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.”