Thursday report

Federal employment benefits

Thursday report

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

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The government shutdown is expected to continue into next week as the Senate is expected to adjourn Oct. 23 with no plans to vote this weekend. The chamber Oct. 22 failed for a 12th time to advance the House-passed continuing resolution to extend government funding. The House remains out of session with no plans to return at this time. Lawmakers remain at an impasse.”
  • and
    • “The Senate Committee on Health, Education, Labor and Pensions Oct. 23 held a hearing discussing the 340B Drug Pricing Program and its growth and impacts on patients. The AHA provided a statement to the committee in support of the program and highlighted benefits for patients and hospitals, such as lowering drug costs and subsidizing chronic underpayments from Medicare and Medicaid.
    • The AHA also discussed the impact of 340B in rural communities. “Most rural hospitals lose money when providing critical medical services needed in their communities and therefore rely on 340B savings to remain operational and provide specialty care,” the AHA wrote. “If these services were unavailable in their communities, rural patients would be forced to drive far distances to access the same level of care, which for many would be impossible.”
  • The Senate did adjourn until Monday late this afternoon.
  • Federal News Network adds,
    • “A Republican measure to immediately pay federal employees who are working without pay under the shutdown failed to advance in the Senate on Thursday. But some lawmakers still appeared optimistic about reaching a bipartisan agreement on paying federal employees within the next few days.
    • “Democrats largely voted down the GOP’s “Shutdown Fairness Act,” resulting in a vote of 54-45 on the Senate floor. The Republicans’ motion on the bill failed to reach the 60 votes required to “invoke cloture” — a type of vote that limits debate to more quickly move legislation to a final vote.
    • “Three Democrats — Sens. John Fetterman (D-Pa.), Jon Ossoff (D-Ga.) and Raphael Warnock (D-Ga.) — voted alongside Republicans on the motion. Sen. Tim Sheehy (R-Mont.) did not vote.” * * *
    • “Despite Thursday’s failed votes, Sen. Ron Johnson (R-Wis.), the lead co-sponsor on the Shutdown Fairness Act, expressed optimism for reaching a bipartisan agreement to pay federal employees while the shutdown continues.
    • “We’re basically in agreement here,” Johnson told reporters. “I’m willing to add furloughed workers, and now it’s just kind of down to the reductions in force … I don’t want to completely constrain the President, but I don’t mind making sure that Congress has a say in this as well.”
    • “I’m actually quite hopeful — I think we can fix it over the weekend,” Johnson added. “This could open up a path to opening the government as well.”
  • and
    • “The Centers for Medicare & Medicaid Services is temporarily bringing furloughed employees back to work to help individuals sign up for health insurance plans during the open enrollment period.
    • “CMS told employees in an email obtained by Federal News Network that it is bringing back its furloughed employees, starting Monday, Oct. 27.
    • “The agency said it will repurpose some of its funding to ensure furloughed and excepted employees are paid on time for days worked during the open enrollment period.
    • “CMS said all these employees “will be paid for the days you work” or take approved leave, beginning on Oct. 27. Employees working these days will receive a partial paycheck on Nov. 7.”
  • The Wall Street Journal notes,
    • “Lawmakers failed to provide a last-minute reprieve for air-traffic controllers and other federal workers who are set to miss their next paychecks due to the government shutdown, with legislation failing in the Senate and Republicans warning they didn’t expect any financial rescue from the administration.
    • “The expected lapse in pay exacerbates concerns over possible shortages of air-traffic controllers, a job that requires long, intense hours and sophisticated training. But worries about air travel could also help drive Republicans and Democrats to find a way out of the funding impasse, now into its fourth week. Absenteeism and air-travel problems played a central role in bringing about the end of the record monthlong lapse in President Trump’s first term.” * * *
    • “In 2019, the strain on air-traffic controllers was widely seen as helping bring the government shutdown to an end, after staffing shortages and sick calls began disrupting flights. So far, U.S. flight cancellations and delays have stayed generally in line with their level during the same period last year, according to data from FlightAware.
    • “Union officials say hardships are growing for airport workers.”
  • Tammy Flanagan, writing in Govexec, lets us know that “the government shutdown has raised lots of questions about the retirement process, and retirement benefits, for federal employees while agencies remain closed. Here are some of the most pressing answers.”
  • AHIP and the Blue Cross Blue Shield Association has posted a No Surprises Act survey concluding that
    • “The Independent Dispute Resolution (IDR) process itself is costly, diverting funds plans could otherwise have spent on patient care or used to lower premiums and patient cost-sharing.
    • “The vast majority of out-of-network claims covered by the NSA are resolved through prompt payment without dispute or further negotiation.
    • “IDR is being overused by some providers who submit high volumes of disputes, many of which are ineligible, which adds costs to the health care system.”

From the Food and Drug Administration front,

  • Biopharma Dive reports,
    • “The Food and Drug Administration has approved GSK’s multiple myeloma drug Blenrep, officially ending the hiatus of a medication pulled from the U.S. market three years ago.
    • “Yet the agency on Thursday issued a mixed decision in clearing the drug’s return. It approved Blenrep’s use alongside one regimen involving another myeloma medicine, Velcade, but not in combination with another therapy called Pomalyst. It also cleared Blenrep in people whose multiple myeloma has returned, or hasn’t responded, after at least two prior lines of therapy, instead of one, as GSK had requested.
    • “Still, in a statement, GSK Chief Scientific Officer Tony Wood referred to the decision as a “significant milestone.” Wood added that “there is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse and re-treating with the same mechanism of action often leads to suboptimal outcomes.”
    • “The clearance completes a turnaround for Blenrep, which was initially approved in 2020 but traveled an unusual path since.”
  • Yahoo relates,
    • Coca-Cola has issued a recall of three of its most popular soda brands after discovering potential metal fragments in certain batches. If you’ve got a cold soft drink chilling in your kitchen, there are key batch codes you’ll want to check—especially since thousands of cans have already been pulled from store shelves. Read on to find out whether your soda is affected, what to do if it is, and how to stay safe. * * *
    • “According to a Coca-Cola spokesperson, the recall was limited to select regions of Texas, specifically the McAllen/Rio Grande Valley and San Antonio areas. The company confirmed that no products outside these locations were impacted.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A new analysis of a major clinical trial affirmed that Wegovy, the popular obesity drug, lowers the risk of major heart issues like heart attacks and strokes in some adults, but showed that weight loss could not fully explain the cardiovascular benefits.
    • “How else, exactly, the drug protects the heart remains a mystery.
    • “Obesity is intricately linked with poor heart health, and losing excess weight can blunt the risk of cardiovascular concerns. But the analysis, published on Wednesday in The Lancet, found that a shrinking waist size — a measure of shedding belly fat — was responsible for only around a third of the observed cardiovascular benefits in people who took Wegovy. In their first 20 weeks of taking the drug, patients experienced cardiovascular benefits no matter how much weight they lost.
    • “As it stands now, we do not know how to account for that other roughly two thirds of the benefit,” said Dr. Michael Lincoff, a professor emeritus of medicine in the department of cardiovascular medicine at the Cleveland Clinic and an author of the paper.”
  • BioPharma Dive adds,
    • “Shares of Ventyx Biosciences, a San Diego-based drug company, nearly doubled Thursday morning after the company said an experimental medicine it’s been studying in people with obesity showed significant effects on cardiovascular risk factors in a mid-stage trial.
    • “The medicine, code-named VTX3232, failed to help trial participants lose more weight when given alone or as an add-on therapy to semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy. It did, however, significantly reduce biological markers of inflammation, fat levels and liver illness, Ventyx said late Wednesday.
    • “Analysts argue the results lend more support to Ventyx’s approach of fighting disease by focusing on an inflammasome known as NLRP3. Shares of a rival company also targeting NLRP3, BioAge Labs, jumped more than 30% in early trading Thursday.”
  • Per MedPage Today,
    • “Researchers estimated the long-term cardiovascular effects of sugar rationing in the United Kingdom dating back to World War II.
    • “Early life during this period of restricted sugar intake was tied to lower cardiovascular risks in adulthood after age 40.
    • “Risk reductions reached 20% for cardiovascular disease and 25% for myocardial infarction for people who spent the first 1,000 days after conception under sugar rationing.”
  • The American Medical Association lets us know what doctors wish patients knew about healthy eating.
  • Medscape lets us know what doctors wish patients knew about GLP-1 drugs and oral health.
  • Per Health Day,
    • “Poor blood sugar control in adolescents with type 1 diabetes (T1D) increases the risk for future complications, according to a study published in the October issue of Diabetes Research and Clinical Practice.
    • “Chris Moran, from Monash University in Australia, and colleagues examined the 30-year glycemic trajectory in children with early-onset T1D. The analysis included 30 children with T1D (1990 to 1992) participating in the Cognition and Longitudinal Assessment of Risk Factors study.”
  • Genetic Engineering and Biotechnology News relates,
    • “The link between an extra copy of chromosome 21 and Down syndrome (DS) has been well established for decades. What has not been clear was the genetic basis for the congenital heart defects that are associated with nearly half of babies born with Down syndrome. Now a new study in mice published in Nature describes how HMGN1 disrupts DNA’s packaging and regulation and how this impacts molecular levels in healthy heart development. Details of the work are published in a paper titled “Myocardial reprogramming by HMGN1 underlies heart defects in trisomy 21.”
    • “The work is the result of a collaboration involving scientists from Gladstone Institutes, Sanford Burnham Prebys, and elsewhere. As explained in the paper, the link to HMGN1 was made using human pluripotent stem cell and mouse models of Down syndrome. Specifically, “single-cell transcriptomics showed that trisomy 21 shifts human [atrioventricular canal] cardiomyocytes towards a ventricular cardiomyocyte state,” the scientists wrote. Then, “a CRISPR-activation single-cell RNA droplet sequencing screen of chromosome 21 genes expressed during heart development revealed that HMGN1 upregulation mimics this shift, whereas deletion on one HMGN1 allele in trisomic cells restored normal gene expression.” 
    • “According to Sanjeev Ranade, PhD, assistant professor in the Center for Cardiovascular and Muscular Diseases and Center for Data Science and Artificial Intelligence at Sanford Burnham Prebys, “what our paper did was address a major unresolved question: Yes, three copies of chromosome 21 causes DS, but why? What are the genes on chromosome 21 that are bad if you have them in three copies? How in the world do you try to find those genes?” Ranade is the first author on the paper and also a co-corresponding author. 
    • “While this study was done in mice, there are obvious benefits for research in people. Learnings from this study “could pave the way for treatments to help prevent heart malformations in people with Down syndrome and related heart defects, which would be a major win for patients and their families,” said Deepak Srivastava, MD, president and senior investigator at Gladstone, a pediatric cardiologist at University of California, San Francisco (UCSF). Srivastava is the senior author on the paper and one of its corresponding authors.”
  • and 
    • “Ewing sarcoma is one of the most common bone cancers seen in children, and if it spreads, it can be deadly. A study headed by researchers at the Institute of Mother and Child, Warsaw, have now found that combining first line therapy for Ewing sarcoma with a drug called pazopanib, which was originally developed for renal cell carcinoma, demonstrated striking success in treating a small group of young patients. 85% of the treated patients survived two years after diagnosis, and there was no disease progression for two-thirds of patients. The team calls for larger studies which can develop this treatment further.”
  • Beckers Hospital Review shares a survey of U.S. state based on the readiness to address the healthcare needs of their elderly populations.
    • “Hawaii is the most prepared state to address the healthcare needs of the U.S.’s aging population, while Oregon is the least, according to an analysis by Seniorly and CareScout. 
    • “Seniorly examined each state across three dimensions — population trends, financial readiness and healthcare capacity — to devise the ranking.”
  • The Washington Post answers reader questions about using artificial intelligence as a healthcare guide.
    • “Younger doctors, in particular, are turning to the technology for help with diagnosis and treatment decisions. Two medical educators told me that nearly all of their students and residents use OpenEvidence, a free AI tool trained on medical literature. Wolters Kluwer UpToDate, the gold-standard clinical reference used by as many as 90 percent of physicians, has also added AI features that generate tailored recommendations for specific patient scenarios.
    • “My advice is to frame your curiosity as collaboration, not challenge. You might say, “I was trying to learn more about menopause and found this information. What do you think of it?” You might even ask your doctor if she uses AI herself. That question can open the door to understanding whether the discomfort stems from the technology itself or from a deeper resistance to patients taking a more active role in their care.”

From the healthcare business front,

  • Beckers Hospital Review reports,
    • “GLP-1 prescribing in the US may have reached a plateau, new data suggests. 
    • “Prescribing rates remained stable from June to September, according to an analysis of EHR data from researchers at Truveta — a platform that includes de-identified patient data from more than 900 hospitals to support medical research advancements.
    • “In June, the overall prescribing rate for GLP-1s was 6.22%. By September, that figure was 6.5%, marking a 4.6% increase. The findings were published Oct. 14 in the preprint server medRxiv.“
  • and
    • “Patient experience scores across U.S. hospitals are rebounding slowly after pandemic-era declines. 
    • “According to a Press Ganey analysis of 10.5 million patient encounters released earlier in 2025, “recommend the hospital” scores rose from 69 in 2024 to 70.4 in early 2025, signaling a modest uptick in trust and satisfaction. Scores at medical practices and ambulatory surgery centers have each increased by several points since 2019, while inpatient scores have fallen by 2.2 points in the same period.
    • “The analysis results suggest that while patient experience is improving overall, the biggest strides are occurring outside hospital walls. Outpatient environments are benefiting from targeted digital investments, streamlined access and better communication, while inpatient settings still struggle with coordination, predictability and information flow.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its new “Launch Price and Access Report,” finding that drug launch prices continue to rise at a rate that exceeds inflation, gross domestic product (GDP) growth, and overall healthcare costs.
    • “ICER’s analysis focused on “net price,” or the actual price paid after rebates and discounts, offering crucial information to policymakers, given that most previous analyses of drug pricing trends focus on the publicly available “list price,” which does not always reflect the actual price paid.
    • “The report, using net prices, found that the inflation-adjusted median annual launch price of drugs increased by 51% from 2022 to 2024, while the annual list price increased 24% during the same period. Even after accounting for the differences in the mix of drugs approved each year (by holding certain characteristics constant, like the number of gene therapies approved), the annual net launch price increased by 33% per year.
    • “ICER also conducted an in-depth review of the 23 drugs in scope that had been previously reviewed by ICER. The analysis indicated that aligning the prices of these therapies with ICER’s Health Benefit Price Benchmark (HBPB) could have saved approximately $1.3 to $1.5 billion in the first-year post-approval alone – savings that could have been redirected to higher-value drugs and services.’
  • Healthcare Dive tells us,
    • “Molina cut its 2025 earnings guidance for the third time this year on Wednesday, citing doggedly high medical costs particularly in its Affordable Care Act plans.
    • “The insurer now projects adjusted earnings per share of $14 this year, down from its prior estimate of “no less than” $19 from July. The earnings reduction is despite Molina now believing it will bring in higher premiums this year.
    • “Molina also posted third quarter results on Wednesday that beat analyst expectations on revenue but missed on earnings. The insurer’s stock plummeted 19% in aftermarket trading following the results.”
  • Fierce Healthcare informs us,
    • “Community Health Systems’ (CHS’) third-quarter performance blew past Wall Street’s expectations with year-over-year same-store gains and shareholder earnings that landed on the right side of zero.
    • “The Franklin, Tennessee-based company is the first of its for-profit peers to report this earnings season. Its stock is trading well above its closing value after hours—a change in pace from last quarter’s stumble.
    • “We were pleased with operating and financial results for the quarter, which generally met our expectations,” Kevin Hammons, president and interim CEO, said in Thursday afternoon’s release on the quarter’s performance.”
  • Per Fierce Pharma,
    • “Even as Roche executives on Thursday espoused confidence in the company’s resilience and growth potential over the next several years, a mix of exchange rate fluctuations and lackluster pharmaceutical sales led to a worse-than-expected third quarter for the Swiss drug giant.
    • “For the first nine months of 2025, Roche’s overall sales grew 7% year over year at constant currencies to 45.9 billion Swiss francs (nearly $58 billion), the company announced Thursday. The bulk of that growth can be attributed to the company’s pharmaceutical division, which has clocked sales growth of 9% at constant exchange rates over the nine-month stretch.
    • “As in previous earnings periods, Roche’s pharma momentum was attributed to the recent performance of Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus.”
    • “Roche’s earnings release reported the company’s sales performance from January through September, and in that span, all five of those franchises charted revenue increases. But looking at the period from July through September specifically, that shine lost some of its luster.”

Monday report

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

From Washington, DC,

  • Govexec reports,
    • “As the Senate continues to take failed votes to reopen the government, the chamber will soon shift to a new approach that would ensure on-time for feds working during the shutdown. 
    • “In its 20th day, Senate Democrats were expected to reject for the 11th time a short-term spending measure to fund agencies through Nov. 21. Senate Republicans are looking to ramp up pressure on Democrats by allowing normal paychecks for employees required to continue reporting to their jobs without immediate compensation during the shutdown. 
    • “Senate Majority Leader John Thune, R-S.D., told reporters he would on Monday evening take the first procedural step to bring the measure up for consideration, with a vote taking place either Wednesday or Thursday. 
    • “They’re all going to get paid eventually, but I think people who are working right now and not getting paid ought to be,” Thune said.” 
  • Before Congress overrides it, here’s a link to OPM’s 89-page long Guidance on Shutdown Furloughs, which the FEHBlog ran across today.
  • Kevin Moss, writing in Govexec, discusses “what FEHB changes mean for your 2026 health coverage. Premiums are shifting, and the government contribution varies. Here’s what to know to avoid surprises and save where you can.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has approved Rybelsus, Novo Nordisk’s oral semaglutide formulation, for reducing the risk of major adverse cardiovascular events in high-risk patients with type 2 diabetes. Rybelsus is officially the first oral GLP-1 drug approved for this indication.
    • “The FDA’s decision was largely based on data from the SOUL trial, which included data from more than 9,000 patients who were randomized to oral semaglutide or a placebo.[1] All patients had type 2 diabetes in addition to known atherosclerotic cardiovascular disease, chronic kidney disease or both. Overall, the study’s primary outcome—a composite of cardiovascular death, nonfatal heart attack or nonfatal stroke—was seen in 12% of oral semaglutide patients and 13.8% of placebo patients. This represents a 14% overall reduction, similar to the results associated with injectable semaglutide.
    • “The FDA originally approved Rybelsus in 2019 to improve glycemic control in adults with type 2 diabetes. At the time, it was the celebrated as the first GLP-1 drug available in pill form—and it still is six years later.”
  • Fierce Pharma adds,
    • “With the lupus treatment landscape poised for a shake-up, Roche is hitting the scene in the U.S. with a new green light for its long-approved blood cancer medicine Gazyva.
    • “Early Monday, Roche’s Genentech announced that the FDA cleared Gazyva (obinutuzumab) to treat adults with active lupus nephritis who are taking standard therapy.
    • “The drug will be given as four initial infusions during the first year of treatment, after which it can be administered twice yearly.” 
  • Per MedTech Dive,
    • “Ōura is pursuing Food and Drug Administration clearance of a blood pressure feature for its smart rings.
    • “Having engaged with the FDA, Ōura has received approval to study the feature in a population of users who are signed up to try experimental features of its devices, the company said Monday. 
    • “Participants will answer health questions. By combining the answers with data from the user’s ring, Ōura will assess the likelihood of the patient having high blood pressure.”

From the public health and medical / Rx research front,

  • The Washington Post reports on “four surprising things that may reduce your risk of Parkinson’s. Research on Parkinson’s is revealing several risk factors related to our lifestyles and environment, and you can act on some of them.”
    • “Parkinson’s disease, once considered relatively rare, is now one of the most common neurological disorders in the world, and the second most common after Alzheimer’s disease. The number of people living with Parkinson’s has more than doubled in the past 25 years to 8.5 million and is predicted to hit 25.2 million by 2050.”
    • “The hallmark symptoms of Parkinson’s — such as tremors, stiffness, and difficulty with balance and coordination — result from the deterioration of neurons in the basal ganglia, an area of the brain that controls movement. While 10 to 15 percent of cases are linked to inherited genetic mutations, the rest are considered “sporadic,” with no known cause.
    • “Although treatments are available that can manage symptoms, there is no cure or therapy that can slow disease progression. But ongoing research on Parkinson’s is revealing several risk factors related to our lifestyles and environment, some of which are actionable.
    • “For example, moderate to vigorous exercise may reduce one’s risk, according to a 2018 meta-analysis, and some studies have shown that healthy diets focused on whole, unprocessed foods might help. Last year, a study found that higher levels of exposure to air pollution were associated with an increased risk of Parkinson’s.”
    • The article offers more tips.
  • The New York Times points out,
    • For the first time, researchers restored some vision to people with a common type of eye disease by using a prosthetic retinal implant. If approved for broader use in the future, the treatment could improve the lives of an estimated one million, mostly older, people in the United States who lose their vision to the condition.
    • The patients’ blindness occurs when cells in the center of the retina start to die, what is known as geographic atrophy resulting from age-related macular degeneration. Without these cells, patients see a big black spot in the center of their vision, with a thin border of sight around it. Although their peripheral vision is preserved, people with this form of advanced macular degeneration cannot read, have difficulty recognizing faces or forms and may have trouble navigating their surroundings.
    • In a study published Monday in The New England Journal of Medicine, vision in 27 out of 32 participants improved so much that they could read with their artificial retinas.
  • The American Medical Association lets us know what doctors wish their patients knew about menopause.
  • Healio tells us,
    • “Exposure to elevated blood pressure through young adulthood was linked to cognitive decline by midlife.
    • “The trend was consistent across race and sex subgroups.”
  • NBC News reports,
    • “With age comes a natural decline in cognitive function, even among otherwise healthy adults without dementia. A new study finds that a cognitive training program may boost production of a brain chemical that plays a role in memory and attention.
    • “Participants who completed game-like activities through BrainHQ, an online subscription program, showed increased production of acetylcholine, sometimes called the “pay attention” chemical. The process that produces acetylcholine in the brain is called the cholinergic system.”
  • Per MedPage Today,
    • “Having shingles boosted the risk of major adverse cardiovascular events (MACE) such as vascular dementia, heart attack, stroke, and death by roughly a quarter — but people who received the recombinant shingles vaccine before developing shingles saw their risks of those outcomes drop by up to half, according to a large retrospective study.
    • “Among more than 174,000 people, ages 50 or older, those who developed a herpes zoster infection were approximately 20% more likely to have a heart attack, 27% more likely to have a stroke, and up to 30% more likely to die than people who didn’t develop shingles, reported Ali Dehghani, DO, of Case Western Reserve University in Cleveland.
  • and
    • “Visceral and liver fat were tied to carotid atherosclerosis in two cohort studies using MRI and ultrasound imaging.
    • “Associations persisted even after accounting for traditional cardiovascular risk factors like cholesterol and blood pressure.
    • “Study authors encourage a healthy diet as a way reduce visceral fat and therefore manage the risk of cardiovascular disease.”
  • Per Genetic Engineering and Biotechnology News,
    • “In a new study published in Cancer Cell titled, “Tumor-infiltrating bacteria disrupt cancer epithelial cell interactions and induce cell-cycle arrest,” researchers from the University of Texas MD Anderson Cancer Center have discovered a previously unknown mechanism that explains how bacteria can drive treatment resistance in patients with oral and colorectal cancer. 
    • “While tumor-infiltrating bacteria have been known to impact cancer progression and treatment, the mechanism has been unclear. Results demonstrate how the bacteria, Fusobacterium nucleatum (Fn), can induce a reversible state, known as quiescence, in cancer epithelial cells to allow tumors to evade the immune system and resist chemotherapy. 
    • “These bacteria-tumor interactions have been hiding in plain sight, and with new technologies we can now see how microbes directly affect cancer cells, shape tumor behavior and blunt the effects of treatment,” said Susan Bullman, PhD, associate professor of Immunology and associate member of MD Anderson’s James P. Allison Institute and corresponding author of the study. “It’s a whole layer of tumor biology we’ve been missing and one we can now start to target. We hope these findings help open the door to designing smarter, microbe-aware therapies that could make even the toughest cancers more treatable.” 

From the HLTH Conference,

  • Modern Healthcare tells us,
  • Healthcare Dive informs us,
    • “Online pharmacy Cost Plus Drugs will be participating in President Donald Trump’s drug price transparency tool, TrumpRx, according to Cost Plus’ founder Mark Cuban.
    • “Cuban shared the news during his keynote at the HLTH conference on Sunday, during which the billionaire entrepreneur and pharmacy disruptor also excoriated the pharmacy benefit manager industry for driving up the cost of U.S. medications.”
  • Per Fierce Healthcare,
    • “At the 2025 HLTH conference in Las Vegas, GE HealthCare unveiled health system partnerships and the latest research projects that are part of its AI Innovation Lab. 
    • “The company is working with the Queen’s Health Systems in Honolulu and Duke Health in Durham to advance the development of its new AI-driven hospital operations software, which will become part of CareIntellect.
    • “CareIntellect, a generative AI platform, is a hub for various GE HealthCare applications and was first announced at HLTH last year. The idea is to enable health systems to easily deploy new applications without a product-by-product integration approach. 
    • “Now you can really have a common data layer, that’s all the data is structured in a way that you can analyze and plug into. You can bring more applications, whether that’s on the operations side, on the care delivery side,” Taha Kass-Hout, GE HealthCare’s global chief science and tech officer, told Fierce Healthcare.”
  • and
    • WeightWatchers is joining forces with Amazon Pharmacy to make it easier for members to access weight management medications.
    • The company announced Monday that through the partnership its members will be able to access information on real-time medication availability, automated coupon savings and home delivery for key medications they use to manage their weight.
    • Amazon Pharmacy will automatically apply coupons for members at the point of checkout, according to an announcement, without the need to submit codes manually. Amazon Prime members have access to two-day home delivery, and in certain locations same-day delivery is available as an option.
    • Scott Honken, chief commercial officer for WeightWatchers, told Fierce Healthcare that the team has had a longstanding relationship with Amazon, but tapping into its pharmacy unit made sense as it looked to improve access and ease for members.
  • and
    • “Artificial intelligence startup OpenEvidence banked $200 million in series C funding, just three months after it raised $210 million in a series B.
    • “The three-year-old company’s valuation hit $6 billion post-series C raise, Daniel Nadler, Ph.D., one of OpenEvidence’s founders confirmed to Fierce Healthcare on Monday. OpenEvidence developed an AI-powered medical search engine and generative AI chatbot exclusively for doctors that summarizes and simplifies evidence-based medical information. 
    • “The New York Times first reported the series C funding Monday morning.
    • “OpenEvidence has raised nearly $500 million since its founding in 2022. Google Ventures led the round. Existing investors Sequoia, Kleiner Perkins, Thrive and Coatue backed the series C. New investors BOND (Mary Meeker), Blackstone and Craft also joined the round.
    • “The company offers its chatbot to physicians for free, and the product has grown organically through word of mouth between doctors, Nadler said.
    • “OpenEvidence plans to use the fresh funding to continue building out its AI technology.”
  • and
    • “Highmark is teaming up with Noom to roll out its weight management solution to members.
    • “Eligible members can enroll in the program and will receive Noom’s services at no cost. Their care journeys can be personalized to meet their individual needs and generally follow three tracks: weight loss and management, diabetes prevention and management.
    • “Maria Baker, vice president for health strategy and delivery at Highmark, told Fierce Healthcare that the partnership with Noom reflects the insurer’s broader commitment to whole-person health, as a holistic weight management program is a logical place to start filling in key gaps in members’ experiences.
    • “The healthcare industry can forever try to make people come to us and think about our language, or we can meet people where they are,” she said. “And one of the best ways to do that is to meet people in a language they understand, and through a door that people are always talking about.
    • “So the weight journey was the most logical place to start,” Baker said.”
  • and
    • “Knownwell picked up $25 million in fresh funding, riding the wave of investment in obesity care.
    • “CVS Health Ventures led the round with participation from MassMutual Catalyst Fund and Intermountain Ventures.
    • “Existing investors a16z Bio + Health and Flare Capital Partners also backed the oversubscribed financing round. The company has raised a total of $50 million to date, with a $20 million round in late 2023.
    • “The startup offers in-person and virtual services as a weight-inclusive primary care and metabolic health company. Knownwell offers broader services beyond just weight management or GLP-1 prescriptions to include nutrition counseling and behavioral health services both online and in person.”

From the U.S. healthcare business front,

  • Beckers Oncology notes,
    • “Philadelphia-based Penn Medicine and Penn Medicine Princeton (N.J.) Health will break ground on a $401 million cancer center Oct. 20 at the Princeton Medical Center in Plainsboro, N.J.
    • “The Penn Medicine Princeton Cancer Center is expected to open in May 2028, according to a Penn Medicine news release.
    • “The center will house more than 40 exam rooms, 30 infusion chairs, two linear accelerators for radiation therapy and a breast imaging center.
    • “Care teams at the cancer center will work with experts from the Penn Medicine Abramson Cancer Center. Patients will also have access to clinical trials and services such as proton therapy and personalized cell therapies through other Penn Medicine care sites, the release said.”
  • Per Fierce Pharma,
    • “Merck has kicked off construction of a new $3 billion facility at its sprawling manufacturing campus in Elkton, Virginia. The investment is part of the New Jersey company’s plan to spend more than $70 billion on manufacturing, R&D and capital projects in the U.S., it announced Monday.
    • “The planned 400,000-square-foot facility will add to Merck’s presence at the massive site at the base of the Blue Ridge Mountains in Virginia’s Shenandoah Valley. The complex already covers 1.2 million square feet and employs more than 1,000.
    • “With the investment spanning active pharmaceutical ingredient and drug product functions, the new plant will support small-molecule production and testing, Merck said. The facility, dubbed as its Center of Excellence for small-molecule manufacturing, could create more than 500 full-time jobs, according to the company.”
  • Modern Healthcare relates,
    • “Hartford HealthCare said Monday it won a bid to purchase two Connecticut hospitals from bankrupt Prospect Medical Holdings. The deal, which is subject to court approval, involves Manchester Memorial Hospital and Rockville General Hospital.” 
  • and
    • “Humata Health will provide its prior authorization automation tool through Microsoft’s generative artificial intelligence assistant, Dragon Copilot.
    • “Microsoft launched Dragon Copilot in March to assist clinicians with documentation, revenue cycle management, patient engagement and decision support. 
    • “The integration will enable clinicians to automate and complete prior authorizations within their workflows, a Humata spokesperson said Monday. Microsoft will determine when the tool will be available through Dragon Copilot, and Humata is discussing the capability with customers, the spokesperson said.”
  • BioPharma Dive lets us know,
    • “The share price of Alto Neuroscience more than doubled at one point Monday, after the psychiatry drug specialist announced plans to hasten the development of a potential depression medicine.
    • “This medicine, code-named ALTO-207, combines a drug already used to treat Parkinson’s disease with the active ingredient in the nausea medication Zofran. Alto got ahold of ALTO-207 this spring, when, for less than $2 million, it bought a slate of experimental, dopamine-boosting drugs from Chase Therapeutics. In unveiling that deal, Alto said it intends to start, by the middle of next year, a mid-stage clinical trial that could serve as the foundation for ALTO-207 getting approved in treatment-resistant depression.
    • “Now, encouraged by a recent meeting with the Food and Drug Administration, the company also wants to initiate a late-stage study by early 2027.”
  • Per Fierce Healthcare,
    • “Humana and Providence on Monday unveiled a new data exchange partnership the major payer and provider said could become a blueprint for the broader industry.
    • “The data sharing ecosystem is slated to go live later this month in an initial rollout focused on automating member attribution for Humana Medicare Advantage members, which the companies said will help the 51-hospital system’s providers understand which patients are considered by Humana to be under their care.
    • “Additional capabilities on the data exchange collaboration’s road map will focus on reducing administrative burden and bolstering clinical decision-making, they said.
    • “The healthcare industry is overwhelmed by fragmented, inconsistent data formats that make care coordination costly and slow,” Michael Westover, vice president of population health informatics at Providence, said in the announcement. “Because we want to be successful in value-based care contracts, Humana and Providence are building a shared foundation of administrative, financial and clinical data using national standards and modern technology.”
    • “More specifically, the pair said they’re using HL7 Fast Healthcare Interoperability Resources (FHIR), Da Vinci Project Implementation Guides and other “modern” application programming interfaces (APIs) to build out their infrastructure.
    • “That framework “will be easily replicable, serving as a scalable model that can transform care across the healthcare industry,” they said.”
  • Per an Institute of Clinical and Economic Review news release,
    • “Today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions. * * *
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on November 17, 2025.” 

Friday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, HSA, Medical / Rx research, No Surprises Act, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • The American Hospital News lets us know,
    • “The Senate Oct. 16 failed for a 10th time to advance the continuing resolution to extend government funding and end the ongoing shutdown. The chamber adjourned until Oct. 20, pushing the shutdown into next week. The House continues to remain out of session with no plans to return. Lawmakers remain at an impasse, and no formal negotiations have resumed.”
  • Govexec informs us,
    • “President Trump on Wednesday signed a new executive order effectively indefinitely extending the ongoing hiring freeze, albeit while creating new requirements for federal agencies to obtain exceptions as well as new opportunities to politicize the federal workforce.
    • “Trump’s hiring freeze, first implemented on Jan. 20, was set to expire Wednesday. The new order, entitled Ensuring Continued Accountability in Federal Hiring, requires agencies to create a strategic hiring committee, whose membership should include the deputy agency head and the agency head’s chief of staff, to approve “the creation or filling” of each vacancy within the organization. It also requires the creation and submission to both the Office of Personnel Management and the Office of Management and Budget of an annual staffing plan.
    • “In these plans, agencies shall seek to improve operational efficiency; eliminate duplicative or unnecessary functions and positions; reduce unnecessary or low-value contractor positions; promote employee accountability; enhance delivery of essential service; appropriately prioritize hiring for national security, homeland security and public safety positions; and implement the recruitment initiatives described in the merit hiring plan,” the order states. “Going forward, agencies shall prepare, in coordination with OPM and OMB, annual staffing plans to implement at the start of each new fiscal year.”
  • OPM Director Scott Kupor discusses the new executive order in this week’s post in his Secrets of OPM blog.
    • “The goal of this exercise is not for OPM nor OMB to question the judgment of our very capable agency heads; without a doubt, the “CEOs” of these organizations know their agencies far better than do we. Rather, the goal is to provide a level of pan-government visibility across resourcing in furtherance of the key initiatives that the president has laid out. And, in doing so, we can look for ways to maximize efficiency and deliver the best possible set of services to the American people.
    • “For example, if we learn that collectively across agencies we are looking to hire 10,000 engineers this year, then OPM can help design an x-government process to facilitate more centralized hiring. Or, if we see that there are core personnel resources that are being duplicated across agencies that could be more effectively done via specialization and centralization, OPM can help drive that as well. And this list goes on.
    • “None of this is rocket science. But President Trump rightfully recognizes that the federal government needs to operate on the same fundamental practices that do all modern organizations writ large.
    • “Rationality prevails – at least for now – in DC.”   
  • 401k Specialist points out,
    • “Assets in health savings accounts (HSAs) climbed to $146 billion in 2024, with an 18% year-over-year increase, according to new data out today from Morningstar.
    • “The investment analyst’s latest Health Savings Account Landscape Report notes that the tax benefits associated with HSAs, along with widespread adoption of high-deductible health plans (HDHPs), has accelerated growth among the savings vehicles.
    • “Growing adoption of HDHPs has coincided with HSA asset growth, Morningstar reports. According to the findings, the percentage of workers in employer-sponsored medical insurance plans that have elected HDHPs increased from 7% in 2006 to 32% by the end of 2024. In that same timeframe, HSA assets rose to $146 billion from close to $5 billion about 20 years ago.
    • “In nearly a decade of research, we’ve seen the HSA industry mature considerably as more individuals take advantage of the powerful tax advantages and long-term savings potential these accounts offer,” said Greg Carlson, senior manager research analyst at Morningstar, in a statement.”
  • Fierce Healthcare relates,
    • “A new evidence-based framework aims to establish a U.S. industry standard for measuring health equity efforts.
    • “Put out by the Institute for Healthcare Improvement (IHI), the white paper has been in the works for two years. It offers a four-step approach to help healthcare teams across settings identify health disparities. Advancing health equity is defined in the paper as reducing and eliminating health disparities that adversely affect historically underserved groups.
    • “We’re hoping that this will be a standardized approach to data and measurement,” Nikki Tennermann, IHI senior project director and an author of the white paper, told Fierce Healthcare. “We wanted to make sure that this framework was accessible to big large integrated health systems but also maybe it’s a small local mental health alliance.”
    • “In healthcare, there is no single standard to identify, quantify, track and report health equity gaps in patients, per the paper. The framework aims to address that. More than 35 subject-matter experts representing clinical, quality, payer, academic and administrative roles contributed to the framework.”  
  • Fierce Pharma notes,
    • “Six years since the FDA blessed Sanofi and Regeneron’s Dupixent as the first biologic to treat chronic rhinosinusitis with nasal polyps (CRSwNP), a second biologic therapy has broken through with a nod in the indication.
    • The U.S. regulator has endorsed Amgen and AstraZeneca’s Tezspire as an add-on maintenance treatment for patients age 12 and older. The first-in-class monoclonal antibody, which is injected monthly, inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine which triggers inflammation.
    • It’s this novel mechanism of action that keys the effectiveness of Tezspire, which has produced clinical results that suggest it could become the top product on the market for CRSwNP.”

From the judicial front,

  • Govexec reports,
    • “The Trump administration on Friday vowed to comply with a judge’s order to halt any layoffs caught up in a court-ordered pause on such reductions, though it left the door open to cuts of personnel not currently party to the lawsuit.” * * *
    • “The plaintiffs on Friday filed an amended complaint seeking to add the National Federation of Federal Employees, the National Association of Government Employees and the Service Employees International Union to the case to ensure protection for those workers as well. In an emergency an emergency hearing for Friday evening, the judge on the case agreed to expand her order to include those employees.”  
  • Beckers Payer Issues relates,
    • “Wellmark Blue Cross and Blue Shield has filed a lawsuit against Iowa’s insurance commissioner, challenging the enforcement of a newly enacted state law that regulates pharmacy benefit managers and the administration of prescription drug benefits.
    • “The lawsuit, filed on Oct. 14 in an Iowa federal court, claims that the legislation violates the First Amendment and the Employee Retirement Income Security Act. The lawsuit stems from the Iowa court’s previous ruling in a case involving the Iowa Association of Business and Industry, which had sought to block the bill, and a ruling in July that partially found the law to be invalid.
    • “While the court granted a preliminary injunction in that case and blocked the law’s enforcement against certain plaintiffs, Wellmark argues that the injunction does not extend to other entities like itself, which were not part of the previous lawsuit. Wellmark claims that the enforcement of the new law would harm its business and members by imposing significant costs and regulatory burdens, especially those tied to provisions the court previously found unconstitutional, including anti-referral and anti-promotion requirements for pharmacies and PBMs.
    • “The complaint also argues that many provisions of the law violate ERISA’s preemption provisions and impose regulations that interfere with the administration of ERISA plans. Wellmark has requested an injunction to block enforcement of the provisions that have been enjoined in the other lawsuit, as well as additional provisions that affect its role in administering ERISA-covered plans.” 
  • The Miller & Chevalier law firm observes,
    • “Air ambulance providers Guardian Flight, LLC, and Med-Trans Corporation, both of whom lost their bids to sue payors in court for payment of No Surprises Act (NSA) Independent Dispute Resolution (IDR) determinations, petitioned the U.S. Supreme Court on October 8, 2025, seeking to overturn a Fifth Circuit decision finding no private right of action under the NSA. Guardian Flight, L.L.C., et al. v Health Care Service Corporation, No. 25-441 (U.S.).” * * *
    • “The majority of federal courts that have addressed the issue of whether the NSA provides a private right of action have decided it does not and the Fifth Circuit is the only federal appellate court to rule on this issue. Without a circuit split, it will be surprising if the Court takes up this issue at this time.” 

From the public health and medical / Rx research front,

  • Per the University of Minnesota’s CIDRAP,
    • “In a precursor to what we might expect in the coming flu season in the United States and across the Northern Hemisphere, a new study shows flu vaccine effectiveness (VE) to be around 50% for both clinic visits and hospital stays for influenza during the 2025 Southern Hemisphere flu season.
    • “The findings, which demonstrate that the vaccine cuts the rate of medical care for flu in half, were published recently in Morbidity and Mortality Weekly Report by researchers with the US Centers for Disease Control and Prevention (CDC), the Pan American Health Organization, and their collaborators in Southern Hemisphere nations.
    • “CDC recommends that all eligible persons aged ≥6 months receive the seasonal influenza vaccine,” the authors note. “The 2025–26 Northern Hemisphere seasonal influenza vaccine composition is the same as that used during the 2025 Southern Hemisphere influenza season and might be similarly effective if the same viruses circulate in the coming season.”
  • Beckers Clinical Leadership tells us,
    • “U.S. adult obesity prevalence has dipped slightly year over year, with fewer states reporting obesity rates at or above 35%. However, the nation continues to face a high overall obesity rate.
    • “That’s according to a new report released Oct. 16 by Trust for America’s Health.
    • “Nineteen states had adult obesity rates at or above 35% last year, down from 23 in 2023, according to “The State of Obesity: 2025,” which is based in part on TFAH’s analysis of 2024 CDC data, and recent data from the 2021-2023 “National Health and Nutrition Examination Survey.”
    • “Still, the analysis found that slightly more than 4 in 10 U.S. adults have obesity, and rates are rising among children and adolescents, with more than 21% of those ages 2 to 19 affected.”
  • Health Day adds,
    • “A new definition of obesity could dramatically increase the number of Americans considered obese.
    • “Under the new definition, the prevalence of obesity rose from around 40% to nearly 70% among more than 300,000 people participating in a long-term health study, researchers reported Oct. 15 in JAMA Network Open.
    • “The new definition takes into account additional measures of excess body fat rather than just relying on body mass index (BMI). BMI is an estimate of body fat based on height and weight.
    • “We already thought we had an obesity epidemic, but this is astounding,” said co-lead researcher Dr. Lindsay Fourman, an endocrinologist at Mass General Brigham in Boston.
    • “With potentially 70% of the adult population now considered to have excess fat, we need to better understand what treatment approaches to prioritize,” she said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “The gut microbiome has been increasingly connected to a myriad of conditions, in part due to the metabolic output of the microbes in the gut. Studies have suggested that exposure to carcinogens or toxins can have a broader impact on health. The brain-gut microbiome connection has also been under investigation. How the gut microbiome impacts the brain’s response to and preference for alcohol has not yet been thoroughly explored.
    • “Researchers at Tufts University have found a connection between a gut fungus, Candida albicans, and the dopamine pathway in the brain. Their paper titled, “Candida albicans colonization modulates murine ethanol consumption and behavioral responses through elevation of serum prostaglandin E2 and impact on the striatal dopamine system,” was published in mBio.” * * *
    • “While many treatments for alcohol use disorder hinge on behavioral modifications, exploration of alternative approaches, including therapies involving the gut microbiome, may be a promising path. “We are excited to learn more about the mechanisms that allow microbes to affect host behavior,” shared [the researchers] Kumamoto and Day with GEN.” 
  • and
    • “Faulty brain circuits seen in Down syndrome may be caused by the lack of a particular molecule essential for the development and function of the nervous system, according to a new study in lab mice. Restoring the molecule, called pleiotrophin, could improve brain function in Down syndrome and other neurological diseases, possibly even in adults, the researchers say.
    • “The scientists conducted their work in mice, rather than in people, so the approach is far from being available as a treatment. But the researchers found that administering pleiotrophin improved brain function in adult mice long after the brain was fully formed. That suggests that the approach could offer major advantages over prior attempts to enhance Down syndrome brain circuits that would have required intervention at extremely precise, and brief, times during pregnancy.
    • “This study is exciting because it serves as proof-of-concept that we can target astrocytes, a cell type in the brain specialized for secreting synapse-modulating molecules, to rewire the brain circuity at adult ages,” said researcher Ashley N. Brandebura, PhD, who was part of the research team while at the Salk Institute for Biological Studies and is now part of the University of Virginia School of Medicine. “This is still far off from use in humans, but it gives us hope that secreted molecules can be delivered with effective gene therapies or potentially protein infusions to improve quality of life in Down syndrome.”
  • The Wall Street Journal reports on human longevity research focused on people living beyond 110 years.
    • “Supercentenarians, a rare group of people older than 110, are tracked and their ages validated by an international nonprofit known as the Gerontology Research Group. Two hundred or so are alive today, the eldest now being a 116-year-old British woman.”
  • Per Radiology Business,
    • “One New York organization recently detailed how it was able to more than double the number of eligible patients who complete lung cancer screenings. 
    • “Over a decade after the U.S. Preventive Services Task Force (USPSTF) recommended lung cancer screening (LCS) in high-risk individuals via low-dose CT scans, utilization of the exam has continued to lag. Less than 20% of eligible patients in the U.S. adhere to LCS recommendations, despite numerous studies highlighting the exam’s ability to spot cancer at its earliest stages. 
    • “A group of providers from the University of Rochester Medical Center (URMC) were able to overcome this statistic, increasing their organization’s LCS rates from 33% in 2022 to 72% in 2025, sharing their findings in the New England Journal of Medicine Catalyst.   
    • “Our biggest success was not only screening a high percentage of eligible patients, but also enrolling those patients in the comprehensive program to ensure they receive the necessary annual follow-up screenings,” noted lead author Robert Fortuna, MD, MPH, professor of primary care and pediatrics at URMC.”

From the U.S. healthcare business front,

  • Beckers Clinical Leadership reports,
    • “Productivity, rather than quality, is gaining prominence in physician bonus structures, according to a recent report from recruiting firm AMN Healthcare. 
    • “Last year, 62% of physician contracts featured a production bonus, the report found. That figure has grown to 66%. In comparison, 16% of contracts included a quality metric in its bonus structure, down from 26% in 2024 and 31% in 2023. 
    • “Productivity metrics include relative value units, net collections, gross billings and patient encounters. Quality ranges from patient satisfaction scores to readmission rates, according to the report. 
    • “Despite initiatives “to steer physician payments toward quality metrics and away from volume-based formulas,” according to the report, “finding the right compensation formula … has been elusive.”
    • “Other industry reports have found a similar trend, with base salary and work RVU productivity remaining the most common aspect of physician compensation plans.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical introduced a pay-per-visit telehealth service for common pediatric conditions like pink eye, skin rashes and asthma prescription medication renewals.
    • “The service offers parents and guardians virtual consultations and expert medical advice for select children’s care needs, Amazon executives said in a blog post.
    • “The telehealth service, available for children ages 2 to 11, can help treat pink eye, lice and more than 10 common skin-related issues such as eczema; bug bites; contact dermatitis; impetigo; fungal rashes (e.g., ringworm); hand, foot and mouth disease; fifth disease; roseola; poison ivy; and diaper rash. This service also covers EpiPen and asthma medication renewals. For any prescriptions that are needed, customers can fulfill those orders through Amazon Pharmacy or the pharmacy of their choice. 
    • “Message-based visits start at $29, and video consultations cost $49. Insurance, Prime memberships or Amazon One Medical memberships are not required to use the service.”
  • and
    • “With the launch of its first direct-to-patient (DTP) program, Genentech is joining the wave of drugmakers setting up direct-to-consumer sales of popular products at steep discounts for cash-paying patients.
    • “The Roche subsidiary’s inaugural DTP program will center on Xofluza, its prescription influenza treatment, according to Thursday’s announcement. The single-dose oral antiviral med will be available to eligible uninsured, underinsured and self-pay patients for $50, down about 70% from its list price, per Genentech.
    • “The program will fulfill Xofluza prescriptions via partnerships with a trio of online pharmacies: Alto Pharmacy, Amazon Pharmacy and Mark Cuban Cost Plus Drug Company. Same-day delivery will be available in some U.S. markets through Alto Pharmacy and Amazon Pharmacy.
    • “The new DTC approach to Xofluza sales “will allow us to reach more patients where they are increasingly interested in seeking their medicines,” Genentech CEO Ashley Magargee said in the announcement.”

Thursday Report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Republicans and Democrats both see a likely path to ending the government shutdown, involving extending enhanced Affordable Care Act healthcare subsidies for a year or longer. But there are a series of reasons why no deal has emerged, even with costs set to surge for more than 20 million Americans.
    • “The shutdown is now entering its third full week, with no serious talks under way. The House passed its short-term bill to fund the government through Nov. 21 and has been out of town since. Democrats have repeatedly blocked the measure in the Senate, where Republicans have a 53-47 majority, but 60 votes are required to advance the legislation.”
  • Per a Senate news release,
    • “Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and John Hickenlooper (D-CO) introduced the 21st Century Dyslexia Act, legislation that incorporates the modern, scientific understanding of dyslexia into federal statute and prevents the harm unidentified dyslexia can inflict on young students.
    • “Despite dyslexia impacting one in five Americans, students are rarely tested,” said Dr. Cassidy. “This legislation brings a common-sense approach to dyslexia, ensuring students have the resources they need to reach their full potential.”
    • “Better early screening, more awareness, and modern tools will help make sure kids with dyslexia are diagnosed early. These resources are inexpensive and immensely valuable. I know – I lived it,” said Senator Hickenlooper.
    • “U.S. Representatives Erin Houchin (R-IN), Julia Brownley (D-CA), and Bruce Westerman (R-IN) introduced the companion legislation in the U.S. House of Representatives.” * * *
    • “Read the full bill text here.”
  • Tammy Flanagan, writing in Govexec, explains “what to know when your child ages out of federal health coverage. Children can stay on a parent’s FEHB or PSHB plan until 26, but understanding the 31-day extension, conversion options and Temporary Continuation of Coverage is key to avoiding gaps.” The FEHBlog’s advice is to move your adult child to their employer sponsored health plan which should be a snap.
  • FedWeek tells us,
    • “An inspector general report has cited some positives for USPS finances but also notes that its financial picture in recent years has benefitted from several special infusions of funding from Congress that it called “unique events.” * * *
    • “First Class mail volume “is not expected to return to levels previously seen in the early part of the 20th century,” it said, and “ultimately, future retirement obligations will need to be funded.”
    • “Eliminating the prefunding requirement temporarily alleviated the Postal Service’s financial burden but did not change the fact that once the [Postal Service Retiree Health Benefits Fund] runs out of funds, the Postal Service is responsible for funding its share of the healthcare premium costs for its retirees as the costs are incurred,” it said.”
  • Per a Labor Department news release,
    • “U.S. Secretary of Labor Lori Chavez-DeRemer today joined President Trump at the White House as the President announced the third most-favored-nation agreement, which will result in significant cost savings on fertility treatments. On the heels of the President’s announcement, the U.S. Department of Labor, joined by the Departments of Health and Human Services and Treasury, issued guidance designed to cut burdensome red tape, helping employers understand how to structure health benefits to expand access to fertility treatments like In Vitro Fertilization or IVF.” * * *
    • “Following the President’s announcement today, the Departments of Labor, Health and Human Services, and Treasury issued new guidance in line with the President’s Executive Order 14216, “Expanding Access to In Vitro Fertilization.” The guidance clarifies existing categories of excepted benefits that employers can use to offer fertility benefits, including fertility treatment through a specified disease or illness policy, or offering reimbursement for those services through an excepted benefits health reimbursement arrangement.
    • “The departments also intend to propose rulemaking aimed at providing additional ways that certain fertility benefits may be offered as a limited excepted benefit. The departments are also considering whether to modify the standards under which supplemental health insurance coverage provided by a group health plan, including a supplemental benefit for fertility coverage, will be considered to satisfy the conditions for being an excepted benefit.”
  • According to a Paragon Health Institute report,
    • “The Inflation Reduction Act caused Medicare Part D stand-alone prescription drug plan premiums to increase nearly 600 percent from 2023 to 2026.
    • “To disguise this premium spike, the Biden administration abused Medicare’s “demonstration” authority. Despite the Biden administration’s $5 billion bailout of the Inflation Reduction Act’s failed policies, the number of plans declined by over half from 2021 to 2025.
    • “The Trump administration has sensibly mitigated this abuse, phased down the bailout, and reduced distortions in the Medicare Part D program.”
  • The Postal Service Health Benefits Program relies heavily on stand-alone Medicare Part D prescription drug plan for benefit cost savings.

From the Food and Drug Administration front,

  • Per an HHS press release,
    • “The U.S. Food and Drug Administration today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.
    • “Voucher recipients will receive a decision within 1-2 months following filing of a complete application for a drug or biologic. In addition, sponsors will receive enhanced communications with review staff throughout the development process prior to their final submission and during the review period. If necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they otherwise deem appropriate.” * * *
    • “The following products were selected:
      • “Pergoveris for infertility
      • “Teplizumab for Type I diabetes
      • “Cytisinicline for nicotine vaping addiction
      • “DB-OTO for deafness
      • “Cenegermin-bkbj for blindness
      • “RMC-6236 for pancreatic cancer
      • “Bitopertin for porphyria
      • “Ketamine for domestic manufacturing of a critical drug for general anesthesia
      • “Augmentin XR for domestic manufacturing of a common antibiotic.”
  • Per MedPage Today,
    • “The FDA is warning about the potential for serious injuries with radiofrequency (RF) microneedling for skin procedures following reports of burns, scarring, disfigurement, and nerve damage.
    • “The agency said it is working with manufacturers of the class II medical devices with the hopes of identifying mitigation strategies. “While the FDA’s evaluation is ongoing, we are asking patients, caregivers, and healthcare providers to report any complications to the use of these devices for dermatologic or aesthetic skin procedures.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “The first US case of locally acquired clade 1 mpox has been reported in Long Beach, California, according to city and state health authorities.
    • “The clade 1 case is the nation’s first in a person with no recent travel history and the seventh clade 1 case in the country. The patient required hospitalization and is now isolating and recovering at home, the City of Long Beach news release said.
    • “Public health officials are reviewing the patient’s potential source of exposure and conducting contact tracing. No other cases have been identified.
    • “While the overall risk of mpox clade I exposure to the public remains low, we are taking this very seriously and ensuring our community and health care partners remain vigilant so we can prevent any more cases,” Long Beach Mayor Rex Richardson said in the release. “This underscores the importance of continued surveillance, early response, and vaccination.”
  • The New York Times reports,
    • “A study, published in the journal JAMA Ophthalmology, analyzed the number of eye injuries that brought pickleball players to hospital emergency rooms from 2005 to 2024. Dr. Tsui and his colleagues extrapolated from a database of injuries that relies on a nationally representative sample of hospitals.” * * *
    • “While there were just over 3,100 pickleball-related eye injuries that brought players to emergency rooms between 2014 and 2024, over one-third of them — some 1,262 injuries — occurred in 2024 alone.
    • “Players 50 and older, who were more likely to sustain ocular injuries than younger players, accounted for 70 percent of all eye injuries. Age-related decreases in muscle mass, bone density and balance may have made them more vulnerable, the authors said.” * * *
    • “Eye protection is not required for professional or casual play, the authors of the study noted. USA Pickleball, the sport’s governing body in the United States, last year disapproved of a rule change that would require players to wear eye protection in its tournaments, saying it would be difficult to enforce.
    • “Pickleball clubs and courts also do not require eye protection. But the American Academy of Ophthalmology last year recommended players wear eyewear that meets the American Society for Testing and Materials F3164 guidelines, which are the standard for most racket sports.”
  • United Healthcare, writing in LinkedIn, ponders whether GLP-1 drugs are real-life wonder drugs.
    • “GLP-1 drug sales are up 500% since 2018, with growth accelerating as new uses emerge.
    • “Beyond diabetes and obesity, they show promise for Alzheimer’s, cancer and more.
    • ‘GLP-1 users also saw a 44% drop in hospitalizations from stroke, heart attack and heart failure.”
  • The Genetic Engineering and Biotechnology News relates,
    • “Although it well known that the human gut contains a large and diverse array of bacteriophages, a functional understanding of the phage–host interactions is limited. This is, in part, due to a lack of cultured isolates available. Now, a new study uncovers hundreds of new phages within our gut, information that could eventually reshape the gut microbiome, potentially influencing gut health and the progression of various disease states.
    • “Published in Nature in the paper, “Isolation, engineering and ecology of temperate phages from the human gut,” the study is the first of its kind and uses a large-scale, culture-based approach to isolate and study temperate bacteriophages in the human gut.
    • “This is a foundational study that changes how we think about and study the viruses within the human gut,” said Jeremy Barr, PhD, professor at the Monash University’s School of Biological Sciences. “We found that compounds produced in human gut cells can wake up dormant viruses inside gut bacteria. This could have major implications for gut diseases like inflammatory bowel disease (IBD), where inflammation and cell death are common.”
  • Per MedPage Today,
    • “There were 176.6 major congenital malformations (MCMs) per 10,000 infants exposed to first-trimester COVID-19 mRNA vaccines, compared with 179.4 per 10,000 infants not exposed to the vaccines.
    • “There were no associations between mRNA vaccine exposure and MCMs by organ system.
    • “There was no difference in the rate of stillbirths between pregnant women who received mRNA vaccines and those who didn’t (both 0.4%).”
  • Per BioPharma Dive,
    • “A regimen pairing Johnson & Johnson’s dual-pronged multiple myeloma drug Tecvayli with an older medication, Darzalex, staved off disease progression and death better than Darzalex and a standard drug combination in a Phase 3 trial, the company said Thursday.
    • “According to J&J, a panel of independent trial monitors recommended halting the study early after the Tecvayli regimen met its objectives at an early data check. Researchers have been following trial volunteers for an average of about three years.
    • “The trial assessed the Tecvayli combination in people whose multiple myeloma had progressed after one to three prior treatment lines. Tecvayli is currently available to patients who’ve previously received at least four lines of care. That clearance, awarded in 2022, was an “accelerated” approval, which requires confirmation from a trial that demonstrates a survival benefit.”
  • and
    • “Final results from a years-long study show that Novartis’ Fabhalta medicine can significantly slow the decline of kidney function in patients with IgA nephropathy, the Swiss drugmaker said Thursday.
    • “The trial, known as Applause-IgAN, compared twice-daily doses of Fabhalta with a placebo in patients with the rare kidney disease. After two years of treatment, researchers found that the patients on Fabhalta had significantly better results on a scale that measures how well kidneys filter waste from the blood.
    • “Fabhalta had already won accelerated approval from the Food and Drug Administration in 2024 based on initial data showing the drug could reduce protein in the urine of patients with the condition. With the final study results in hand, Novartis now plans to seek a full, traditional approval of the medicine for IgAN patients next year.”
  • and
    • “In March 2023, investors could buy a share of Praxis Precision Medicines for about the same price as a dollar-menu item at a fast-food restaurant. The Boston-based biotechnology company had just suffered a major setback with one of its experimental medicines, which failed a key study testing it as a treatment for a neurological disease that causes involuntary shaking.
    • “Praxis, as drug companies often do, found enough silver linings in the data to push its medicine forward. The company consulted with the Food and Drug Administration that summer and began enrolling two late-stage trials that fall. By February 2025, a group of independent experts were telling Praxis the first of those trials looked unlikely to succeed. It decided to continue anyway.
    • “That confidence appears to have paid off, as Praxis on Thursday disclosed that both of its studies met their main goals. The company now plans to submit an approval application to the FDA by early 2026. Its share value, which got buffed in late 2023 from a 1:15 stock split, more than tripled on the announcement, peaking at $200 Thursday afternoon.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • ‘New York City-based Montefiore Health System and Garnet Health have signed a letter of intent for Garnet to join the academic health system through a strategic affiliation. 
    • “Garnet Health, a three-hospital system headquartered in Middletown, N.Y., serves more than 500,000 residents across New York’s mid-Hudson and Catskills regions.
    • “The proposed transaction would expand Montefiore’s presence in the Hudson Valley and strengthen Garnet Health’s clinical services, specialty care offerings and long-term sustainability.
    • “Montefiore, which operates 10 hospitals and more than 200 outpatient sites, described the deal as a natural fit.”
  • and
    •  “Already-strained emergency departments are not only projected to experience more volume in the near future, but also more clinical cases requiring immediate attention, according to a Vizient Sg2 report published Oct. 15.
    • “Vizient, which works with hundreds of U.S. hospitals and other healthcare providers, estimates a 5% increase in ED visits between 2025 and 2035. Urgent visits are projected to remain stagnant while emergent cases — those requiring immediate action — are expected to rise 8% over the decade. 
    • “Over the past year, emergent visits increased 6% while urgent visits stabilized. Sixty-five percent of ED visits between the third quarter of 2024 and the second quarter of 2025 were emergent. 
    • “While urgent visits have stabilized, continued efforts to redirect low-acuity patients to alternative care sites remain essential to improving ED throughput and preserving capacity for higher-acuity cases,” the report said.”
  • and
    • “Physician compensation rose more in 2025 than in any year over the past decade, largely due to clinician supply and demand imbalances, according to a survey from SullivanCotter. 
    • “Published Oct. 15, the survey is based on data from more than 500 healthcare organizations representing approximately 231,300 physicians across 232 specialties. It found that median physician total cash compensation — base salary plus incentives — grew year over year across all major specialty categories.
    • “Among those, adult medical specialties saw the largest year-over-year increase at 7.5%, as physician workforce expectations continue to evolve.”
  • Modern Healthcare discusses why private equity wants in on outpatient cardiology.
    • “Private equity investors are training their attention on cardiology — a fast-growing specialty rife with financial opportunity. 
    • “Investor interest in outpatient cardiology practices has grown in recent years, driven by a fragmented market landscape facing financial pressures and an aging population of patients and providers. The Centers for Medicare and Medicaid Services also is reimbursing more cardiac procedures in ambulatory settings, which has been an impetus for private equity firms to make investments.
    • “The growing number of transactions and operational changes hasn’t quieted skepticism about whether the investments are a win for patients. There is limited post-acquisition data on quality, patient volumes and costs of care at individual cardiology practices. The data on private equity’s overall impact on the industry paints a bleak picture.
    • “Private equity is here in cardiology. It’s not going to go away,” said Dr. Samuel Jones, director of inpatient electrophysiology at the Chattanooga Heart Institute and member of the American College of Cardiology’s Board of Trustees.”
  • Healthcare Dive points out,
    • “Prospect Medical Holdings has tentative deals to sell two of its shuttered hospitals in Pennsylvania — Chester Medical Center and Springfield Hospital — for a combined $13 million, according to documents filed to bankruptcy court last week. 
    • “Chariot Allaire Partners has offered $10 million for Crozer-Chester Medical Center, while Restorative Health Foundation and Syan Investments together have offered $3 million for Springfield Hospital.
    • “Closing the deals would allow Prospect to finally rid its hands of failed Crozer Health, following years of conflict with state regulators over its management practices and failed sales attempts. Crozer fully shuttered this spring.”

From the artificial intelligence front,

  • Healthcare Dive lets us know,
    • “Google Cloud revealed several artificial intelligence partnerships with healthcare organizations on Thursday, including for projects that summarize clinical notes and automate prior authorizations. 
    • “The partnerships come as more healthcare and life science firms are deploying AI agents, or advanced tools that can more autonomously plan and perform tasks, according to a Google Cloud survey of 605 leaders released Thursday. Forty-four percent of executives said their organizations were actively using agents, with 34% reporting they use 10 or more agents.
    • “For example, Hackensack Meridian Health built multiple AI agents using Google’s generative AI technology, including a tool that can recap patients’ medical records for doctors.
    • “The health system’s note summarization agent has helped more than 1,200 clinicians generate more than 17,000 summaries since it went live in June, according to a press release.”
  • and
    • “Microsoft is expanding its artificial intelligence-backed clinical assistant to include functionality geared towards nurses, the technology giant said Thursday. 
    • “Dragon Copilot, Microsoft’s upgraded AI assistant tool launched this spring, will be able to record nurses’ interactions with patients and help document their care, as well as access medical content or health system protocols, the company said.
    • “Microsoft collaborated with multiple health systems to build the update focused on nurses’ documentation workflow. “Physicians document very differently,” said Mary Varghese Presti, corporate vice president and chief operating officer at Microsoft Health and Life Sciences. “What we built here for nurses is not a rinse and repeat of that.” 

Columbus Day Holiday Report

David Ermer–Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

Supplementing yesterday’s Weekend Update

From Washington, DC,

  • The AP reports,
    • “President Donald Trump said Saturday that he has directed the Defense Department to use “all available funds” to ensure U.S. troops are paid Wednesday despite the government shutdown, a short-term fix that will not apply to the hundreds of thousands of federal workers who have been furloughed.
    • “Trump said in a social media post that he was acting because “our Brave Troops will miss the paychecks they are rightfully due on October 15th.”
    • ‘The Republican president’s directive removes one of the pressure points that could have forced Congress into action, likely ensuring that the shutdown — now in its 11th day and counting — extends into a third week and possibly beyond. But no similar action seems forthcoming for federal employees also working without pay while thousands are now being laid off during the lapse in government operations.”
  • Federal News Network tells us,
    • “The number of federal employees filing retirement claims in September was the lowest all year. Just over 6,300 employees submitted their retirement paperwork to the Office of Personnel Management. At the same time, OPM also processed the fewest number of current claims in September, just over 7,900. Despite the lower number of claims, OPM said it took six days longer, on average, in September than in August to process claims. The current retirement claims backlog is at 23,500, which dropped for the fourth straight month.”
  • The Washington Post interviews OPM Director Scott Kupor and others about the coming surge of retirement applications.
  • Per Beckers Payer Issues,
    • “The No Surprises Act is succeeding in protecting patients from unexpected medical bills, but insurers and provider groups remain divided on what is driving rising costs tied to the Independent Dispute Resolution process and how regulators should respond.
    • “Since the arbitration system launched in 2022, providers have won the vast majority of disputes. In 2024, they prevailed in about 85% of cases, with median payment determinations reaching 459% of the qualifying payment amount in the fourth quarter. The process has also generated at least $5 billion in costs, much of it from administrative fees and higher payments.
    • “As those costs have climbed, payers have said that the system is inflating prices across the healthcare system, while providers say it is correcting years of underpayment.
    • “The concern now is that the law hasn’t met its second objective, to contain costs,” Jennifer Jones, senior director of legislative and regulatory policy at the Blue Cross Blue Shield Association, told Becker’s. “That’s primarily because of the challenges we’re seeing with the independent dispute resolution process.”
  • The FEHBlog agrees with Ms. Jones.

From the public health and medical / Rx research front,

  • MedPage Today informs us,
    • “Among older adults who received at least one dose of the recombinant shingles vaccine, vaccine effectiveness against any herpes zoster-related outcome was 56.1%.
    • “Getting a second dose yielded a relative vaccine effectiveness of 67.9% against any herpes zoster outcome.
    • “The findings emphasize the importance of completing the full vaccination series.”
  • The Washington Post reports,
    • “The tendency to use cannabis is associated with genes linked to impulsive behavior, obesity, schizophrenia and bipolar disorder, among other traits, according to a study released Monday by researchers at the University of California at San Diego.
    • “The research, published in the journal Molecular Psychiatry, explored the genetic traits of casual and frequent cannabis users in hopes of eventually identifying medications and other therapies to treat or prevent problematic marijuana use.
    • “The study adds to a growing body of genetics research into cannabis use as policymakers and researchers weigh how to balance the benefits and consequences of the drug’s growing popularity.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Many nonprofit hospitals and health systems have made steady progress on financial turnarounds since the end of the COVID-19 pandemic — though others continue to struggle — but new and persistent challenges threaten to derail those efforts.
    • “Operating margins have inched upward across the sector, yet most remain far below the pre-pandemic “magic number” of 3%. The latest data from Strata Decision Technology shows that health system margins improved slightly to 1% in August, up from 0.9% in July, but remain relatively unchanged for the year. 
    • “While operating revenue has generally increased, it continues to be offset by rising costs — particularly in non-labor categories (such as supply and drug costs), which rose 5.7% year over year compared to a 4.6% rise in labor expenses.
    • “These pressures could intensify in the months ahead.” 
  • Beckers Payer Issues adds,
    • “When a critical patient’s prognosis is unclear, often because they are unable to wean from the ventilator, care teams begin to discuss palliative care, advance care planning, and even hospice.  Making decisions about long-term care goals can be challenging for patients and their families as they navigate the complexities of their conditions. Discussions often take place over many days while patients and families evaluate the options.  Including long-term-acute care hospital (LTACH) referral in these discussions benefits the patient for three reasons [explained in the article].

Friday report

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

From Washington DC,

  • Here is a link to today’s Secrets of OPM blog post by OPM Director Scott Kupor.
  • Here are links to Fedweek and Fedsmith articles about OPM’s 2026 government contribution announcement made yesterday.
  • Yesterday, the FEHBlog posted the Internal Revenues Service’s 2026 inflation adjusted amounts.
    • The Wall Street Journal discusses how the adjustments impact federal income taxation.
    • Newfront discusses how the adjustments impact employee benefits.
  • Healthcare Dive notes,
    • “Average Medicare Advantage star ratings for 2026 are essentially flat after a few consecutive years of declines — a good sign for the industry, which had braced itself for lower quality scores.
    • “Still, there was variation in major insurers’ results. The percentage of members in plans rated 4 stars or above, an important cutoff for payers, stayed stable for UnitedHealthcare, dropped for Humana and Aetna, and improved for Elevance and Centene — the five largest publicly traded payers in the privatized Medicare program.
    • “Perhaps the biggest loser is Clover Health. The insurer’s largest contract covering almost all of its MA members dropped below 4 stars — a slip that could cost Clover tens of millions of dollars in earnings, analysts estimate.”
  • The American Hospital Association News tells us,
    • “The federal government shutdown is expected to continue into next week as the Senate adjourned Oct. 9 after failing to pass spending legislation; senators plan to return Oct. 14. Meanwhile, the House currently has no plans to return to session next week. The Senate Oct. 9 failed to adopt the House-passed continuing resolution to fund the government following a seventh vote on the bill. Senate Republicans and Democrats have yet to begin formal negotiations toward a deal.”
  • Federal News Network points out,
    • “Hundreds of thousands of federal employees are set to receive reduced paychecks, now on day 10 of the partial government shutdown.
    • “While most civilian federal employees are expected to get their paychecks sometime in the next couple days, they’ll only take home the pay they earned up until the shutdown began. Regardless of whether they are excepted or furloughed, federal employees will not be paid for any days worked between Oct. 1 and Oct. 4 — the final few days of the most recent two-week pay period.
    • “With the partial paychecks, many federal employees will lose out on hundreds of dollars. The exact timing of when employees receive their paychecks depends on their agency, but many began going out Friday.
    • “It’s also the last paycheck excepted and furloughed employees will receive until the government shutdown ends. The first fully missed paycheck, if the shutdown continues, will be for the pay period of Oct. 5 through Oct. 18. Only federal employees who are considered “exempt” from the shutdown will continue to be paid as usual.”
  • Roll Call reports,
    • ​”The Trump administration made good on its threat to begin mass firings of federal civilian employees Friday while exploring creative avenues to make sure military personnel don’t miss their paychecks slotted to go out next week.
    • “With no end in sight to the partial government shutdown that began 10 days ago, White House budget director Russ Vought announced on X that he has begun executing mass layoffs across federal agencies.
    • “An Office of Management and Budget official said the layoffs are “substantial,” without elaborating. Details began trickling out ahead of a court-ordered deadline by close of business Friday, however, hitting numerous agencies including Treasury, EPA, Homeland Security, Education, and Housing and Urban Development, among others.
    • “Speaker Mike Johnson, R-La., meanwhile, officially canceled votes in the House next week, meaning there is virtually no chance that Congress could pass a stand-alone bill to provide pay to some 2 million troops whose next paycheck is due Oct. 15.
    • “But in keeping with President Donald Trump’s pledges to “take care of” the military while punishing “Democrat agencies,” his administration is looking at how to make sure the troops are kept whole financially. A senior White House official said the administration is “exploring every legal maneuver and option at our disposal to get our troops paid during the Democrat Shutdown.” 
  • STAT News informs us,
    • “The Senate on Thursday passed legislation that would restrict U.S. pharmaceutical and biotechnology companies from doing business with certain Chinese companies, potentially giving the president another way to pressure the industry into doing what he wants. 
    • “The BIOSECURE Act, which was passed as an amendment to the National Defense Authorization Act, has been a long time coming. A more aggressive version of the bill was introduced in the Senate in December 2023. The House proposed similar legislation the next month.
    • “BIOSECURE is not over the finish line yet, but it’s significant that the Senate included it in the National Defense Authorization Act, because the defense budget bill has passed every year for decades. The House passed its version of the defense bill earlier in the year without the BIOSECURE Act, so the two chambers would need to agree to include BIOSECURE in the final version of the defense budget bill when reconciling differences between their versions of it.”
  • The AHA News adds,
    • “The AHA discussed ways hospitals and health systems are leveraging artificial intelligence for care delivery in a statement submitted to the Senate Committee on Health, Education, Labor and Pensions for a hearing held Oct. 9 titled, “AI’s Potential to Support Patients, Workers, Children, and Families.” The AHA highlighted examples of AI applications in hospitals, such as diagnostic imaging, ambient listening tools and scheduling for patients and staff.
    • “Hospitals recognize that AI tools hold tremendous promise to alleviate administrative burden and enhance clinical care,” the AHA wrote. “Among other benefits, these innovations can improve workflow, enhance the overall patient experience by reducing wait times and support timely medical interventions.”
    • “The AHA also discussed potential risks of AI in health care, such as commercial insurers using it to determine disposition of claims and prior authorizations, which has exacerbated inappropriate denials. The AHA advocated for the use of clinicians to independently review care recommendations.”
  • The University of Minnesota’s CIDRAP relates,
    • “A federal vaccine advisory group has established a panel to review the safety and efficacy of the childhood immunization schedule, according to a document posted yesterday on the Centers for Disease Control and Prevention (CDC) website.
    • “The Childhood and Adolescent Immunization Schedule Workgroup (WG), established within the CDC’s Advisory Committee on Immunization Practices (ACIP), will review data and “clinical and scientific knowledge” and present its findings to help ACIP members make policy recommendations. 
    • “As part of ACIP’s core mission to develop recommendations on the use of vaccines in the civilian population of the United States, the committee is standing up a WG focused on assessing the safety and effectiveness of the childhood and adolescent schedule,” the document states.
    • “Among the topics the group will review are the timing and order of different childhood vaccines, administering different vaccines at the same time, the safety of certain vaccine ingredients, and the different childhood vaccine schedules used in other countries.”

From the Food and Drug Administration front,

  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved another new treatment option for heart-failure related edema. 
    • “Just weeks after its approval of bumetanide nasal spray for the treating edema associated with congestive heart failure, kidney disease and liver disease, the agency has given the greenlight to Lasix ONYU, a new drug-device combination from SQ Innovation, for adult patients with chronic heart failure. 
    • “Lasix ONYU provides patients with injections of a high-concentration formulation of furosemide. The injections are delivered with a small two-in-one device. While the base of the device is reusable, only to be replaced after 48 treatments, the other part of the device is used once and then discarded. According to SQ Innovation, this new-look design helps ensure the delivery device can be manufactured at a low enough price point so the treatment remains affordable.
    • “In one recent analysis published in European Heart Journal – Cardiovascular Pharmacotherapy, researchers found that the Lasix ONYU technology was linked to a bioavailability similar to receiving furosemide through an IV. Treatment was also confirmed to be “feasible and well tolerated.”

From the. public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention is not updating its respiratory illnesses data channel during the shutdown.
  • Dr. Tom Friden, a former CDC Director, writes in the Wall Street Journal about the simple steps that can prevent dementia.
    • “When it comes to healthy aging, personal responsibility matters. But American healthcare also suffers from systemic failures. Despite spending more than $4 trillion annually, we get the most important things, such as blood pressure control, right at most half the time. Our system doesn’t incentivize doctors to deliver the preventive care that matters most. For instance, they are paid little or nothing for making an effort to control a patient’s blood pressure.
    • “The tools for a healthy, dementia-free future exist: blood pressure control, appropriate statin and other therapy, smoking prevention and cessation support, and comprehensive primary care focused on prevention. We need a healthcare system that delivers them reliably, for all our sakes.”
  • Per Health Day,
    • “Heart-related health problems might affect as many as 1 in 7 pregnancies, even among women without any prior heart disease, a new study says.
    • “Researchers found a steady increase in heart-related health problems among more than 56,000 pregnancies between 2001 and 2019 in New England.
    • “Heart attack, stroke, heart failure, blood clots, high blood pressure and heart-related maternal death affected about 15% of pregnancies during that time, researchers reported Oct. 6 in the journal Circulation.
    • “Our findings showcase an alarming trend of rising real-world burden of pregnancy-related cardiovascular complications and highlights pregnancy from preconception to the postpartum period as a crucial window of opportunity to implement primary prevention strategies and optimize cardiovascular health,” concluded a team led by Dr. Emily Lau, a cardiologist at Massachusetts General Hospital in Boston.”
  • Per MedPage Today,
    • “New-onset atrial fibrillation (Afib or AF) was surprisingly common after coronary artery bypass grafting (CABG), but its burden quickly diminished to near zero after 30 days, according to long-term continuous ECG monitoring data.
    • “With a monitor implanted during surgery, patients at two German centers showed a 48% incidence of new-onset Afib in the first year after CABG, with a median Afib burden of 0.07% (or 370 minutes).
    • “It turned out that on days 1-7, the median Afib burden was 3.65% (368 minutes), dropping quickly thereafter to 0.04% (13 minutes) on days 8-30 and 0% (0 minutes) on days 31-365, according to researchers led by Florian Herrmann, MD, of LMU University Hospital in Munich, Germany.
    • “Although the incidence of new-onset AF after CABG in this study was higher than previously reported, the AF burden in these patients was very low, especially after 30 days,” the authors reported in JAMA.
    • “This low burden calls into question whether long-term oral anticoagulation is necessary in patients with new-onset AF after CABG. The very low burden provides a likely explanation for why observational studies have failed to demonstrate reduced stroke rates with oral anticoagulation in this patient group,” Herrmann’s group suggested.”
  • Per the American Journal of Managed Care,
    • “A smartphone app significantly reduced depressive symptoms and improved self-esteem and quality of life in individuals with intellectual disabilities.
    • “The study addressed a research gap, highlighting the app’s potential as an accessible mental health intervention for an underserved population.
    • “Limitations include self-reported data, potential bias, and lack of long-term follow-up, affecting the generalizability of results.
    • “Future research should explore optimal app use, caregiver involvement, and accessibility barriers to enhance mental health support for individuals with IDs.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “AstraZeneca is the latest major drugmaker to agree to a deal with the Trump administration on lowering the prices of its drugs, some of which will be available for purchase through a government website next year, President Trump said Friday. 
    • “The agreement, which entails offering “most-favored nation” drug pricing, follows Pfizer’s deal to reduce prices for its drugs sold in the Medicaid program and through a new direct-purchasing service to be branded TrumpRx.
    • “AstraZeneca will similarly offer all prescription drugs on the government website, TrumpRx, which the administration said it will launch in 2026, said Mehmet Oz, administrator for the Centers for Medicare & Medicaid Services.
    • “In addition to the lower drug prices for people on Medicaid, all new AstraZeneca drugs introduced to the market will be launched at most-favored nation pricing, which is tied to comparable prices in other wealthy nations.” 
  • Reuters adds,
    • “Retail pharmacies and prescription drug savings site GoodRx (GDRX.O)
      are talking with the Trump administration about joining its TrumpRx website, they told Reuters, suggesting an expansion beyond the early description of it as a link to pharmaceutical companies’ direct discounts.” * * *
    • “The National Community Pharmacists Association and the National Association of Chain Drug Stores, which represent companies like Walgreens and Costco (COST.O), said they were also talking with administration officials.”
  • The Wall Street Journal also lets us know,
    • “Johnson & Johnson JNJ is in talks to buy Protagonist Therapeutics in a deal that would solidify the companies’ existing partnership, according to people familiar with the matter.
    • “A deal is not guaranteed and the exact details being discussed couldn’t be learned, the people said. 
    • “Protagonist had a market value of over $4 billion as of Thursday’s close. Including a typical premium, a deal would likely value the company well above that. 
    • “”J&J is already working with Protagonist to develop an oral treatment for immune diseases including plaque psoriasis and ulcerative colitis and has the exclusive rights to commercialize the product. It already owns close to 4% of Protagonist’s shares, according to FactSet.
    • “By acquiring Protagonist, the healthcare conglomerate would also gain access to the drug rusfertide, from Protagonist and partner Takeda Pharmaceutical4502 -2.63%decrease; red down pointing triangle. Rusfertide has shown promise in late-stage testing in treating a rare blood cancer called polycythemia vera. 
    • “Both assets would complement J&J’s portfolio of immune and cancer drugs.” 
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is joining big pharma’s rush into “in vivo” cell therapies, paying $1.5 billion to acquire Orbital Therapeutics for a technology designed to rewire the immune systems of people with inflammatory conditions.
    • “The deal announced Friday gives Bristol Myers ownership of a company that’s been working on ways to genetically modify immune cells inside the body. Orbital’s lead program, OTX-201, does so by sending into cells “circular” RNA instructions training them to seek out cells with a particular protein flag. OTX-201, which is envisioned as an autoimmune disease treatment, could begin human testing next year.
    • “The acquisition expands Bristol Myers’ presence in cell therapies. The company is already one of the field’s leaders, with multiple marketed medicines for blood cancers. But, like its peers, Bristol views autoimmune disorders as a way to potentially broaden use of the complex treatments.”
  • Per MedTech Dive,
    • “Zimmer Biomet has launched two orthopedic devices with Paragon 28, the foot and ankle specialist it bought for $1.1 billion early this year. 
    • “The new products, which Zimmer reported Wednesday, add treatments for a type of shinbone break and hindfoot injuries to the company’s portfolio.
    • “Introducing the devices continues Zimmer’s efforts to maintain Paragon’s double-digit growth and expand its sports medicine, extremities and trauma (SET) business.”
  • The Employee Benefits Research Institute released its 2025 Employer Mental Health Survey.
  • Fierce Healthcare adds,
    • “Most employers offer coverage for mental health services, but where they fall short is in tracking whether those benefits are working, according to a new survey.
    • “The report, conducted by the Employee Benefit Research Institute (EBRI), found that 97% of employers offer mental health coverage and 67% offer coverage for substance abuse treatment. However, only 22% said they actively monitor whether employees are using the benefits.
    • “In addition, there is a significant opportunity for employers to do more in tracking network adequacy, the study found. Forty-seven percent of those surveyed said they receive details from vendors or collect data on provider-to-enrollee ratios, while 44% said they track employees’ distance to providers and 48% said they monitor wait times.
    • “Fewer than one-third (31%) said they collect data on out-of-network care use, which is a major barrier to behavioral health access, per the report.”
  • KFF-Peterson Health System Tracker studies “how much do people with employer plans spend out-of-pocket on cost-sharing?”
    • “By cost-sharing type, average spending on deductibles and coinsurance has increased, while copayments have remained flat relative to inflation since 2013. However, since 2021, inflation (16%) and spending on deductibles (13%) have grown at similar rates. Deductibles rose rapidly before 2019, however starting in about 2019 employers have held deductibles constant.
    • “In 2023, 66% of people with employer coverage spent at least $100 on out-of-pocket health care expenses. Among them, 39.7% spent between $100 and $999 on average, while 26% spent $1,000 or more. Over time, the share of enrollees facing over $1,000 in annual out-of-pocket costs has steadily increased.  Conversely, 18% of people with employer coverage incurred no out-of-pocket costs, and 15.4% spent less than $100 in 2023.
    • “Regarding total health spending, 56% of people with employer coverage spent $1,000 or more, including 41% who spent between $1,000 and $9,999 and 15% who spent $10,000 or more. Meanwhile, 12% of enrollees used no health care billed to their health plan in the year, which further highlights the uneven distribution of health care costs across the insured population under employer plans.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Health Economics Methods Advisory (HEMA) yesterday released its first ever Draft Report focused on the assessment of the benefits of treatment that are appropriate to consider in economic evaluation for health technology assessment (HTA) decision-making.
    • “HEMA has been convened by the leaders of three global HTA organizations to independently assess new methods and processes. The three institutions include ICER, England’s National Institute for Health and Care Excellence (NICE), and Canada’s Drug Agency (CDA-AMC).
    • “This draft report will be open for public comment until October 30, 2025, providing a unique opportunity for all stakeholders to engage in the report development process.
    • “If you are interested in submitting a public comment on the Draft Report, visit https://hemamethods.org/our-research/.”

Thursday Report — 2026 Government Contributions Announced

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • Federal News Network informs us,
    • “Federal employees and annuitants are heading for yet another year of large increases to their health insurance premiums, in both the Federal Employees Health Benefits (FEHB) program and the Postal Service Health Benefits (PSHB) program.
    • “The Office of Personnel Management announced Thursday that FEHB participants will pay an average of 12.3% more toward their insurance premiums starting in January 2026 — or in dollars, an average of $26.40 more per pay period.
    • “The upcoming 12.3% premium spike follows multiple large premium increases over the last few years for FEHB enrollees. Federal employees saw an average of a 13.5% increase for the 2025 plan year — the largest year-over-year increase in well over a decade. Feds also saw a 7.7% jump in 2024, and an 8.7% increase in 2023.
    • “The PSHB program, which is open to more than 2 million USPS employees, annuitants and family members, is also set for a large premium increase for 2026. Enrollees in PSHB will be paying 11.3% more, on average, toward their 2026 premiums. In dollars, that’s about $21.51 more per pay period.” * * *
    • “When accounting for the government’s share of FEHB costs, which is increasing by about 9.2%, premiums will rise by 10.2% overall. PSHB premiums are increasing by 9% overall, when including the government’s portion of the cost, which is going up by 8%.”
  • Per an OPM news release,
    • “Today, the Office of Personnel Management (OPM) announced the 2025 Federal Benefits Open Season will be held from November 10 through December 8, 2025, and the 2026 plans and premiums for Federal Employees Health Benefits (FEHB) Program, Postal Service Health Benefits (PSHB) Program, and Federal Employees Dental and Vision Insurance Program (FEDVIP) are now available for review
    • “This is the opportunity for eligible federal and postal employees and annuitants to enroll or make changes to their health, dental, and vision coverage for the upcoming year.
    • “During Open Season, we want to give enrollees the opportunity to review their coverage, compare coverage options, and make the choice that is right for them,” Associate Director for Healthcare and Insurance Shane Stevens said. “I strongly encourage all employees to reassess their current coverage and choose the plans that best meet their family’s needs.” * * *
    • “Read Associate Director Stevens’ blog post about this year’s Open Season here. Read how to prepare for Open Season here.”
  • Here is a link to Govexec’s article about the OPM announcement.
  • Modern Healthcare reports,
    • “Medicare Advantage insurers suffered another disappointing year under the Star Ratings quality measurement program. 
    • “The average Medicare Advantage star rating for 2026 is essentially flat at 3.66, compared with 3.65 for 2025, according to data the Centers for Medicare and Medicaid Services released Thursday.
    • “Just over four in 10 Medicare Advantage contracts — which are bundles of plans — earned at least four of five stars, the threshold to qualify for the maximum 5% bonus payment, the same as this year. Eighteen contracts, or 3.5%, won five stars, up from seven for 2025. The annual enrollment period begins next Wednesday and ends Dec. 7.”
  • The Wall Street Journal reports.
    • “Republican and Democratic senators are trading ideas on healthcare funding to forge a path out of the government shutdown, as tensions rose on Capitol Hill ahead of what is set to be a painful week for government workers and military servicemembers.
    • “Informal discussions have centered on extending enhanced Affordable Care Act subsidies temporarily, but with new guardrails meant to cut back on aid for higher-income families. One cutoff point that has been discussed among Democrats: limiting the subsidies to households at or below $200,000 of income, rather than leaving the benefit uncapped.
    • “Sen. Angus King (I., Maine), who caucuses with the Democrats, has dubbed his approach the “two and two”—a two-year extension of the subsidy capped at $200,000 of income. Sen. Mark Kelly (D., Ariz.) said that a cap would be hard to implement this year, but that discussions were occurring about reducing the subsidy for next year by limiting the benefit to people making above a certain percentage of the federal poverty line, with some members aiming for a cap at $200,000 of household income.” * * *
    • “The government shutdown started Oct. 1, and many federal workers and troops are set to miss their first full paychecks next week.”
  • and
    • “The Trump administration said it isn’t planning to impose tariffs on generic drugs from foreign countries, after months of wrangling over whether to impose levies on the vast majority of drugs that are dispensed in the U.S.
    • “The administration has been weighing duties on a range of pharmaceutical products and ingredients, using a tariff investigation under Section 232 of the Trade Expansion Act of 1962, which covers threats to national security. President Trump last month posted online that he would impose 100% tariffs on name-brand drugs on Oct. 1 but didn’t mention generics. Trump ultimately delayed imposing tariffs, as officials said they would allow for more negotiations with drug companies.
    • “The administration is not actively discussing imposing Section 232 tariffs against generic pharmaceuticals,” White House spokesman Kush Desai said in a statement. A spokesman for the Commerce Department, which is handling the tariff investigation, similarly said that the 232 investigation wouldn’t result in tariffs on generics.
    • “The move, which isn’t final and could change in the coming weeks, comes after months of debate within the administration over how to bring manufacturing of generic drugs back to the U.S. and what role tariffs should play in that effort.”
  • The Internal Revenue Service helpfully posted a revenue procedure that “sets forth inflation-adjusted items for 2026 for various Code provisions as in effect on October 9, 2025.”
  • Beckers Clinical Leadership informs us,
    • “The federal government has directed the United Network for Organ Sharing to pause some of its oversight work amid the government shutdown.
    • “As the primary contractor for the Organ Procurement and Transplantation Network, UNOS manages the nation’s donation and transplant system, facilitating matches and monitoring patient outcomes.
    • “While critical services — including operation of the organ matching system and responding to serious patient safety risks — will continue, the OPTN has been ordered to pause much of its routine oversight responsibilities. As a result, many committee meetings have been canceled, a UNOS spokesperson told Becker’s. One specific area of work being paused is the monitoring of reports for policy implementation on heart and lung transplants. 
  • MedCity News discusses the application of the White House’s artificial intelligence action plan to healthcare.
    • “Healthcare and life sciences are about to face unprecedented AI-driven regulatory changes that will reshape everything from research and development to drug approval submissions. Here are 10 steps healthcare and life sciences organizations should take to strategically prepare.”
  • Bloomberg Law relates,
    • “The US Centers for Disease Control and Prevention will reschedule a late October meeting of an influential vaccine panel that’s been weighing changes to long-standing advice around childhood shots.
    • “The Advisory Committee of Immunization Practices, or ACIP, will no longer meet on Oct. 22 and 23, according to the panel’s website. No indication was given of when a future meeting will take place or why it was moved. 
    • “A US Department of Health and Human Services spokesperson said the meeting details would be posted online once they are finalized. ACIP typically only meets three times a year, though the upcoming October meeting was set to be its fourth gathering in 2025.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “In 2022, Regeneron paid Sanofi $900 million to gain full rights to its partnered cancer drug Libtayo. Three years later, the pricey bet on the injected PD-1 inhibitor appears to be paying off.
    • “Thursday, the FDA approved Libtayo as the first immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC). The nod applies to patients who are at a high risk of recurrence after surgery and radiation.”
    • “The green light comes seven years after Libtayo became the first drug to reach the market in CSCC, as it was endorsed for patients with metastatic CSCC or those with locally advanced CSCC who are not candidates for surgery or curative radiation.”
  • Per Cardiovascular Business,
    • “San Francisco-based Bunkerhill Health has received U.S. Food and Drug Administration (FDA) clearance for its new advanced artificial intelligence (AI) algorithm designed to detect and evaluate mitral annular calcification (MAC) on routine, non-gated CT scans.
    • “According to Bunkerhill Health, the AI model—known as Bunkerhill MAC—is the first AI model cleared by the FDA to identify signs of MAC, a known cardiovascular disease risk factor. It was developed and tested using data from more than 25 academic medical centers.
    • “MAC may be missed on imaging, but it carries prognostic value for cardiovascular risk and procedural outcomes,” Alexander Sandhu, MD, MS, assistant professor in the division of cardiology at Stanford University School of Medicine, said in a statement. Stanford is one of the schools that provided data for the development of Bunkerhill MAC. “A tool that can automatically identify and quantify MAC on routine chest CT scans gives us a way to capture this information consistently and at scale, which could help guide decision-making and research across cardiology and structural heart care.”

From the public health and medical / Rx research front,

  • Politico reports,
    • “The CDC and its independent panel of vaccine advisers have quietly opened the door to wider access to Covid-19 vaccination during pregnancy, softening an earlier decision by Health Secretary Robert F. Kennedy Jr. to stop recommending that pregnant women get the shots.
    • “The CDC’s Advisory Committee on Immunization Practices voted in September to advise that adults get the Covid-19 shot through shared clinical decision-making between patients and providers. It did not specifically vote on whether the shot should be administered during pregnancy, yet the vote appears to encompass pregnant women, according to an update this month on the CDC website that reflects the new guidance.
    • “The new guidance for adults means that pharmacies can administer the vaccine to pregnant women and almost all insurers must cover the shots with no cost sharing — expanding access.”
  • Cardiovascular Business tells us,
    • “Transcatheter aortic valve replacement (TAVR) is being used to treat a rising number of patients with severe aortic stenosis. However, according to a new commentary published in the Journal of the American College of Cardiology (JACC), this trend may have gone too far.[1] The authors fear that too many low-risk patients are undergoing TAVR when they should be considered for surgical aortic valve replacement (SAVR) instead.[1] 
    • “With some U.S. states documenting that nearly 50% of patients requiring aortic valve replacement aged <65 years receive TAVR rather than guideline-directed SAVR, a significant public health concern may be looming,” wrote first author J. Hunter Mehaffey, MD, MSc, a cardiac surgeon with West Virginia University (WVU), and colleagues. “While we await long-term data from trials, there are growing questions surrounding valve durability and reintervention rates, particularly in younger and lower-risk populations. These concerns include the potential deleterious effects of accelerated structural valve deterioration, and the commensurate rise in the need for premature surgical TAVR explantation.”
    • “Mehaffey et al. emphasized that the risks associated with SAVR are typically procedural. With TAVR, however, some risks persist for up to two years after treatment. In addition, the group added, many patients who care teams treat on a daily basis were excluded from the initial studies used to track the safety and effectiveness of TAVR in low-risk patients. This creates uncertainty about whether or not a patient with a bicuspid aortic valve, for example, should be treated with TAVR over SAVR.”
  • Healthcare Dive adds,
    • “Hospitals charged Medicare more than $1.9 billion over three years for more than 200,000 unnecessary, “low-value” back surgeries for older adults, according to a new analysis of claims data from the Lown Institute.
    • “That amounts to one unnecessary back procedure every eight minutes, according to the report, which analyzed the rates of spinal fusions and vertebroplasties — or surgeries that inject medical-grade cement into broken spinal bones to relieve pain.
    • “Back surgeries have come under scrutiny due to the high risk of complications — including including infection, blood clots and strokes — which can occur in up to 18% of patients, according to the report. “Reducing unnecessary procedures, particularly invasive ones that carry grave risks, is a moral imperative,” Dr. Vikas Saini, president of Lown, said in a statement.”
  • The New York Times relates,
    • “Surgeons in China have for the first time transplanted a section of liver extracted from a genetically modified pig into a human cancer patient, they reported on Thursday.
    • “The surgeons, who described the procedure in a paper in The Journal of Hepatology, grafted the portion of pig liver onto the left lobe of a 71-year-old patient’s liver after removing the larger right lobe, where a tumor the size of a grapefruit had grown. The lobe with the porcine transplant functioned, producing bile and synthesizing blood clotting factors, the surgeons reported. The patient’s body did not reject the organ graft, which enabled the remaining left lobe of the patient’s own liver to regenerate and grow, the scientists said.
    • “The porcine liver lobe was removed 38 days after the transplant, when complications developed, the surgeons wrote in the report. The patient, who had advanced disease, died a little over five and a half months later. He would not have been eligible to receive a human donor organ in China because he had advanced cancer and hepatitis B-related cirrhosis, the authors wrote.”
  • NBC News lets us know,
    • “Just as a single night of insomnia may leave you feeling groggy and cranky, solid slumber can help you feel rested and ready to take on the day. How well you sleep over time, however, can influence deeper aspects of your health and well-being, new research shows.
    • “Five distinct sleep patterns are tied to your health, lifestyle and cognition and even how different regions of your brain connect to one another, according to a study published Tuesday in the journal PLOS Biology. 
    • “Specifically, those “sleep-biopsychosocial profiles” encompass biological, psychological and socioenvironmental factors — such as having a safe, comfortable place to sleep — that contribute to your sleep hygiene.”
  • Per Health Day,
    • “A rare but dangerous form of breast cancer is on the rise in the United States, a new report says.
    • “Lobular breast cancer rates are rising three times as fast as all other breast cancers combined, 2.8% per year versus 0.8% per year, researchers reported Oct. 7 in the journal Cancer.
    • “Although lobular breast cancer accounts for a little over 10% of all breast cancers, the sheer number of new diagnoses each year makes this disease important to understand,” said lead researcher Angela Giaquinto, an associate scientist for cancer surveillance research at the American Cancer Society (ACS).
    • “Also, survival rates beyond seven years are significantly lower for (lobular breast cancer) than the most common type of breast cancer, highlighting the pressing need for prevention and early detection strategies targeting this subtype to be brought to the forefront,” Giaquinto added in a news release.
    • “Lobular breast cancer develops in the milk-producing glands of the breast, which are called lobules, researchers said in background notes.”
  • and
    • “Concussions and traumatic brain injuries (TBI) have been considered a potential cause of ALS, also known as Lou Gehrig’s disease.
    • “But a new study argues the association might be the other way around, with concussions providing an early warning sign among folks already in the early stages of ALS (amyotrophic lateral sclerosis).
    • “The loss of muscle control that comes with early ALS might increase people’s risk for a concussion-causing fall or accident; researchers write in JAMA Network Open.
    • “If that’s so, then “TBI in some individuals perhaps (reflects) a consequence of early, subclinical ALS,” concluded the research team led by Dr. William Stewart, a neuropathologist at Queen Elizabeth University Hospital in Glasgow, U.K.”
  • The FEHBlog recalls reading that Lou Gehrig suffered a lot of concussions as a baseball player in the days before batting helmets.

From the U.S. healthcare business front,

  • Fierce Pharma relates,
    • “AstraZeneca has broken ground on a $4.5 billion manufacturing facility near Charlottesville, Virginia, confirming a report about its location six weeks ago when state lawmakers approved an economic development package for the project.
    • “The company has added an additional $500 million to its original planned investment in the site, which will manufacture active pharmaceutical ingredient (API) for the production of weight management, metabolic and cardiovascular treatments, along with drugs from AZ’s growing antibody-drug conjugate (ADC) portfolio.
    • “AZ plans to create 600 full-time roles at the site, plus an additional 3,000 jobs during construction of the facility, according to an Oct. 9 press release.  The company expects the plant to come online in the next four to five years.”
  • Bloomberg points out,
    • “UnitedHealth Group Inc. plans to acquire a 45-doctor medical practice in Massachusetts in a sign that its Optum division will keep adding doctors despite turmoil in the business.
    • “The company’s Atrius Health affiliate has agreed to buy a Boston-area primary care group called Acton Medical Associates, PC, according to a notice posted by a Massachusetts regulator.
    • “The deal shows UnitedHealth continues to expand its reach in primary care and physician groups even as that part of its business has struggled. Physician groups are part of its sprawling Optum Health business, where executives said earnings were $6.6 billion below expectations in a July call with analysts.”
  • BioPharma Dive notes,
    • “Novo Nordisk will spend billions of dollars to grow its foothold in treating a common liver condition, agreeing on Thursday to buy Akero Therapeutics for a drug that’s currently in late-stage testing. 
    • “Novo will pay $54 per share, or about $4.7 billion upfront, for California-based Akero and its lead drug, known as efruxifermin. Akero stockholders could see another $6 per share in payouts via a so-called contingent value right if efruxifermin is approved by U.S. regulators.
    • “In buying Akero, Novo is adding to a recent upswing in dealmaking involving drugs for the liver disease known as metabolic dysfunction-associated steatohepatitis, or MASH. GSK bought one prospect from privately held Boston Pharmaceuticals in May, and Roche acquired another through a deal for 89bio last month. All three deals were centered around medicines that mimic the activity of a metabolism-balancing hormone called FGF21.” 
  • Per STAT News,
    • “With a flurry of startup activity, tech to monitor the symptoms of Parkinson’s disease is gaining traction in care.
    • “On Thursday, Kneu Health, a startup spun out of Oxford University research labs, announced $5.6 million in funding for its smartphone app-based platform that measures movement, speech, and cognitive changes in people with Parkinson’s over time. In addition to working with the U.K. National Health Service, Kneu is being trialed by Cedars-Sinai, which is an investor, and Mass General Brigham. It has raised $11.2 million to date.
    • “Over the summer, San Francisco-based Rune Labs quietly raised $11 million from its existing investors with plans to add more funding. The company has raised $57 million total to support its Parkinson’s technology, which uses an Apple Watch to track symptoms and boasts a growing partnership with Kaiser Permanente. Last week, wearable device and algorithm developer Empatica announced it had acquired PKG Health, another maker of Parkinson’s tracking tech that’s been used to care for 35,000 people. Empatica’s largest business is supporting pharma companies.”
  • Per Fierce Healthcare,
    • “Similar to Medicare, commercial insurers are seeing substantially higher prices when care is delivered in a hospital outpatient department as opposed to an ambulatory surgical center, according to a multi-payer analysis published this week.
    • “However, just how much those prices increase varies substantially between individual commercial payers, suggesting there’s more room for insurers to push down spending via selective provider contracting, Brown University researchers wrote in their Health Affairs study.
    • “The researchers said their analysis is unique in focusing on site-based payment differentials across multiple payers in the commercial insurance market, which have largely been overshadowed by investigations and debate over site-neutral payment policies for Medicare.
    • “Although insurers can, and do, pursue strategies to limit payment differentials across settings, large payment differentials remain common and costly,” they wrote in the journal.”
  • and
    • “When the government entered a partial shutdown Oct. 1, hospitals across the country faced a major task: discharging, relocating or shifting care programs for the thousands of patients in hospital at home programs. 
    • “With Congress at a standoff over healthcare cuts and Affordable Care Act premium tax subsidies, the body failed to reauthorize the Centers for Medicare & Medicaid Services’ (CMS’) pandemic-era Acute Hospital Care at Home program, along with Medicare telehealth services.
    • “The CMS directed the 419 participating AHCaH hospitals to discharge or relocate Medicare hospital at home patients if Congress did not extend the waiver. Health systems received the notice about 60 days in advance of the Sept. 30 deadline, and they received periodic reminders as the shutdown drew near. 
    • “In the days before the shutdown, hospitals ramped down admissions to hospital at home programs . Since the lapse of the waiver, home hospital providers have entered a complex maze of regulations and decisions.”
  • The Wall Street Journal reports,
    • “Drug Rehabs Lure in Patients for Insurance Money—Then Leave Them on the Street.”
    • “Operators promise high-end treatment, help addicts sign up for insurance then pile on charges for little in return, say former patients and insurers.:”
  • The FEHBlog observes that’s a big bowl of wrong.

Tuesday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “The guarantee of back pay for furloughed federal employees is now in limbo, as the White House weighs a different interpretation of the 2019 law that ensures federal employees get compensated following a government shutdown.
    • “A new draft legal opinion from the Office of Management and Budget, as first reported by Axios, argues that whatever funding legislation Congress ultimately passes to end the current shutdown must explicitly include appropriations to provide back pay for furloughed federal employees. And if it’s not expressly written in the spending legislation, the OMB memo argues that furloughed workers cannot receive any retroactive compensation.
    • “A copy of the OMB document, which a senior White House official shared with Federal News Network, appears to contradict OMB’s previous interpretation of the Government Employee Fair Treatment Act, or GEFTA, which President Donald Trump signed into law in 2019 during the last government shutdown. Both OMB and the Office of Personnel Management previously affirmed that under GEFTA, excepted and furloughed employees would be given back pay as soon as possible, once any current or future shutdown ends.”
  • In the FEHBlog’s opinion, this draft OMB opinion is a lead balloon.
  • Healthcare Dive shares six takeaways from CMS Administrator Mehmet Oz’s appearance on Monday before a Washington D.C. think tank audience.
  • Modern Healthcare reports,
    • “Federal regulators say they have made inroads into speeding up the process to resolve out-of-network billing disputes. It’s not enough for frustrated providers and health insurance companies.
    • “The No Surprises Act’s Independent Dispute Resolution, or IDR, process has been a punching bag for both camps since it launched in 2022, and a backlog of cases had piled up by the beginning of this year.
    • “But the share of IDR cases unsettled after 30 business days fell from 69% in January to 34% in July, the most recent month for which data are available, according to the Health and Human Services, Labor and Treasury departments. Likewise, 96.5% of disputes submitted since 2022 are either resolved or are less than 30 business days old, the departments wrote in a notice published Sept. 19.
    • “The departments’ efforts have delivered remarkable improvements in the throughput of cases compared to prior years,” the notice says. “IDR entities are now resolving disputes faster than they are submitted.”
  • STAT News informs us,
    • “The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal.
    • “Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations.”
    • “They have to now,” said one lobbyist of their clients’ thinking, noting the “anger”with Pfizer for effectively adding to their pressure to come to an agreement with the administration.
    • “The people cautioned that negotiations remain unfinished and several variables, including the government shutdown, could delay any announcements.
    • “The growing chatter around potential announcements signals the Trump administration’s pressure campaign may be paying off. But whether the deals will actually accomplish the administration’s objective — lowering prescription drug prices — remains unknown.”
  • Fierce Healthcare points out,
    • “The current state of the Medicare Part D market is a mixed bag, with premiums declining but many payers scaling back options, according to a new analysis from KFF.
    • “The report noted that the Centers for Medicare & Medicaid Services put an emphasis on “stability” in Part D when it announced premium estimates in late September, but KFF found that the total number of stand-alone Part D plans available will decrease in 2026, marking the third straight year of shrinking plan options.
    • “Some payers are trimming down their offerings, per the report. For example, Centene is ending three drug plans offered through WellCare and Health Care Service Corporation is discontinuing one of Cigna’s three Part D plans and pulling back from certain regions.
    • “Other insurers, such as Elevance Health, are exiting the stand-alone Part D plan market entirely.
    • “For 2026, beneficiaries in each state will be able to select from between eight and 12 stand-alone Part D plans, in addition to Medicare Advantage prescription drug coverage. Across the 34 Part D plan markets, a total of 360 plans will be made available by 17 parent organizations—a decrease of 22% from 2025.”
  • “As many major insurers scale back on Medicare Advantage,” Beckers Payer Issues takes a “look at the insurers that are fully backing out.”
  • NextGov/FCW explains how OPM Director Scott Kupor plans “to attract tech talent [to federal government employment] after months of workforce cuts.”
  • Per HR Dive,
    • “The U.S. Senate confirmed Brittany Panuccio, an assistant U.S. attorney for the Justice Department in Florida, as a commissioner for the U.S. Equal Employment Opportunity Commission in a 51-47 vote Tuesday. Panuccio’s confirmation was part of an en bloc vote on several nominations.
    • “Panuccio fills the seat vacated in December by Keith Sonderling, who was named deputy labor secretary in March, and gives Republicans a majority. Her term expires July 1, 2029. 
    • “Panuccio’s confirmation restores a quorum to EEOC, which has operated with only two commissioners since January, when President Donald Trump fired Democratic commissioners Charlotte Burrows and Jocelyn Samuels before the expiration of their terms.”

From the Food and Drug Administration front,

  • Healio adds,
    • “The FDA approved Zoryve cream 0.05% for the treatment of children aged 2 to 5 years with mild to moderate atopic dermatitis, according to a press release. 
    • “Currently, there are approximately 1.8 million children aged 2 to 5 years being treated with a topical therapy for AD. Zoryve (roflumilast, Arcutis) cream 0.05% is a once-daily, next-generation phosphodiesterase-4 inhibitor that offers a nonsteroidal option for children and their caregivers.
    • “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and vice chair of the department of dermatology at University of California San Diego, said in the release. “Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reassuringly explains how to get a Covid booster vaccination under the CDC’s newly approved guidelines.
  • MedPage Today reports
    • “To prevent measles outbreaks, public health systems and clinicians should look below the 35,000-foot view of state- and county-level vaccination rates against measles, mumps, and rubella (MMR) and instead aim their focus on at-risk school districts and schools, according to a statewide analysis of Texas counties.”
  • and
    • “The pre-cooked pasta Listeria recall broadened to include pasta salads and prepared dishes at Kroger, Trader Joe’s, and more grocery stores.
    • “Some Hello Fresh meals may contain Listeria-tainted spinach, USDA’s Food Safety and Inspection Service warned.
    • “Chicken corn dog products from Foster Poultry Farms also were recalled after wood was found in the batter causing at least five injuries. (NBC News)”
  • Per Healio,
    • “Changing trajectories of heart health markers during young adulthood were associated with potentially increased risk for cardiovascular disease later in life, researchers reported.
    • “In addition, individuals who maintained higher levels of CV health through young adulthood had lower risk for incident CVD vs. those whose CV health was maintained at lower levels or declined, according to data published in JAMA Network Open.”
  • and
    • “Acupuncture needling greatly improved pain-related disability in older adults with low chronic back pain compared with usual care, a randomized controlled trial demonstrated.
    • “Acupuncture may be an effective and safe pain management tool for many older adult patients,” Lynn L. DeBar, PhD, MPH, a researcher at Kaiser Permanente Center for Health Research, told Healio. “While it is unlikely to take away all the pain, this study suggests that it can decrease pain-related disability substantively.”
  • The New York Times considers that “He was expected to get Alzheimer’s 25 years ago. Why hasn’t he? Scientists are searching for the secret in [76-year-old] Doug Whitney’s biology that has protected him from dementia, hoping it could lead to ways to treat or prevent Alzheimer’s for many other people.”
  • Per Health Day,
    • “Preschoolers who regularly overeat are likely swallowing their emotions as well, a new study says.
    • “Girls who overeat as preschoolers are more likely to develop anxiety, impulsivity and hyperactivity when they grow into teenagers, researchers reported in the journal BMC Pediatrics.
    • “The results indicate that children’s eating patterns could be early signs of mental health challenges, researchers said.
    • “Occasional overeating is normal, but if a child frequently overeats, it can be a sign of emotional struggles,” senior researcher Linda Booij, a professor of psychiatry at McGill University in Quebec, Canada, said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “A research team co-led by scientists at Institute for Bioengineering of Catalonia (IBEC) and West China Hospital Sichuan University (WCHSU), working with partners in the U.K., has developed a nanoparticle technology that studies showed can reverse Alzheimer’s disease (AD) in mice. Unlike other types of nanomedicine that rely on nanoparticles as carriers for therapeutic molecules, this approach employs nanoparticles that are bioactive in their own right, and which the team refers to as “supramolecular drugs.”
    • “Instead of targeting neurons directly, the therapy restores proper function of the blood-brain barrier (BBB), the vascular gatekeeper that regulates the brain’s environment. The BBB is a cellular and physiological barrier that separates the brain from the blood flow to protect it from external dangers such as pathogens or toxins. Through their newly reported research the investigators demonstrated that targeting a specific mechanism enables undesirable “waste proteins” produced in the brain to pass through this barrier and be eliminated in the circulation. In Alzheimer’s disease, the main waste protein is amyloid-β (Aβ), the accumulation of which impairs normal neuronal function.
    • “By repairing this critical interface, the researchers observed a significant reduction in brain amyloid-β (Aβ) levels and a reversal of Alzheimer’s pathology in the animal models, with cognitive benefits lasting up to six months following treatment.
    • “Study lead Giuseppe Battaglia, PhD, ICREA research professor at IBEC, principal investigator of the Molecular Bionics Group, and colleagues reported on their findings in Signal Transduction and Targeted Therapy, in a paper titled “Rapid amyloid-β clearance and cognitive recovery through multivalent modulation of blood–brain barrier transport,” in which they stated, “This innovative therapeutic paradigm offers a promising pathway for developing effective clinical interventions, addressing vascular contributions to AD, and ultimately enhancing patient outcomes…The therapeutic trilogy achieved—amyloid clearance, barrier restoration, and sustained cognitive recovery—establishes a blueprint for precision neurovascular medicine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “It was a repeat performance for all 10 children’s hospitals named as the nation’s best in this year’s iteration of U.S. News & World Report’s ranking.
    • “The highly watched list, now in its 19th year, reviewed outcomes, practices and surveyed opinions for 198 children’s hospitals.
    • “Of these, 86 hospitals were named in some respect, whether that be a top-10 ranking for 10 different pediatric specialties and/or as one of 50 unranked facilities named as a high performer on pediatric and adolescent behavioral health.
    • “Among these, 10 children’s hospitals were named to the list’s honor roll for scoring well across multiple specialties. That unranked collection is identical to last year’s honorees.
      • “Boston Children’s Hospital
      • “Children’s Hospital Colorado, Aurora
      • “Children’s Hospital Los Angeles
      • “Children’s Hospital of Philadelphia
      • “Children’s National Hospital, Washington, D.C.
      • “Cincinnati Children’s
      • “Nationwide Children’s Hospital, Columbus, Ohio
      • “Rady Children’s Hospital, San Diego
      • “Seattle Children’s Hospital
      • “Texas Children’s Hospital, Houston”
  • and
    • “Providers are betting on artificial intelligence to ease the pain point of prior authorization, a new survey shows.
    • “Cohere Health, which provides clinical intelligence to insurers and risk-bearing providers, polled 200 clinicians and office administrators and found that 99% of clinicians report confidence in using AI to back prior authorization. Most (96%) office administrators said the same.
    • “Two-thirds of those surveyed said a completely digital prior authorization process would significantly improve their workflows. Across the board, the respondents said the process should have real-time tracking baked into the experience, allowing them to track the status of key requests.
    • “Providers are speaking loud and clear: they want and deserve a prior authorization process that is smarter, simpler and more transparent,” said Brian Covino, M.D., chief medical officer of Cohere Health, in an announcement.”
  • Healthcare Dive relates,
    • “Saint Peter’s Healthcare System and Atlantic Health abandoned plans to merge on Monday, citing impacts of the “rapidly evolving healthcare landscape nationally.”
    • “The New Jersey-based health systems first announced plans to combine in January last year and signed a definitive agreement to merge in June 2024. 
    • “The systems shared scant details about why the deal fell apart. However, in a joint statement issued Monday both Atlantic President and CEO Saad Ehtisham and Saint Peter’s President and CEO Leslie Hirsch called the deal’s end disappointing.”
  • STAT News informs us,
    • “Just a decade ago, a doctor with multiple medical licenses was an anomaly. Sometimes physicians would apply for credentials from a few states if they lived near a border and wanted the flexibility to practice on either side, since a doctor needs to be licensed where their patient is physically located. In-demand specialists might get a few more if they wanted to see patients virtually. But in the years since Covid began driving patients online, the number of physicians seeking multi-state licensure has ballooned to support the growing field of telehealth.
    • “Within that group, a STAT analysis of physician licenses shows that a small but powerful cohort of physicians is accumulating licenses in all 50 states, plus the nation’s capital and its territories. These physicians don’t max out on licenses just to practice across state lines. Often, they own the medical groups that are affiliated with nationwide telehealth companies. A doctor’s full roster of medical licenses can be leveraged for online businesses that provide specialty care, build patient funnels for pharma companies seeking to sell drugs directly to consumers, prescribe compounded meds — or sometimes, all of the above. 
    • “In 2016, just nine physicians in the U.S. held active licenses in all 50 states, according to data from the Federation of State Medical Boards. By 2024, 172 doctors had filled out their bingo card, and another 356 doctors had acquired at least 45 licenses — significantly outpacing the profession’s overall growth.”
  • As we approach Open Season, the American Diabetes Association offers “Health Insurance Aid for Diabetes. Access to medical care is key to managing your diabetes. Get more information on resources available to people living with diabetes.”

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.”  

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Democrats made their case to President Trump for restoring billions of dollars in healthcare spending as part of any deal to avoid a government shutdown, but they said there was no breakthrough in talks, further dimming hopes of a last-minute deal.
    • “It was a frank and direct discussion” with the president and Republican leaders, “but significant and meaningful differences remain,” said House Minority Leader Hakeem Jeffries (D., N.Y.) after leaving the meeting at the White House.” * * *
    • “The open question headed into Monday’s meeting was whether Trump the dealmaker would show up, or if he was content to let Democrats go home empty-handed. Trump believes he is in a strong position and that Democrats will be blamed for shutting down the government, according to allies. A Republican close to the talks said that while Trump likes to be a dealmaker, there may not be much of a deal to be made.
    • “[Senate Minority Leader Chuck] Schumer [D., N.Y.] and Senate Majority Leader John Thune (R., S.D.) have signaled any deal would likely focus on extending health-insurance subsidies. Those enhanced Affordable Care Act tax credits, first passed in 2021 by Democrats, are set to expire at year’s end. Democrats and some Republicans want an extension, but Republicans are seeking some new income limits on who receives subsidies. They also say discussions should only take place after Congress passes the stopgap bill keeping the government funded through late November.
    • The Senate was set to vote again before the Wednesday deadline on the same GOP bill that Democrats had previously rejected. Republicans have a 53-47 majority, but they need 60 votes to pass most legislation. With the House out this week, that is currently the only option available.
  • Modern Healthcare adds,
    • “The federal government is on track to shut down at midnight EST Wednesday, when fiscal 2026 begins. President Donald Trump and the Republican-led Congress have failed to enact annual appropriations bills to finance government operations. Negotiations with Senate Democrats continued Monday.
    • “Medicare, Medicaid, the Children’s Health Insurance Program and the federal health insurance exchanges would continue operating for the immediate future, HHS announced. The first three programs are mandatory and not subject to annual appropriations and CMS would cover exchange expenses with insurance company user fees.”
  • Federal News Network reminds us,
    • “Even if an agency doesn’t pay health premiums on time to OPM, federal employees and other enrollees in the Federal Employees Health Benefits (FEHB) program, as well as participants in the Postal Service Health Benefits (PSHB) program, maintain coverage throughout the duration of a shutdown, OPM has said in shutdown guidance.
    • “Those same rules apply to coverage through the Federal Employees Dental and Vision Insurance Program (FEDVIP), the Federal Employees’ Group Life Insurance (FEGLI) program and the Federal Long Term Care Insurance Program (FLTCIP).
    • “While all FEHB and PSHB participants maintain health coverage during a shutdown, those who are excepted or furloughed are not expected to pay health premiums while a shutdown is ongoing. Enrollees, however, will have to make any payments for premiums that accumulate during a shutdown, once the shutdown ends.”
  • Govexec offers part 2 of a series of commentaries about OPM in the second Trump Administration while FedSmith reminds folks about five mistakes to avoid during the upcoming FEHB / PSHB / FedFlex Open Season.
  • Avalere Health calls attention to key health policy actions to watch for during the rest of this year.
  • Mercer Consulting informs us,
    • “The 2026 changes to the Medicare Part D drug benefit passed under the Inflation Reduction Act are generally modest compared to the significant adjustments made in 2025. However, new instructions related to determining the creditable coverage status of prescription drug coverage allow plan sponsors to utilize a revised methodology for 2026. Plan sponsors should review the new methodology as they determine the most suitable one for their particular group health plan.
    • “Prior to Oct. 15 each year, plan sponsors providing prescription drug coverage must notify Part D-eligible individuals enrolled, or seeking to enroll, in their group health plan about whether the plan’s drug coverage is creditable — generally, whether it’s expected to pay, on average, at least as much as the Part D standard prescription drug coverage. Additionally, plan sponsors are required to report the creditable coverage status of their prescription drug plans to the Centers for Medicare and Medicaid Services each year, within 60 days of the plan year’s start.
    • “The IRA significantly enhanced Medicare Part D beginning in 2025, raising concerns among some plan sponsors about whether their drug coverage would remain creditable.  Instructions provided by CMS for 2026 take into account the IRA’s enhancements and increased flexibility in how plan sponsors may determine whether their drug coverage is creditable going forward, updating their Simplified Determination Methodology for 2026. And for the first time, some Health Savings Account-qualifying High-Deductible Health Plans may be able to use the SDM to determine creditable coverage status.”
  • The American Hospital Association News tells us,
    • “The Office of Science and Technology Policy issued a request for information Sept. 26 seeking feedback on federal regulations that hinder AI development, deployment or adoption. The OSTP is requesting comments on regulations across all sectors, including health care, where the underlying assumptions, technical requirements or compliance frameworks may create unnecessary barriers to beneficial AI applications. The agency is accepting comments through www.regulations.gov until Oct. 27.”
  • and
    • “The AHA Sept. 29 sent recommendations to the Department of Health and Human Services and the Centers for Medicare & Medicaid Services to help ensure insurance plans adhere to the agencies’ health insurer pledge to reform prior authorization processes. They include monitoring plans’ progress in fully implementing existing regulations, such as the interoperability and prior authorization final rule and reforms issued in the 2024 Medicare Advantage final rule. “As a result of the enormous detrimental impact that certain prior authorization practices routinely place on patients, physicians and hospitals, the AHA has been actively pushing for reforms in this area for a long time and working with health plans to collaboratively reduce the burdens associated with these programs,” the AHA wrote.”
  • and
    • “The AHA Sept. 29 asked the Trump administration to provide exemptions for health care personnel from the proclamation issued Sept. 19 announcing changes to the H-1B visa program. The proclamation increases the fee to $100,000 for new H-1B petitions filed by employers, as well as implements other restrictions on the entry of certain nonimmigrant workers. Of nearly 400,000 H-1B petitions approved in fiscal year 2024, 16,937 of those, or 4.2% of the total filed petitions, were for medicine and health occupations, and half of those approved petitions were for physicians and surgeons.” 
  • The Labor Department’s Bureau of Labor Statistics issued its annual report
    • “Seventy-two percent of private industry workers had access to medical care plans and 45 percent of workers participated. Dental care was available to 30 percent of private industry workers in establishments with less than 100 workers, 50 percent of private industry workers in establishments with 100-499 workers, and 70 percent of private industry workers in establishments with 500 workers or more. Vision care benefits were available for 21 percent of workers in establishments with less than 100 workers, 34 percent of private industry workers in establishments with 100-499 workers, and 44 percent of private industry workers in establishments with 500 workers or more. on employee benefits in the United States.
  • Per Beckers Payer Issues,
    • “The National Committee for Quality Assurance has named Vivek Garg, MD, as its next president and CEO, effective Jan. 5.
    • “Dr. Garg succeeds NCQA founder and current president Margaret O’Kane, who will retire at the end of this year. He currently serves as chief medical officer at Humana’s CenterWell Senior Primary Care.
    • “Dr. Garg previously held leadership positions at CareMore and Aspire Health, Oscar Health and One Medical Group.”

From the Food and Drug Administration front,

  • Fierce Pharma lets us know,
    • “Kedrion Biopharma has scored an FDA approval for Qivigy for adults with primary humoral immunodeficiency (PI), a group of disorders that prevent the immune system from operating effectively. 
    • “As an intravenous immunoglobulin (IVIG) therapy, Qivigy provides patients with antibodies that are intended to help them ward off infections.
    • “Along with the approval, the Italian plasma collection specialist was quick to point out in a release that it plans to increase its investments in the United States. To support the production of Qivigy, Kedrion announced plans to invest more than $260 million in expanding its U.S. network with over 40 new plasma collection centers. 
    • “The company also said it will invest more than $60 million to expand capacity at its manufacturing facility in Melville, New York.”
  • and
    • “Johnson & Johnson’s Tremfya continues to expand its reach as now the FDA has approved the IL-23 inhibitor as a treatment for two pediatric patient populations.
    • “The agency endorsed Tremfya as a treatment for children 6 years and older who weigh at least 40 kg (88 pounds) with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
    • “In addition, children 6 and older with active psoriatic arthritis are now eligible for the drug, provided they weigh at least 40 kg, J&J said in a Sept. 29 release.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “About 58 million pounds of corn dogs and other sausage-on-a-stick products were recalled across the U.S. because pieces of wood may be embedded in the batter. (AP)
    • Meanwhile, supermarket chain Albertsons recalled several of its store-made deli products because they may contain Listeria, shortly after federal health officials warned consumers not to eat certain pasta meals sold at Walmart and Trader Joe’s over Listeria concerns. (AP)
  • and
    • “Widespread HPV vaccination slashed infection risk and delivered protection for vaccinated and unvaccinated adolescent girls and young women alike, according to a cross-sectional analysis of six regional surveillance studies.
    • “Between 2006 and 2023, the adjusted proportion of vaccinated women in the six studies who were positive for the high-risk HPV-16 and HPV-18 types covered by the first FDA-approved 2-valent HPV vaccine (2vHPV) dropped 98.4%, said Jessica Kahn, MD, MPH, of Albert Einstein College of Medicine in New York City, and colleagues.
    • “In the 17-year period, the proportion of vaccinated women who tested positive for HPV types covered by the later 4-valent vaccine (4vHPV) dropped 94.2% and fell 75.7% for types covered by the current 9-valent vaccine (9vHPV).
    • “Those declines were paired with evidence of herd protection. The proportion of unvaccinated adolescent girls and young women who were positive for at least one HPV type covered by 2vHPV dropped 71.6%. The proportion positive for at least one HPV type covered by 4vHPV fell 75.8%, they noted in JAMA Pediatrics.”
  • and
    • “In the Southern Hemisphere, the adjusted flu vaccine effectiveness rates against outpatient visits and hospitalizations were 50.4% and 49.7%.
    • “Only 21.3% of flu outpatients and 15.9% of hospitalized flu patients were vaccinated.
    • “Health authorities in the Northern Hemisphere might expect similar levels of protection against influenza, experts said.”
  • STAT News notes,
    • “Heart attacks, heart failure, and strokes don’t come out of nowhere, a new study concludes. The first time they strike, patients, clinicians, and researchers might think there were no red flags.  
    • “But a prospective cohort study reports that more than 99% of people who experienced these illnesses had at least one of four risks for cardiovascular disease. They had “suboptimal” high blood pressure, cholesterol, or blood glucose, or they were current or former smokers. More than 93% of the more than 9.3 million people in two national cohorts followed for 20 years had more than one risk factor.
    • “Among women under 60, often considered to be at lowest risk, more than 95% had at least one nonoptimal risk factor before heart failure or stroke.
    • “This almost universal prevalence of warning signs is far higher than reported in other studies, the new paper asserted.
    • “Every practicing cardiologist has seen cases in which individuals without any known risk factors sustain an MI or develop significant coronary disease,” Neha Pagidipati of the Duke Clinical Research Institute wrote in a companion editorial, referring to myocardial infarction, or heart attack. “However, the prevalence of CVD without traditional risk factors may be significantly lower than previously described.”
  • MedPage Today adds,
    • “The increase in early-onset cancers is not necessarily due to a rise in clinically meaningful cancers, researchers argued, but may be due to increased diagnostic scrutiny and overdiagnosis.
    • “Of the eight fastest-rising cancers, only two — colorectal and endometrial cancer — have shown a slight increase in early-onset mortality.
    • “For the six other cancers, stable or declining mortality rates alongside rising diagnoses suggest that greater detection (rather than more disease) may account for the trend.”
  • Per Health Day,
    • “Acute cystitis may signal the presence of urogenital cancers in middle-aged adults, according to a study published online Sept. 16 in BMJ Public Health.
    • “Filip Jansåker, M.D., Ph.D., from Lund University in Sweden, and colleagues examined the subsequent risks for urogenital cancers in men and women aged 50 years and older diagnosed with acute cystitis. The analysis included roughly 1.67 million men and 1.89 million women, including 177,736 men and 427,821 women diagnosed with acute cystitis (first event) from 1997 to 2018.” * * *
    • “It is plausible that urogenital cancer, and perhaps even precancerous changes in the urogenital organ, might increase the risk of cystitis because of compromised urinary tract and host defense,” the authors write.”
  • Genetic Engineering and Biotechnology News relates
    • “Bispecific antibodies and chimeric antigen receptor (CAR) T cells demonstrate potent cancer immunotherapy in clinical use, yet most cancers remain poorly targetable. High-affinity antibodies needed to maximize cancer killing also detect low antigen expression in normal tissue, which causes toxicity in healthy tissue. Identifying cancer-restricted cell-surface protein antigens remains an ongoing challenge. 
    • “In a new study published in Cell titled, “Safe immunosuppression-resistant pan-cancer immunotherapeutics by velcro-like density-dependent targeting of tumor-associated carbohydrate antigens,” researchers from the University of California (UC), Irvine, have reported that targeting cancer-associated glycans with binding proteins can trigger tumor cell death without toxicity to surrounding tissue. The biologically engineered immunotherapies, known as glycan-dependent T cell recruiter (GlyTR) compounds, were shown to be safe and effective in models for a spectrum of cancers, including breast, colon, lung, ovaries, pancreas and prostate. 
    • “It’s the holy grail—one treatment to kill virtually all cancers,” said Michael Demetriou, MD, PhD, a professor of neurology, microbiology and molecular genetics at the UC Irvine School of Medicine and corresponding author of the study. “GlyTR’s velcro-like sugar-binding technology addresses the two major issues limiting current cancer immunotherapies: distinguishing cancer from normal tissue and cancer’s ability to suppress the immune system.”

From the healthcare business front,

  • STAT News reports,
    • “Perimenopause is the new buzzword in the business of women’s health.
    • “The menopause market has proved so successful that companies are increasingly pushing products aimed at younger women too.”
  • Beckers Hospital Review breaks down the massive 138-hosptial Common Spirit health system’s revenue by region for the fiscal year ending June 30 in 2025 and 2024.
  • MedPage Today points out,
    • “Among more than 3 million Medicare Advantage enrollees, value-based payment models outperformed fee-for-service models for all 15 clinical quality outcomes.
    • ‘The mean score differences for blood glucose control and blood pressure control indicated “markedly better performance” with value-based payment models.
    • “Clinical quality performance consistently improved as financial arrangements moved toward 2-sided risk sharing.”
  • The Brown & Brown consulting firm discusses “Practical Approaches for Employers to Manage High-Cost Claimants in Health Plans.”
    • “Managing high-cost claimants requires a delicate balance of cost control, care quality and employee experience. Employers who invest in data-driven decision making, proactive care management and thoughtful plan design are best positioned to reduce the financial impact of high-cost claimants without sacrificing the well-being of their workforce.
    • “By taking a strategic and holistic approach, employers can turn a major cost challenge into an opportunity to enhance healthcare delivery, improve outcomes and foster a healthier, more productive employee population.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • “today that it will assess the comparative clinical effectiveness and value of Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Novavax) for the prevention of COVID-19, including both the short- and long-term effects of the infection.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in June 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The Wall Street Journal reports,
    • “Novartis NOVN said it is launching a direct-to-patient platform in the U.S. to sell a discounted version of its Cosentyx drug, the latest big pharma company to move to cut prices ahead of the Trump administration’s deadline.
    • “The Swiss pharmaceutical company said Monday that it would offer select units of Cosentyx—a drug treating immune-mediated inflammatory conditions like psoriasis and psoriatic arthritis—at a 55% discount to cash-paying patients with a prescription. The platform will come into effect on Nov. 1.
    • “Novartis’s launch of a direct-to-patient platform and the discount comes after President Trump said in a letter to pharmaceutical companies in July setting a deadline of Sept. 29 to impose cuts on drug prices.”
  • Fierce Pharma adds,
    • “As pharma companies face an imminent deadline from President Donald Trump related to his “Most Favored Nation” (MFN) drug pricing demands, the industry’s top U.S. lobbying group is touting three “major actions” by its members and calling for some policy shifts of its own.
    • “The timing of the Sept. 29 press release by the Pharmaceutical Research and Manufacturers of America (PhRMA) coincides with the deadline set by the president when he laid out the steps pharma companies “must take” to align certain U.S. prices with lower prices overseas. 
    • “But rather than directly addressing the core component of Trump’s demand, the PhRMA communication centers on its members’ infrastructure spending, patient financial assistance programs and a new website designed to compile drugmakers’ direct sales offerings.
    • “PhRMA members are planning $500 billion in U.S. investments over the next 10 years, including $100 billion in projects that haven’t been announced yet, PhRMA CEO Steve Ubl wrote in an accompanying Washington Post op-ed piece Monday.
    • “Besides the capital projects, the industry trade group also plans to launch a website compiling its members’ direct sales offerings. Over the last several months, Big Pharma players have been rolling out new direct-to-patient sales platforms that offer cash-paying patients steep discounts to list prices for certain medicines. This is one component of the president’s push to rein in U.S. prices, and pharmaceutical companies are happy to stick it to middlemen in the U.S. whenever possible.”
  • Per BioPharma Dive,
    • “Antibody drug specialist Genmab on Monday agreed to acquire Dutch biotechnology company Merus in an $8 billion deal centered around a drug that’s shown potential treating head and neck cancer.
    • “Per deal terms, Genmab will pay $97 per share in cash to acquire Merus, representing a 41% premium to the biotech’s closing price on Friday of about $68.  
    • “The deal hands Genmab a drug called petosemtamab and that’s in late-stage testing for head and neck cancer. Phase 2 data presented at the American Society of Clinical Oncology meeting in May showed that the drug helped extend survival when used alongside Merck & Co.’s immunotherapy Keytruda, a result that boosted shares and suggested it could change care for those tumors.”
  • and
    • “Emma Walmsley, the first woman to lead a big pharma company as CEO, will step down from that post Dec. 31, handing the reins of one of Britain’s premier drugmakers to commercial chief Luke Miels.
    • “In a statement Monday, GSK said Walmsley, who has been running GSK since 2017, will depart as part of a succession plan. Miels’ selection was the outcome of a “rigorous process” conducted over the last few months and that included consideration of “internal and external candidates.” He’ll start serving as GSK’s full-time CEO on Jan. 1.
    • “The CEO change ends a nine-year run for Walmsley atop GSK. During that time, Walmsley steered the big drugmaker through a turbulent period, during which it spun out its consumer health business to focus on innovative drugs while facing persistent investor pressure to boost its productivity and growth prospects.
    • “GSK also deepened its investment in oncology, expanded its HIV drug portfolio and brought to market the first vaccine for respiratory syncytial virus.
    • “Yet GSK missed an opportunity during the COVID-19 pandemic, when it decided against developing its own vaccine and partnerships with Sanofi and CureVac hit setbacks and delays.” * * *
    • ‘Miels joined GSK in 2017 after stints at AstraZeneca, Roche and Sanofi, in positions in Europe, Asia and the U.S. He will be paid a base salary of nearly 1.4 million pounds and qualify for bonuses of up to 300%, in addition to other incentives and benefits, according to GSK’s statement.
    • “Walmsley, meanwhile, will also step down from GSK’s board effective Dec. 31, but will remain with the company through Sept. 30, 2026, to support Miels “given the potential impact to GSK’s operating environment arising from geopolitics and new technologies.”