrium, a new level-funding pharmacy benefit management offering.
    • “The program leans on an A-rated stop-loss carrier for reinsurance as well as Capital Rx’s PBM services to provide a fixed monthly payment plan that covers anticipated claims, administrative costs and stop-loss. The pricing is often below market rates, according to the announcement.
    • “The stop-loss insurance manages claims that exceed monthly limits, while the PBM piece is built on a “fair” pricing structure that eschews traditional discounts and rebates, Capital Rx said.
    • ‘Plan sponsors in all 50 states can sign on with Capital Equilibrium, according to the announcement.”
  • Genetic Engineering and Biotechnology News identifies the “Top 20 Drugs Heading for the Patent Cliff, 2026-2029. Last year, these treatments accounted for 75% of the $236B in annual sales set to vanish with the loss of exclusivity.”
  • McKinsey & Co. delves into the five dimensions of the wellness economy.
  • Per BioPharma Dive,
    • “Gilead Sciences is looking at a new way to attack cancer, buying into a preclinical program from the Swedish biotech Sprint Bioscience.
    • “The deal announced Monday centers on a target known as TREX1. Research suggests a healthy TREX1 gene can help prevent overactivation of the immune system that leads to conditions such as lupus, but it may also help cancer cells hide from the body’s natural attackers. In oncology, researchers are trying to inhibit TREX1 to unleash anti-tumor immune activity.
    • “TREX1 has demonstrated significant potential in the preclinical phase,” Sprint Bioscience CEO Johan Emilsson said in a statement. The new agreement calls for Gilead to pay Sprint $14 million up front and as much as $400 million more if the program meets certain clinical, regulatory and commercial milestones.”

Weekend update

David Ermer–CDC, Congress, Federal employment benefits, Generative AI, Obesity, U.S. Healthcare–

From Washington, DC,

  • Congress is out of session this week for the Thanksgiving holiday.
  • Modern Healthcare reports,
    • “President Donald Trump said he hopes to secure a solution by Jan. 30 for an impending surge in health insurance premiums for millions of Americans, the first timeline he has publicly offered for what he has pitched as an alternative to the Affordable Care Act.
    • “Trump said in an interview with Fox News Radio Friday that Republican senators Rick Scott of Florida and Katie Britt of Alabama are working on the proposal.
    • “We have a Jan. 30 day coming up, I’d like to see if we could do it by then,” Trump said. “They say, ‘well, let’s go another year.’ And I said, ‘let’s see if we can get it done by Jan. 30.’”
  • Federal News Network tells us,
    • “Last week’s conclusion of the record-breaking government shutdown was great news for federal employees in general. But for a few thousand specific feds, it was even better news. They’d been told they were about to lose their jobs completely, and as of Friday, [November 21, 2025] almost all of them have now had those notices formally rescinded.
    • “Filings the Justice Department submitted to a federal court in San Francisco on Friday indicate that each of the more than 3,000 federal workers who had received reduction in force (RIF) notices after the shutdown began have now been formally notified that those RIFs have been cancelled.
    • “That action came as a result of several provisions in the continuing resolution Congress passed last week to reopen the government. The legislation provided that not only any RIF notice an agency issued on Oct. 1 or later “shall have no force or effect,” but it also barred federal agencies from using any funding to conduct any further RIFs for as long as the current CR is in effect.”
  • Healthcare Dive informs us,
    • “Oracle Health has received Qualified Health Information Network status under the federal government’s health data sharing framework, the technology giant said Thursday. 
    • “The designation allows the Oracle Health Information Network to transfer health information between providers, payers and government agencies through the Trusted Exchange Framework and Common Agreement, or TEFCA. The HHS created the framework to facilitate the exchange of health records.
    • “Eleven data exchanges have now received QHIN status, more than double the number that were recognized when TEFCA went live at the end of 2023.” 
  • There are sixteen days left in the Federal Benefits Open Season.

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “A Washington [State] resident who was the first human case of bird flu in the U.S. since February died on Friday, state health officials said. The person was an older adult with underlying conditions and had been hospitalized since early November with a strain that was previously reported in animals but never before in humans.
    • “The person had been undergoing treatment for infection with H5N5 avian influenza, the health department said in a news release. State epidemiologist Scott Lindquist said last week that the person, who was hospitalized after developing high fever, confusion and respiratory distress, was “a severely ill patient.”
    • “State officials said the risk to the public remains low. No other people involved have tested positive for influenza, and public health officials are continuing to monitor anyone who was in contact with the patient — including more than 100 health care workers — for symptoms to ensure that human-to-human spread has not occurred, the health department said.
    • “That strain of the avian influenza virus, H5N5, had previously been reported in animals but not in humans. It is part of the family of avian influenza viruses and has been seen in wild birds in other U.S. states and Canada, state officials and experts have said.”
  • The Wall Street Journal examines “why autoimmune diseases rise sharply after 50. Scientists are making progress in understanding and treating these disorders, which can go unrecognized for years.”
    • “While there is no sure way to prevent autoimmune disease, research suggests that keeping chronic inflammation in check—through a healthy diet, regular exercise, good sleep, stress control, and maintaining a healthy weight—can help support a calmer, more balanced immune system. By contrast, unproven supplements or treatments that claim to boost the immune system could do more harm than good.”
  • Per MedPage Today,
    • “Rates of pertussis, also known as whooping cough, are surging in Texas, Florida, California, Oregon, and other states and localities across the country.
    • “The outbreaks are fueled by falling vaccination rates, fading immunity, and delays in public health tracking systems, according to interviews with state and federal health officials. Babies too young to be fully vaccinated are most at risk.
    • “Pertussis cases increase in a cyclical fashion driven by waning immunity, but the size of the outbreak and the potential for severe outcomes in children who cannot be vaccinated can be mitigated by high coverage and good communication to folks at risk,” said Demetre Daskalakis, MD, MPH, a former head of the CDC’s immunization program, who resigned in August.”
  • NPR Shots lets us know,
    • Millions of Americans have shed pounds with help from drugs like Wegovy and Zepbound.
    • But people who take these drugs often experience unpleasant side effects.
    • “They lose weight, which is a positive thing,” says Warren Yacawych of the University of Michigan, “but they experience such severe nausea and vomiting that patients stop treatment.”
    • “So, at this year’s Society for Neuroscience meeting in San Diego, Yacawych and other researchers held a session to describe their efforts to understand and solve the side-effect problem.”
    • The article discusses the expert presentation.
  • Medscape adds,
    • “The surge of demand for GLP-1s is likely very common in your practice, and during your follow-up discussions with patients, they may often share their progress on the medication. But some patients may share that they are not hitting weight-loss markers they thought they would. Some may even compare the rate of their weight loss to that of others they know.
    • As a primary care doctor, responding to this rhetoric is part of your role. [The article offers] some thoughts about messaging and directives to offer patients to get these conversations started and how to respond to feedback.
  • and
    • A first-in-human study suggested that tirzepatide — a dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist — modulated abnormal activity in the brain’s nucleus accumbens, thereby reducing food cravings and inducing weight loss in a patient with severe obesity.

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Pharma reports,
    • “Maryland is becoming the home away from home for British drugmaker AstraZeneca. On Friday, the biopharma powerhouse upped its ante in the Old Line State, saying it will invest $2 billion to increase its manufacturing presence there.
    • “The funding will allow AZ to nearly double the production capacity at its flagship biologics plant in Frederick, Maryland, and also provide for the manufacture of the company’s rare disease products there for the first time, AZ said.
    • “The company will also establish a clinical manufacturing site in Gaithersburg, Maryland. The facility, which was acquired last month in a $60 million lease transfer, is the former headquarters of vaccine specialist Novavax and will host the production of molecules for medical trials, AZ added.
    • “The outlay will create 200 additional jobs at the Frederick site and 100 more at the new Gaithersburg facility, which is 25 miles to the southeast.”
  • and
    • “A Novo Nordisk challenge has driven a Pennsylvania-based telehealth company to voluntarily discontinue compounded semaglutide product claims, adding to the Danish drugmaker’s string of wins against companies selling copycat versions of its GLP-1 blockbuster.
    • “Novo challenged claims made by Regen Doctors via BBB National Programs’ National Advertising Division (NAD). The challenge centered on express and implied claims about the superiority, safety, efficacy and health benefits of Regen’s compounded semaglutide product. Novo sells the GLP-1 receptor agonist semaglutide under the brand names Ozempic and Wegovy.
    • “After the NAD began looking into the challenge, Regen told the self-regulatory body that it had permanently discontinued the claims, according to an NAD report Thursday. Regen’s actions prompted the NAD to stop reviewing the claims, and the watchdog said it will treat the discontinued claims as if it recommended that Regen stopped making the statements.
    • “The case is part of a series of challenges Novo has recently brought against semaglutide compounders via the NAD. Since June, Bayview Pharmacy, Medicine Center Pharmacyand Fletcher Family Medical Center have all voluntarily discontinued claims about compounded semaglutide. The NAD reported the conclusion of the Fletcher case one week before sharing details of Regen’s decision to discontinue its claims.”
  • Fierce Healthcare provides a look at how UnitedHealthcare is developing, deploying AI solutions.
  • HR Dive informs us,
    • “Despite increasing adoption of artificial intelligence tools at work, many U.S. employees remain uneasy about how AI may shape the future of work — and the companies that use it, according to a Monday report from SHL, a talent insight firm.
    • “Notably, 74% of workers said being interviewed by an AI agent would change their perception of the company, with 37% saying it’s “impersonal” and 23% saying it’s “innovative.” Although most workers said they’re open to interacting with an AI interviewer, they still want human involvement and accountability in the process, the report found.” * * *
    • “By 2026, 1 in 3 companies say AI will run their hiring process, according to a report from Resume.org. More than half already use AI in hiring, yet a similar amount also expressed concerns about AI screening out qualified candidates, introducing bias or lacking human oversight.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “A bipartisan group of House lawmakers released text of legislation Friday aimed at avoiding the health care subsidy cliff by extending Affordable Care Act tax credits for two years while installing income caps and anti-fraud measures.
    • “Reps. Tom Suozzi, D-N.Y., Don Bacon, R-Neb., Josh Gottheimer, D-N.J., and Jeff Hurd, R-Colo., see the measure as a viable compromise that includes Democrats’ demand for a subsidy extension alongside protections sought by many Republicans. It would also significantly lengthen the open enrollment window, which would allow more people into plans, thus strengthening risk pools and lowering premiums.
    • “The text arrives as much of Congress is divided on how to approach the possible end to enhanced premium tax credits under the 2010 health care law, which expire Dec. 31. Many Republicans see any extension as propping up the ACA and won’t support such a move. Without a solution, prices for insurance through state exchanges or healthcare.gov could force people to quit the coverage.” * * *
    • “A bill from Reps. Sam Liccardo, D-Calif., and Kevin Kiley, R-Calif., that also features a two-year extension largely follows a similar framework.
    • “Unlike the Liccardo-Kiley bill, however, this legislation does not include language that would limit excessive payments to Medicare Advantage, a practice known as upcoding. The Liccardo-Kiley bill incorporated the Medicare Advantage language as an offset to pay for the tax credit extension.”
  • and
    • “At least one of the Senate’s yet-to-be-unveiled fiscal 2026 appropriations bills could be released next week, even though lawmakers will be in their districts for the Thanksgiving recess.
    • “There is a good chance the Senate will post its version of the Energy-Water bill, one of the four the Senate has not yet released, House Appropriations Chair Tom Cole, R-Okla., said Friday.
    • “The issue was discussed when the top four House and Senate appropriators met Thursday, Cole said. “I don’t know about the other three, but we raised a lot of questions about Energy and Water, since we’ve actually passed that one across the [House] floor,” he said.
    • “Senate appropriators are aiming to release that bill and potentially more of the outstanding bills — Financial Services, Homeland Security and State-Foreign Operations — next week, a source familiar with the plan said. But that plan is not final, the source said.
    • “House Appropriations ranking member Rosa DeLauro, D-Conn., said Friday that the lawmakers discussed the outstanding Senate bills and that Senate Appropriations Chair Susan Collins, R-Maine, said the text could be posted early next week.”
  • Mercer consulting offers an overview of the current healthcare care policy debate in Congress.
  • OPM Director Scott Kupor posted a new Secrets of OPM blog entry, this time about ongoing Administration efforts to right size the federal workforce.
  • Per an HHS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is improving the quality of care for Medicare beneficiaries while significantly reducing unnecessary spending and improving choices and hospital price transparency for Medicare beneficiaries. The calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule (CMS-1834-FC) advances a series of patient-focused reforms that will modernize payments, expand access to care, enhance hospital accountability, and safeguard the Medicare Trust Funds from fraud, waste, and abuse.
    • “This final rule from CMS closes the loopholes hospitals exploit to hide real prices and advances President Trump’s demand for radical hospital price transparency,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are also confronting addiction head-on by expanding access to non-opioid treatments and implementing common-sense payment policies that make care more affordable and accessible for seniors.”
    • “We are strengthening Medicare’s foundation by protecting beneficiaries, eliminating fraud, and advancing medical innovation —all while maintaining strict provider accountability and responsible use of taxpayer funds,” said CMS Administrator Dr. Mehmet Oz. “These comprehensive reforms expand patient choice and establish the price transparency Americans need for confident healthcare decisions.” * * *
    • “The final rule can be viewed at the Federal Register at: www.federalregister.gov/public-inspection/.
    • “View the fact sheet on the final rule at: www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-ambulatory-surgical-center.
    • “For a fact sheet on the hospital price transparency policy changes in the final rule, visit: www.cms.gov/newsroom/fact-sheets/cy-2026-opps-ambulatory-surgical-center-final-rule-hospital-price-transparency-policy-changes.”
  • The American Hospital Association adds,
    • “The Centers for Medicare & Medicaid Services released an updated notice Nov. 20 on the processing of Medicare provider claims impacted by the government shutdown. The agency said it instructed Medicare Administrative Contractors to conduct mass adjustments to any paid claims that are inconsistent with the government funding legislation, which retroactively restored many payment provisions through Jan. 30. This includes a payment adjustment for low-volume inpatient hospitals and one for the Medicare-dependent Hospital program. In addition, CMS said that hospitals can resubmit returned claims for telehealth services and the Acute Hospital Care at Home program dated Oct. 1 or later.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “Hexoskin, a Canadian medtech company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new “smart shirt” capable of long-term heart and respiratory monitoring. 
    • “The Hexoskin Medical System was designed to deliver continuous evaluations of a person’s real-time electrocardiogram (ECG) and respiratory health. Signals are then evaluated through the company’s data management platform.
    • “According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as medical researchers. The device is now approved for use during clinical trials performed in the United States, for example, delivering ECG, heart rate, respiratory rate and other activity data that can research teams can track for extended periods of time.
    • “Hexoskin has also made it a priority to use advanced artificial intelligence algorithms to seek out new digital biomarkers that work “beyond traditional cardiopulmonary monitoring.” 
  • Fierce Pharma adds,
    • “As the researchers behind Pfizer and Astellas’ Padcev and Merck’s Keytruda have taken victory laps on the heels of the positive readout of Keynote-905 study—also known as EV-303—terms like “transformational,” “practice-changing” and “new standard of care” have been put to use.
    • “With an FDA approval on Friday, the combination now has its official go-ahead as a perioperative treatment regimen for people with muscle-invasive bladder cancer (MIBC) who can’t receive chemotherapy.
    • ‘Padcev and Keytruda is the first and only approved perioperative treatment regimen for cisplatin-ineligible patients with MIBC, Pfizer said in a media statement Friday, meaning the pairing can be used before and after surgery.
  • and
    • “The FDA has opened an investigation into Takeda’s recombinant protein med Adzynma following the reported death of a pediatric patient who received the drug.
    • “The probe comes as the regulator says it has received multiple postmarketing reports of patients developing neutralizing antibodies to ADAMTS13, the enzyme-creating gene that underpins Takeda’s drug. The single reported patient death “appears to be related to Adzynma,” the FDA said in a Nov. 21 safety communication.
    • “Takeda’s medicine was approved in November of 2023 as the first recombinant protein product for use as a preventive or on-demand enzyme replacement therapy in adults and children with the rare genetic blood-clotting disorder, congenital thrombotic thrombocytopenic purpura (cTTP). The condition is believed to be caused by a disease-triggering mutation in the ADAMTS13 gene, which produces an enzyme responsible for regulating clotting.
    • “The Tokyo-based pharma did not respond to Fierce Pharma’s request for comment on the situation by publishing time.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced Friday,
    • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old. Seasonal influenza activity remains low nationally but is increasing. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.’ * * *
    • “Season Outlook
      • “CDC expects the upcoming fall and winter respiratory disease season in the United States will likely have a similar number of combined peak hospitalizations due to COVID-19, influenza, and RSV compared to last season. CDC will update this outlook every two months throughout the season and as warranted by changes in the trajectories of any of the three diseases. Read more: 2025-2026 Respiratory Disease Season Outlook“
  • Beckers Clinical Leadership adds,
    • “Some hospitals are reporting an uptick in respiratory syncytial virus hospitalizations in recent days, though national data — delayed by the federal shutdown — has yet to offer a clear picture.
    • “Cincinnati Children’s Hospital reported an early uptick in admissions this fall, according to Hamilton County Public Health Medical Director Steve Feagins, MD.
    • “Last year, we saw it early. This year, we saw it even earlier, resulting in, like, September beginning to get some admissions and hospitalizations at Cincinnati Children’s,” he told CBS affiliate WKRC.
    • “The county reported 32 admissions in the week ending Nov. 15, up from 28 a week prior, state data shows.” 
  • The University of Minnesota CIDRAP relates,
    • “Over 40% of nearly 8,600 US adults who had advanced hepatitis B–related liver disease appear to have received no treatment for their infection, a gap especially apparent in women and Black or White patients, according to findings published yesterday in JAMA Network Open.
    • “A team led by a Stanford University researcher and including scientists from hepatitis B virus (HBV) drug maker and study funder Gilead Sciences evaluated the HBV treatment status of 8,594 infected patients included in an electronic health record data network from April 2016 to December 2022. The study focused on patients who met American Association for the Study of Liver Diseases 2016 and 2018 qualification criteria for HBV treatment.
    • “Treatment of hepatitis B virus (HBV) infection reduces the risk of disease progression and negative outcomes such as hepatic decompensation and hepatocellular carcinoma (HCC),” the researchers wrote. “Studies from select populations in the US suggest that treatment levels are low; whether this pattern occurs nationally remains unclear.” * * *
    • In a commentary in the same journal, Amir Mohareb, MD, of Massachusetts General Hospital, and Arthur Kim, MD, of Harvard Medical School, noted that the risk of perinatal HBV transmission from mother to child is very low in the United States due to the availability of HBV immunoglobulin and the HBV vaccine birth dose. 
    • “But “there is cause for concern that this policy may change, as newly appointed members of the Advisory Committee on Immunization Practices in 2025 debate removing the recommendation for birth-dose HBV vaccination in the US,” they wrote.
    • “Removing the recommendation for universal birth-dose vaccination would be a major step backward for elimination of HBV and would be potentially in direct contradiction to the Department of Health and Human Services Viral Hepatitis National Strategic Plan for the US,” they added”
  • Beckers Hospital Review tells us,
    • “The overall U.S. healthcare system received a “C” grade from a broad survey of U.S. adults, according to the West Health-Gallup Center for Healthcare in America, which released its inaugural report, “State of the States 2025: Insights on Healthcare in America.”
    • “Nationwide, the healthcare system received a “D+” for cost, a “C+” for quality and a “C+” for access. 
    • “The rankings are based on an online survey of 19,535 U.S. adults conducted June 9 to Aug. 25 across all 50 states and the District of Columbia. Respondents graded the healthcare system in their state, with letter grades converted to a 4.0 GPA scale for analysis.”
  • A medical specialist interviewed in MedPage Today identifies “13 Visible Signs of Heart Disease. What skin, nails, eyes, and more can reveal about cardiovascular disease.”
  • Health Day informs us,
    • “Even occasional or low-intensity smoking significantly increases cardiovascular and mortality risks, according to a study published online Nov. 18 in PLOS Medicine.
    • “Erfan Tasdighi, M.D., from the Johns Hopkins Ciccarone Center for Prevention of Cardiovascular Disease in Baltimore, and colleagues examined the relationships among smoking burden, intensity, and cessation duration across multiple cardiovascular outcomes. The analysis included data from 323,826 adult participants in 22 prospective cohort studies with median follow-up varying from 14.4 to 19.9 years.” * * *
    • “It is remarkable how harmful smoking is — even low doses of smoking confer large cardiovascular risks,” the authors said in a statement. “As far as behavior change, it is imperative to quit smoking as early in life as possible, as the [amount] of time passed since complete cessation from cigarettes is more important [than] prolonged exposure to a lower quantity of cigarettes each day.”
    • “Abstract/Full Text“
  • and
    • “The risk for motor vehicle crashes is increased after a concussion, according to a study published online Nov. 5 in BMJ Open.” * * *
    • “The risk of a motor vehicle crash after a concussion suggests current mitigating efforts are insufficient; however, driving cessation may be unreasonable since the risk also extends to patients as pedestrians,” the authors write. “Instead, clinicians might warn concussion patients to be cautious about prevailing motor vehicle crash risks along with standard anticoncussion campaigns.”
    • “Abstract/Full Text“
  • Healio points out,
    • “Child abuse is linked to long-term risk for negative health outcomes. 
    • “Boys and girls experienced decreases in confirmed maltreatment cases, but girls were subject to greater maltreatment.” * * *
    • “As a preventive measure, we need to address the drivers of maltreatment,” Richard T. Liu, PhD, director of suicide research in the division of child and adolescent psychiatry in the Depression Clinical and Research Program at Massachusetts General Hospital, told Healio. “One prominent driver of maltreatment risk is poverty. Reducing poverty would therefore be important for reducing risk for child maltreatment.”

From the U.S. healthcare business front,

  • This factoid along with more importantly this Brookings Institute report on PBM profitability support the FEHBlog’s view that cracking down on PBMs will not lower healthcare costs. The President’s efforts to lower drug costs could pay dividends.
  • Modern Healthcare adds,
    • “Eli Lilly & Co. and Novo Nordisk A/S plan to start selling their popular obesity shots to employers through a new approach that would bypass traditional drug sales channels in an effort to expand access to the costly weight-loss medicines.
    • “The drugmakers will offer Zepbound and Wegovy to companies starting Jan. 1 through Waltz Health, a firm that helps employers purchase cheaper medications. The shots will be available to employers at upfront, fixed prices, avoiding the rebates and fees that accompany traditional sales through middlemen who manage pharmacy benefits for many companies.” * * *
    • “The offering is aimed at employers that don’t cover obesity drugs right now. About 43% of companies with more than 5,000 workers cover weight-loss drugs, according to a recent survey from KFF. Thierer said four employer clients are signed up to launch the offering in January. Waltz is targeting a goal of making it available to 100,000 people by the end of the first quarter.
    • “The arrangements will only apply to the companies’ weight-loss drugs, not to similar medications intended for diabetes. Waltz will handle screening patients to see if they’re eligible for the drugs, sending prescriptions to pharmacies and supporting patients taking the drugs.
    • “Waltz was recently purchased by a larger firm, Eversana, that works with drug companies to commercialize and distribute their medications. Thierer, a former PBM executive, has said he aims to build an alternative to the “oligopoly” of PBMs and force the industry to change.”
  • Per Yahoo Finance,
    • “CVS Health® (NYSE: CVS) today announced that its Board of Directors has elected President and Chief Executive Officer David Joyner as Chair of the Board, effective January 1, 2026. Following the effective date of this appointment, Michael Mahoney will continue to serve as the Board’s Lead Independent Director, and Roger Farah, who is currently serving as Executive Chair of the Board, will continue to serve on the Board.
    • “Joyner was named President and CEO of CVS Health in October 2024, and has led significant operational, financial and cultural improvements in the Company’s performance over the past year. In recognition of his leadership, nearly 40 years of experience in the health care industry, and the Company’s future growth opportunities, the Board determined Joyner should also serve as Chair of the Board.”
  • Healthcare Dive lets us know,
    • “Western Pennsylvania-based Independence Health System plans to join West Virginia University Health System in the fall of next year, the systems announced Wednesday.
    • ‘Under the proposed merger, which is subject to regulatory reviews and approvals, Independence Health’s five hospitals as well as its affiliated physician groups will operate under WVU Medicine’s brand. 
    • “The systems say the deal will offer operational and financial efficiencies through resource sharing and allow the providers to expand clinical services and access to specialty care.”
  • Per MedTech Dive
    • “Solventum said Thursday it has struck a deal to buy wound care company Acera Surgical for $725 million in cash.
    • “The deal, which features up to $125 million in milestones, will give Solventum control of a portfolio of synthetic soft tissue repair products. Stifel analysts said in a note to investors that they believe the synthetic market “is growing at a double-digit pace.”
    • “Acera is Solventum’s first acquisition since it spun out of 3M. Solventum executives made M&A part of their focus after selling the company’s purification and filtration business to Thermo Fisher Scientific for $4.1 billion.”

From the artificial intelligence front,

  • Cardiovascular Business reports,
    • “Heartflow’s Plaque Analysis software is an effective tool for the diagnosis and management of coronary artery disease (CAD), according to a new retrospective analysis of more than three years of data. The findings were presented at the American Heart Association’s Scientific Sessions 2025 conference.
    • “The FDA-cleared Plaque Analysis software was designed to evaluate coronary CT angiography (CCTA) results and provide cardiologists with an artificial intelligence (AI)-powered assessment of the patient’s coronary plaques. It delivers an interactive 3D model of the coronaries and identifies high-risk CAD patients who may benefit from immediate care. 
    • “This latest analysis included nearly 8,000 symptomatic CAD patients who participated in the FISH&CHIP study. All patients were treated with Plaque Analysis as well as Heartflow’s new Plaque Staging framework. Plaque Staging separates patients into one of four categories—mild, moderate, severe or extensive—based on AI-powered total plaque volume (TPV) measurements. According to Heartflow, this study represents the largest validation to date of the Plaque Staging framework.”
  • McKinsey & Co. explores “the coming evolution of healthcare AI toward a modular architecture.”
  • The Advanced Research Projects Agency for Health (ARPA-H) announced
    • “The AIR program [which’ aims to solve these problems by developing robots that can do parts of or entire surgical interventions on their own. The program’s focus is twofold: first, to develop autonomous robotic systems that can perform thrombectomies, making curative stroke care available to all Americans. Second, to create very small, mechanical, electronic, or hybrid devices (microbots) that can perform medical procedures independently, revolutionizing healthcare delivery.
    • “Notice ID: ARPA-H-SOL-26-146
      • ARPA-H invites interested parties to review the solicitation, which is posted and maintained on SAM.gov. The solicitation outlines the opportunity and its requirements, key dates and deadlines, submission documents and templates, evaluation criteria for submissions, and information on how to apply.
    • “Key Dates:
      • Proposers’ Day: December 16, 2025, Bethesda, MD (Hybrid)
      • Solution Summaries due: January 26, 2026
      • Proposals due: March 30, 2026
    • “Reminder: Dates are estimates and are subject to change. Please reference the solicitation for the most up-to-date information.”

Tuesday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “Federal employees will be able to contribute more to their Thrift Savings Plan accounts next year. The IRS increased the maximum annual contribution limit to $24,500, which is a $1,000 increase over 2025. Additionally, employees aged 50 or older can save more money through their catch-up contributions. And if employees are aged 60 to 63, they can save even more with a higher catch-up contribution of $11,250. (IRS increases annual TSP savings limit for 2026 – IRS)”
  • The Wall Street Journal tells us,
    • “Calley Means, a confidant to health secretary Robert F. Kennedy Jr., is taking a permanent post in the Trump administration, where he is expected to serve as a bridge between the Make America Healthy Again movement and President Trump’s broader MAGA coalition.
    • “Means, who earlier this year served in a temporary role at the White House, has been tapped to be a senior adviser in Kennedy’s Department of Health and Human Services, charged with helping to ensure the success of the MAHA movement’s policy goals, according to people familiar with the matter.
    • “As of Tuesday, Means was listed in the department’s personnel directory—which is public—as a senior adviser in the office of Assistant Secretary for Health Brian Christine.”
  • Per an AHIP news release,
    • “Health plans contribute to the health and economic stability of communities throughout America. A new comprehensive report from AHIP offers a detailed state-by-state view of health coverage and underscores the indispensable role of health plans in communities nationwide. 
    • “Health plans support the health and well-being of Americans in all 50 states by delivering high-quality coverage and doing everything they can to shield consumers from the rising cost of care,” said Mike Tuffin, AHIP’s President and CEO.
  • The American Hospital Association News notes,
    • “The AHA and the Federation of American Hospitals Nov. 18 released a study conducted by Dobson | DaVanzo, underscoring the threat to patient care by expanding physician-owned hospitals in rural communities. The study found that if a new POH opens in the same market as a full-service rural hospital, the full-service hospital’s financial stability would be negatively affected as the POH would siphon off healthier and commercially insured patients, risking access to care and community jobs. 
    • “Full-service hospitals across the country are struggling, and rural hospitals are particularly vulnerable to headwinds. … Removing restrictions on POHs, which are notorious for selectively picking the healthiest and wealthiest patients and allowing them to open near full-service rural hospitals will jeopardize access to 24/7 care in rural America,” write Don May, FAH executive vice president of policy, and Ashley Thompson, AHA senior vice president of public policy analysis and development, in an accompanying blog.” 
  • The Centers for Medicare and Medicaid Services released today a new edition of the Section 111 user guide for group health plans, which term includes FEHB and PSHB plans.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved a new medication for a rare genetic condition in a decision that represents a long-awaited milestone for the drug’s developer, biotechnology company Arrowhead Pharmaceuticals. 
    • “The agency on Tuesday cleared the therapy, Redemplo, for familial chylomicronemia syndrome, or FCS, a rare condition that disrupts the body’s ability to break down fats in the bloodstream. It’s been specifically approved for use alongside a diet to help reduce levels of those fats, or triglycerides, in adults with FCS. The drug is self-administered via a subcutaneous injection once every three months.” 

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Health officials on Monday linked for the first time the measles outbreak that began in Texas with another in Utah and Arizona, a finding that could end America’s status as a nation that has eliminated measles.
    • “The news came in a phone call, a recording of which was obtained by The New York Times, among officials from the Centers for Disease Control and Prevention and state health departments.
    • “The chain of transmission began in January, in a conservative Mennonite group on the western edge of Texas and spread to Oklahoma and New Mexico.
    • “Countries lose their elimination status after 12 months of sustained transmission. If the outbreak cannot be extinguished by January, the anniversary of the first cases in Texas, the United States will lose what is known as “elimination status” as determined by the World Health Organization, which it has had for 25 years.”
  • Beckers Hospital Review informs us,
    • “Influenza activity remains low but is increasing across the U.S., according to the CDC’s latest FluView report. 
    • “The agency updated data on flu trends Nov. 14, offering the first national snapshot of respiratory virus activity since September. The update follows a nearly two-month blackout in national reporting, during which states had to pause dashboard updates or rely on internal data amid the federal government shutdown.
    • “Less than 1% of ED visits were flu-related, a figure that remained relatively stable compared to the previous week. However, flu-related ED visits are rising among children. The virus accounted for about 1% of visits among children 4 and younger, and 1.3% among those ages 5-17. 
    • “Nationally, 1,665 patients with laboratory-confirmed influenza were admitted to the hospital, up slightly from the previous week. Overall, flu activity remains low, with all states reporting “minimal” or “low” activity. 
  • NBC relates,
    • “While the average age for being diagnosed with heart disease in the United States is typically in the mid-60s for men and early 70s for women, the factors, such as high blood pressure, diabetes and bad cholesterol levels, can start years, sometimes decades, earlier. 
    • “A new online heart risk calculator could help younger adults learn whether they’re likely to develop heart disease, as much as 30 years in the future, according to a study published in the Journal of the American College of Cardiology on Monday. That’s a significantly longer time period compared with traditional screenings, including the Framingham risk calculator or the ASCVD Risk Estimator Plus, which measure a 10-year risk for people ages 40 and older. 
    • “This tool was motivated by helping younger adults understand their long-term risk for heart disease,” said senior study author Sadiya Khan, the Magerstadt professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine. “We all procrastinate, but prioritizing health has to start today — and can with this tool.”
  • Per CNN Health,
    • “Starting prenatal care after the first trimester of pregnancy appears to be a growing yet dangerous trend in the United States, according to a new report.
    • “The report, released Monday by the infant and maternal health nonprofit March of Dimes, says that only about 75% of babies last year were born to mothers who started prenatal care in the first trimester of pregnancy.
    • “We’ve always known that getting that prenatal care started early is important,” said Dr. Michael Warren, March of Dimes’ chief medical and health officer. He added that now, in the United States, it’s moving in the “wrong direction.” * * *
    • “The new March of Dimes report gives the United States a D+ grade for having a preterm birth rate of 10.4% for the third year in a row.
    • “Sadly, I actually have to say that there was nothing that surprised us” in the new report, said Divya Sooryakumar, the vice president of programs and impact of the maternal health nonprofit Every Mother Counts, who was not involved in the report.”
  • BioPharma Dive points out,
    • “With new, positive data in hand, Merck & Co. plans to move its cardiovascular drug Winrevair into late-stage testing as a treatment for a condition often caused, at least in part, by high blood pressure.
    • “This condition — known as heart failure with preserved ejection fraction, or “HFpEF” — is common, affecting more than half of the roughly 6.7 million people in the U.S. believed to be living with heart failure. In these people, the heart’s main pumping chamber stiffens over time due to a variety of possible factors, including age, obesity and hypertension. While the chamber still pumps a “normal” amount of blood, patients with HFpEF can experience fatigue, shortness of breath, as well as life-threatening health complications.”
    • “The Food and Drug Administration has already approved several medicines for HFpEF, among them AstraZeneca’s Farxiga, Novartis’ Entresto, and Eli Lilly and Boehringer Ingelheim’s Jardiance. Merck has been trying to expand that list with Winrevair, a first-of-its-kind therapy that works by regulating signals from “activin” proteins that spur cell growth and division. In heart failure, the over-production of certain cells, molecules and proteins can harden the organ and impair its function.
    • “On Tuesday, Merck announced Winrevair had hit the main goal of a mid-stage clinical trial that enrolled 164 adults with high blood pressure in their pulmonary arteries caused by HFpEF.” 
  • and
    • “An experimental pill from Roche succeeded in a Phase 3 trial in early-stage breast cancer, helping prevent recurrence for longer than standard hormone therapies when administered after surgery in people with a common form of the disease.
    • “Roche didn’t provide specifics, but said that its drug, known as giredestrant, successfully extended disease-free survival compared to hormone therapy in people with ER-positive, HER2-negative breast cancer following surgical removal of a tumor. A “clear positive trend” was also observed on survival, though Roche said it’s too early to tell whether treatment clearly extended lives. 
    • “Giredestrant is part of a new class of oral “selective estrogen receptor degraders,” or SERDs, that aim to supplant a decades-old injectable therapy. So far, these drugs have largely only proven helpful for a particular subset of patients with advanced disease. Roche’s medicine is the first so far to show a benefit in the “adjuvant” setting, though others are also in late-stage testing.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Former Food and Drug Administration Commissioner Scott Gottlieb, M.D., is joining the board at industry giant UnitedHealth Group.
    • “The company announced the move Tuesday, with CEO and Board Chair Stephen Hemsley saying Gottlieb’s “exceptional healthcare career in both the public and private sectors” will bring valuable insight to the company.
    • “He is an innovator who constantly advocates for a more integrated healthcare approach supported by the latest technology,” Hemsley said. “We welcome his deep expertise and thought leadership as we strive to help people live healthier lives and make the health system work better for everyone.”
    • “Gottlieb served as the FDA Commissioner from 2017 to 2019, and during his tenure, he focused on transparency, patient safety and promoting competition. He took on the opioid epidemic and youth tobacco use during his time at the agency.”
  • Healthcare Dive adds,
    • “Optum Health, the care delivery arm of UnitedHealth, has tapped Krista Nelson as its new CEO effective immediately. Nelson announced the C-suite reshuffling via LinkedIn last week. 
    • “The executive has worked for UnitedHealthcare, UnitedHealth’s payer arm, off and on since 2009, according to her LinkedIn. Nelson was last responsible for overseeing the growth of government programs before switching over to UnitedHealth’s health services division Optum
      in May, when she was tapped as COO of Optum Health.
    • “Now, Nelson replaces Dr. Patrick Conway as the chief executive of Optum Health. Conway has been CEO of Optum since May and CEO of Optum Health since June.
    • “Conway will remain in his post as CEO of Optum following the reshuffling, according to his LinkedIn.”
  • Per Fierce Healthcare,
    • “Cigna Healthcare has unveiled Clearity, a new, copayment-only health plan designed to promote transparency and predictability.
    • “The new plan leans on Cigna’s in-house suite of artificial intelligence tools to make it easier for enrollees to make decisions for their care by arming them with critical information such as upfront pricing and verified patient reviews within a simple digital experience.
    • “The plan features a tiered copay model that does away with deductibles and coinsurance, Cigna said. Employers that select Clearity as an option can choose from five different packages with different cost-sharing options that don’t require narrowing networks or restricting access.
    • “Each package includes four in-network tiers and one out-of-network tier, according to the announcement.”
  • and
    • “Employers expect to see health benefits rise by 6.7% in 2026, reaching more than $18,500 per employee on average, according to a new report.
    • “Analysts at Mercer estimate that health costs in 2025 reached an average of $17,496 for each employee, growth of 6%. That’s a rate that outpaced inflation and wage growth, according to the report.
    • “The increase was driven by a sharp spike in prescription drug spending, which increased by 9.4% on average for large employers, or firms with at least 500 employees. Within that, large employers were more likely to cover GLP-1 drugs for weight loss this year, with 49% offering coverage compared to 44% in 2024.”
  • Per Fierce Pharma,
    • “Only days after revealing an unsolicited buyout bid from Lundbeck, Avadel—which has already signed an agreement to sell itself to Alkermes—has officially determined that the Lundbeck offer is sweeter.
    • “After “discussions and negotiations” with Lundbeck and separate consultations with its advisors, Avadel on Monday confirmed that it views the Lundbeck deal as a “superior company proposal.”
    • “The distinction is important because under Avadel’s existing transaction agreement with Alkermes, the latter company now has five business days to “discuss or negotiate in good faith” any potential amendments to its prior offer. Back in October, the companies got together on a $2.1 billion buyout agreement.
    • “Avadel says Lundbeck’s offer is worth up to $2.4 billion. The proposal features a $21-per-share upfront payment plus a contingent value right worth up to $2 per share based on future sales performance of Avadel’s narcolepsy drug Lumryz and pipeline candidate valiloxybate.”
  • Beckers Hospital Review lets us know,
    • “Novo Nordisk is temporarily offering doses of Type 2 diabetes drug Ozempic and weight loss medication Wegovy for $199, the drugmaker said Nov. 17. 
    • “Between Nov. 17 and March 31, self-paying patients of Wegovy or Ozempic can order their first two months’ worth of the medications for $199 per month, Novo Nordisk said. The discount applies to the two lowest doses, 0.25 and 0.5 milligrams, which are the recommended dosages for the first two months. 
    • “Following the first two months of treatment, self-paying patients will be eligible to order Wegovy or Ozempic for $349 per month. On Nov. 6, Novo Nordisk and the U.S. government reached a pricing agreement to sell Ozempic and Wegovy for $245 through Medicare and Medicaid, with a $50 copay for patients. The monthly prices will be $350 through TrumpRx, a direct-to-consumer website set to launch in early 2026. 
    • “GoodRx, Costco, WeightWatchers, CVS and other pharmaceutical retailers will participate in the offering.” 
  • The Wall Street Journal adds,
    • “The trillion-dollar club has become crowded with mostly tech names riding the AI boom. Eli Lilly LLY might soon join them for a far different reason: the weight-loss bonanza.
    • “Crucially, Lilly’s trajectory doesn’t hinge on artificial-intelligence sentiment or cloud-spending cycles that investors are suddenly questioning. In fact, it could even benefit from an investor rotation away from technology into other sectors. Its staying power above a $1 trillion market value will come down to two questions: how quickly it can expand the obesity-drug market and how completely it can dominate it. 
    • “On both fronts, its future looks promising. This year, Lilly has moved sharply ahead, securing Medicare access while widening its lead over Wegovy maker Novo Nordisk NOVO.B. That is why investors shouldn’t assume the rally stops at a trillion. 
    • “The key thing to remember is that—much like the AI boom—the GLP-1 surge is still in its infancy. Lilly only began selling its weight-loss drug Zepbound in late 2023, and the Food and Drug Administration only declared an end to a supply shortage of obesity drugs last year. As production has scaled up and new clinical data has emerged, Zepbound has pulled ahead of Wegovy. Despite Zepbound’s later launch, Lilly now captures a clear majority of new obesity-drug prescriptions, a sharp shift in market dynamics.”
  • Per Beckers Payer Issues,
    • “Medica plans to purchase certain contracts and assets from UCare as the latter’s legacy business winds down operations next year, the two companies said Nov. 17.
    • “We have the opportunity to build upon both Medica’s strengths and UCare’s legacy, allowing Minnesotans to continue to have a health care experience that ensures they feel cared for,” Medica CEO Lisa Erickson said.
    • “The agreement encompasses UCare’s Medicaid and ACA businesses that cover more than 300,000 Minnesotans. The transaction is expected to wrap during the first quarter of 2026. Individuals in UCare’s 2026 Medicaid and individual and family plans will still receive services without interruption.”
  • Per MedTech Dive,
    • “Medtronic’s pulsed field ablation business took off last quarter as competition in the space continues to heat up nearly two years after products first launched.
    • “PFA sales grew by more than 300% year over year in the U.S. and outside the U.S. in the second quarter of Medtronic’s fiscal 2026, according to materials released ahead of Tuesday’s earnings call. The company did not report specific sales figures.
    • “The technology fueled growth for the company’s overall cardiac ablation solutions business, or CAS, where sales increased by 71% year over year organically in the fiscal second quarter. Medtronic’s CAS business is steadily climbing as PFA adoption continues: The unit’s sales grew by nearly 50% and 30% in the company’s previous two fiscal quarters.”

From the artificial intelligence and electronic health records front,

  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a new $2 million Caregiver Artificial Intelligence Prize Competition to support the 1 in 4 Americans serving as caregivers for older adults and people with disabilities.
    • “This initiative through HHS’ Administration for Community Living (ACL) recognizes the millions of caregivers who support aging relatives and loved ones with disabilities. Their compassion and commitment form the backbone of America’s long-term care system, helping older adults and people with disabilities live with dignity and independence at home and in their communities.” * * *
    • “For updates on the competition, visit ACL’s Caregiver AI Prize Competition page.”
  • Fierce Healthcare reports,
    • “Aetna is rolling out a new artificial-intelligence-powered, conversational tool designed to make it easier for members to understand and navigate their health and benefits.
    • “The AI assistant is embedded in the insurer’s website and member app to readily answer questions that they may have about benefits and coverage, with session awareness that makes the experience feel less like a traditional chatbot. And members do not need to use healthcare jargon to secure answers, according to the company.
    • “For example, a member is told by their doctor that they need surgery. They can ask the assistant about their coverage for the procedure and receive a full and personalized breakdown of their costs and options, including estimates for fees and copayments.”
  • Healthcare Dive relates,
    • “Humana and Epic are partnering to speed patient appointment check-in and coverage verification for Medicare Advantage beneficiaries, the companies said Tuesday. 
    • “The new features are included in the electronic health record vendor’s payer platform, which allows insurance details from Humana to be automatically shared with providers before patients arrive at appointments, according to a press release. 
    • “The collaboration is an early result of an initiative from the Trump administration that aims to boost health data sharing and reduce repetitive, paper-based processes in healthcare, the companies said.” 
  • Beckers Health IT tells us,
    • “Oakland, Calif.-based Kaiser Permanente recently completed one of the largest EHR consolidations in healthcare history, migrating about 40 million patient records.
    • “In early 2025, the 40-hospital system merged 12 instances of its Epic EHR into two: in its Northern California and Southern California markets. In each case, the health system transferred roughly 20 million patient records with less than three hours of downtime and no canceled appointments or delayed procedures.”
    • The article also features a Beckers interview with “Neil Cowles, chief information and technology officer of Kaiser Permanente, to learn more.”

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.”