From the Washington, DC,

• The Wall Street Journal reports,
  • “The Senate was driving toward a deal to end the record government shutdown, with the top Senate Republican saying to expect a vote as soon as Sunday but also warning that an unpredictable negotiation could still hit some snags.” * * *
  • “We’re close to the finish line,” said Sen. Catherine Cortez Masto (D., Nev.), a centrist who is one of three Democrats who have repeatedly voted to fund the government.
  • “The Senate Appropriations Committee released three full-year funding bills, covering veterans’ programs and the construction of military housing as well as the Agriculture Department and the legislative branch. An interim measure expected to temporarily fund the rest of the government still hadn’t been released, and Republicans didn’t specify how the main Democratic demand to extend expiring healthcare subsidies would be handled.
  • “Any deal would still need approval in the House of Representatives, which has been out of session since Sept. 19. House Speaker Mike Johnson (R., La.) has put members on notice that he would give them 48 hours to return in the event the Senate passed a spending bill.
  • “A key development that appeared to break the logjam in the negotiations was that Senate Republicans proposed that some healthcare funding be provided directly to households rather than be used to pay for a one-year extension of enhanced ACA subsidies.
  • “That GOP proposal involves sending federal money into flexible-spending accounts instead of to insurance companies that use the money to offset the cost of premiums, so consumers pay a smaller monthly bill. The money could be used to cover deductibles and other out-of-pocket costs, which Republicans see as a way to give consumers more choice and control healthcare inflation.”

• The cloture resolution to the continuing resolution to end the shutdown passed by the minimum 60-40 vote last night. Roll Call explains,
  • “The vote had been held open for over two hours allow for Sen. John Cornyn, R-Texas, the 60th vote, to return to the Capitol. He’d been back home over the weekend officially filing as a candidate for re-election next year in his state’s Republican primary.”
  • Eight Democratic senators voted aye per the Wall Street Journal.

• Roll Call adds,
  • “The new continuing resolution would extend current funding levels through Jan. 30, along with three full-year appropriations bills covering the Departments of Agriculture and Veterans Affairs as well as legislative operations. It also carries a host of “extender” provisions for authorizing committees that haven’t completed work on other bills, mostly through January, though there is a one-year farm bill extension.” * * *
  • “Senate Majority Leader John Thune, R-S.D., said the arrangement includes a commitment to vote on a Democratic-drafted extension of expanded health insurance subsidies by mid-December, ahead of their Dec. 31 expiration.
  • “Another key provision for Democrats who’d been on the fence would reverse mass layoffs announced by the Trump administration since the shutdown began Oct. 1, at least while the government remains open.”

• The Senate needs to enact the continuing resolution which requires a majority vote and then the continuing resolution heads over to the House of Representatives again for a majority vote. The President must sign the continuing resolution to enact it. Because Tuesday is a federal holiday, the shutdown will continue into later this week.

• There are no Congressional committee meetings scheduled for this week.

• The Federal Benefits Open Season begins tomorrow. OPM notes
  • “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 8, 2025, for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) and Postal Service Health Benefits Program (PSHB) ends at 11:59 pm, per the location of your electronic enrollment system, on Monday December 8, 2025.”

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

• The New York Times reports,
  • “Merck, the company that introduced statins to the world nearly 40 years ago, has a new, intensely powerful pill that can slash levels of dangerous LDL cholesterol to levels almost never seen in adults.
  • “The new pill, enlicitide, blocks a liver protein, PCSK9, that slows the body’s ability to clear cholesterol. With most PCSK9 blocked, LDL levels plummet and rates of heart attacks and strokes in high risk patients fall by up to 20 percent in just the first year.
  • “At least six million adults in the United States are eligible for drugs that block PCSK 9.
  • “Merck’s head of research said the goal is to make the pill affordable. It would be an alternative to expensive biweekly or monthly injections of monoclonal antibodies that do the same thing. But only around one percent of eligible patients take the injections, which include Praluent by Regeneron and Sanofi, and Repatha by Amgen. Many patients don’t want to inject themselves, and insurers put up obstacles to paying, cardiologists say. The drugs’ list prices are more than $500 a month.”

• STAT News adds,
  • “A cholesterol-lowering injection that’s been on the market for nearly a decade has now shown its power to cut cardiovascular events in people considered at high risk but who haven’t yet suffered a heart attack or stroke.
  • “A study published Saturday in the New England Journal of Medicine and presented here at the American Heart Association’s scientific sessions concluded that Repatha reduced coronary heart disease death, heart attack, and stroke by 25% overall and lowered first heart attacks by 36% in people with high cholesterol but no history of these serious events. Their high cholesterol meant they were already taking statins or other cholesterol-lowering medications.
  • “Repatha, made by Amgen, also reduced cardiovascular problems and prevented the need for stent and bypass procedures, meeting both endpoints of the clinical trial called VESALIUS-CV. That’s better than statin therapy, an older class of cholesterol-lowering drugs that became the best-selling medicines in the world.” 

• The Washington Post informs us,
  • “One of the largest studies ever conducted on the link between the shingles vaccine and brain health offers insight into how the disease increases dementia risk.
  • “People who experienced multiple episodes of shingles had a higher risk of dementia for several years after the second outbreak, the study found, compared with those who had it only once.
  • “The findings, published recently in the journal Nature Medicine, provide additional evidence for why getting vaccinated for shingles could help protect the brain.
  • “Shingles stems from the varicella-zoster virus, which causes childhood chickenpox and hibernates in the nervous system. As people age, the virus reactivates but often is “beaten back down by the immune system,” said Pascal Geldsetzer, a professor of medicine at Stanford University and one of the study’s authors. But sometimes, he said, “it reactivates fully” and then you get shingles’ telltale symptoms, the burning, tingling, painful blisters and rash.”

• Per Medscape,
  • “Continuous glucose monitoring (CGM) may be appropriate and potentially beneficial for patients undergoing dialysis, especially those with diabetes, according to a prospective community-based cohort study.
  • “The findings, published in the Journal of the American Society of Nephrology, demonstrated that in maintenance dialysis, CGM frequently identified episodes of hyperglycemia and hypoglycemia that may not be clinically evident.
  • “The authors noted that while CGM provides detailed glycemic profiles, few studies have evaluated its use in patients with kidney failure, with most limited to small or selective cohorts. They sought to address this by designing a study that characterized the spectrum of glycemia and its determinants in a large, demographically diverse population of patients receiving maintenance dialysis.”

From the U.S. healthcare business front,

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