Weekend Update

David Ermer–CDC, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare–
  • Roll Call reported on October 3, 2025,
    • “Senators left town Friday afternoon for the weekend after another set of unsuccessful votes to reopen the government, but a renewed flurry of bipartisan discussions on the floor provided at least a faint glimmer of hope that agreement could be reached.
    • “Republicans involved in the talks said there’s a deal to be had on a stopgap funding bill with a sidecar commitment on two fronts.
    • “One is to take up legislation dealing with expiring health insurance subsidies by Nov. 1, when open enrollment begins. The other is to pass regular, bipartisan full-year appropriations bills that would make it harder for President Donald Trump and White House budget director Russ Vought to arbitrarily cut programs they don’t like.”
  • Govexec adds,
    • “Even as the shutdown drags into its second week, federal workers will not experience any immediate delays to their pay. The next official pay date, in which most feds would be missing parts of their normal paychecks, is not until mid-October, though the exact timing will depend on which federal entity disburses their salaries. Paychecks otherwise set to hit accounts at the end of the month would be delayed in their entirety, if the shutdown continues until that point.”
  • The House of Representatives announced on October 2, 2025, that “Pursuant to clause 13 of Rule I, the Chair announced the Speaker’s designation of the period from Tuesday, October 7, 2025, through Monday, October 13, 2025, as a “district work period.” October 13 is a federal holiday.
  • The U.S. Supreme Court begins its October 2025 term today.
  • NPR Shots lets us know that as of October 2, 2025, the acting CDC Director has not adopted the September 18-19 Covid-19 vaccine recommendations of the Advisory Committee on Immunization Practices.
    • “The [final actions] are necessary for the federal Vaccines for Children Program to start shipping the vaccines to doctors, health departments and others. About half of U.S. kids are eligible for shots through the program.” * * *
    • “The CDC’s delay has also forced adults seeking vaccination to continue navigating an often confusing and frustrating patchwork of state rules that have, in many places, made it difficult if not impossible for them to get vaccinated too. Even though many states have taken steps to make it easier for people to get the vaccines, some still require prescriptions, and some pharmacists are still turning away people who can’t document they meet new eligibility requirements.”
  • Per Fierce Pharma,
    • “After reacquiring the rights to its non-vaccine flu preventative last year, Cidara Therapeutics has secured federal support to develop and produce the candidate, dubbed CD388, in the U.S.
    • “The Department of Health and Human Services’ (HHS’) Biomedical Advanced Research and Development Authority (BARDA) has graced Cidara and its flu asset with an award worth up to $339 million, Cidara said Thursday. The deal includes confirmed funding of $58 million over two years, which will be used to stand up domestic manufacturing for CD388 in the U.S. and help Cidara establish its “initial commercial supply chain,” the company explained in an Oct. 2 press release.
    • “That initial tranche of cash will also fuel a clinical trial comparing a higher-concentration formulation and different presentations of CD388, help the company further characterize the asset’s activity against pandemic flu strains in nonclinical models and kick off development of trial protocols for expanded populations, Cidara said.”
  • and
    • “Friday, the regulator unveiled a new pilot prioritization program that aims to speed up approval review times for generic drug makers that test and manufacture their products in the U.S.
    • “Specifically, generics companies that file abbreviated new drug applications that meet the “FDA’s domestic production and bioequivalence testing requirements—including the use of “exclusively domestic sources for API”—will become eligible for priority review, the agency explained in an Oct. 3 release.
    • “The pilot program aligns with the onshoring ethos that has defined many of the administration’s pharma-related policy maneuvers this year.”
  • HR Dive tells us that last week the Labor Department clarified overtime pay requirements in new opinion letters. The second batch of wage-and-hour letters released during the second Trump administration addressed a joint employer scenario as well as firefighter emergency pay.”

From the public health and medical / Rx research front,

  • The New York Times explains why brittle bones aren’t just a woman’s problem. More men are now living long enough to develop osteoporosis. But few are aware of the risk, and fewer still are screened and treated.
  • Per Medscape,
    • “Oral semaglutide showed similar reductions in cardiovascular events in patients with type 2 diabetes (T2D) and cardiovascular or chronic kidney disease with and without peripheral artery disease (PAD), according to a new SOUL trial subanalysis. Overall, however, patients without PAD experienced the most benefit.
    • “Major adverse limb events (MALE), including both acute limb ischemia and chronic limb ischemia, were also lower in patients treated with oral semaglutide than placebo, regardless of whether patients had PAD or not.
    • “PAD is common and significantly increases risk of cardiovascular and limb events, yet [it] is an under-recognized comorbidity in patients with type 2 diabetes,” said Matthew Cavender, MD, interventional cardiologist at the University of North Carolina at Chapel Hill, who presented the data at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.
    • “Therapeutic options that reduce cardiovascular and limb events are limited, and there’s an urgent need for novel strategies to improve outcomes in this vulnerable population,” he said.”
  • and
    • “In the prevention of kidney disease in patients with type 2 diabetes (T2D) and mildly reduced kidney function, SGLT2 inhibitors (SGLT2i) showed a stronger benefit than GLP-1 receptor agonists (RA) and other diabetes drugs, however, an SGLT2i/GLP-1 combination showed greater efficacy than either therapy alone, results of a new study showed.
    • “Importantly, the utilization of a clinical risk score could further improve the treatment efficacy by assigning patients to the most appropriate therapy, the study authors noted.
    • “Our take-home message is that SGLT2 inhibitors give better kidney protection than GLP-1 receptor agonists, regardless of the individual, and clinical risk scores could help identify high-risk individuals who might benefit from SGLT2/GLP-1 combination treatment,” first author Thijs Jansz, MD, University of Exeter, Exeter, England, told Medscape Medical News.
    • “The study was presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.”
  • and
    • “At the 28th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO 2025), Marianela Aguirre Ackermann, MD, presented that limited awareness, stigma, and time constraints during consultations prevent internists from discussing metabolic and bariatric surgery with patients, leaving the vast majority of individuals with obesity without appropriate care.
    • “Aguirre Ackermann is a specialist in diabetes and internal medicine at the Endocrinology, Obesity, and Nutrition Center (Centro CIEN) in Buenos Aires, Argentina.
    • “Speaking with Medscape’s Spanish edition, Aguirre Ackerman highlighted TheLancet Commission’s framework, which distinguishes “preclinical” from “clinical” obesity, as a tool to bridge the gap between consultation and surgery.
    • “It provides a clear definition and emphasizes the health impact of excess weight,” she stated.
    • “A cultural shift is needed; we need to look at the patient differently. In other words, the patient is no longer a scale, no longer an excess of kilograms, but rather an excess of adiposity that can cause disease,” she said.”

From the U.S. healthcare business front,

  • The New York Times points out how private equity oversees the ethics of drug research. Many drug trials are vetted by companies with ties to the drugmakers, raising concerns about conflicts of interest and patient safety.
  • Medscape discusses the potential role of oral GLP-1 drugs in weight management.
    • Only a fraction of the people who could benefit from taking obesity medications are currently doing so. A wider array of affordable, effective treatment options could help more people. Could oral GLP-1s be one of them? Yes, experts say, but there are some caveats [, which are discussed in the article].
  • Per MedTech Dive,
    • “Boston Scientific aims to become the market leader in the electrophysiology category as the device maker looks to pulsed field ablation to drive growth. 
    • “Our new vision is not just to be a leader in pulsed field ablation, but to be a leader in overall electrophysiology,” Nick Spadea-Anello, Boston Scientific’s global president of electrophysiology, said at a Tuesday investor meeting.”
  • and
    • “Boston Scientific is working on a new version of its Watchman device, company leaders said at a Tuesday investor presentation. 
    • “Angelo De Rosa, global president of Boston Scientific’s Watchman business, said the company is working on a version of Watchman that “will provide an answer, stability and unprecedented adaptability to each possible anatomy.”
    • “The company plans to begin enrollment next year for an upcoming U.S. investigational device exemption study and hopes to launch the device in the second half of 2027 or early 2028.”