From Washington, DC,

• Federal News Network reports,
  • “The Trump administration is calling on Congress to pass a four-month stopgap spending bill, in order to avoid a government shutdown, according to congressional appropriators.
  • “House Appropriations Committee Ranking Member Rosa DeLauro (D-Conn.) said in a statement Tuesday that the Trump administration is seeking a continuing resolution through Jan. 31, 2026.
  • “The administration is seeking a longer CR than some lawmakers previously considered. But the House and Senate aren’t close to getting 12 spending bills for fiscal 2026 through the normal appropriations process.”

• The American Hospital Association adds,
  • “The House Appropriations Committee Sept. 9 advanced the fiscal year 2026 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies by a 35-28 vote. The bill provides a total discretionary allocation of $108 billion for HHS, representing roughly $7 billion or 6% below the FY 2025 enacted level. Within that total, the Health Resources and Services Administration was allocated $7.4 billion, marking an $880 million decrease. The agency was provided $1.3 billion for workforce initiatives, a $37 million decrease, and $515 million for rural health, marking a $150 million increase. 
  • “Additionally, the bill maintains funding for the Hospital Preparedness Program ($65 million), Children’s Hospitals Graduate Medical Education ($395 million), National Institutes of Health ($47 billion), as well as other key initiatives within the health care workforce, behavioral health and maternal and child health programs.”  

• Roll Call informs us,
  • “Democrat James Walkinshaw won Tuesday’s special election for Virginia’s 11th District to fill the unexpired term of his former boss, the late Democratic Rep. Gerald E. Connolly.
  • “Walkinshaw, a Fairfax County supervisor, was leading Republican Stewart Whitson, an Army veteran and former FBI official, 75 percent to 25 percent, when The Associated Press called the race at 7:36 p.m. Eastern time. 
  • “Walkinshaw’s win was expected in the deep-blue Northern Virginia district, which encompasses the Washington, D.C., suburbs heavily populated by federal workers.” * * *
  • “Once Walkinshaw is sworn in, House Republicans will hold 219 seats to 213 for Democrats, with three vacancies that will be filled by upcoming special elections. 
  • “A special election in Arizona’s 7th District will take place later this month to elect a successor to the late Democratic Rep. Raúl M. Grijalva, who died in March from complications of his cancer treatment. There will also be special elections in Texas’ 18th District for the seat of the late Democratic Rep. Sylvester Turner and in Tennessee’s 7th District, where the Republican incumbent, Mark E. Green, resigned in July for a private sector job.”

• The Wall Street Journal reports,
  • “U.S. population growth will slow to a crawl over the next few decades as fertility rates decline and net immigration shrinks because of stricter enforcement, the Congressional Budget Office said Wednesday. 
  • “Deaths are now projected to exceed births in 2031. Just eight months ago, CBO had projected that threshold wouldn’t be crossed until 2033.  
  • “By 2055, the U.S. population will be about 367 million, up from 350 million today. In January, CBO had projected a 2055 population of 372 million. From 1975 through 2024, U.S. population growth averaged 0.9% annually. By the early 2050s, according to the latest projections, population growth will effectively be zero.” 

• Bloomberg Law tells us,
  • “The share of individuals in the US lacking health coverage held steady at 8%, or roughly 27 million people, in 2024, according to data the US Census Bureau released Tuesday.
  • “The data show fluctuations in the uninsured rate for different demographics, although the numbers were not considered statistically significant. Working-age Black Americans’ uninsured rate ticked up from 11.1% to 12.3%, while Hispanic Americans’ uninsured rate dipped from 23.6% to 23%. Foreign-born workers were more than twice as likely to lack health insurance as native-born workers.
  • “Coverage through public programs dropped 0.8 percentage points to 35.5%, driven by a 1.3 percentage point reduction in Medicaid enrollment. Medicaid coverage totaled 17.6% in 2024, while Medicare accounted for 19.1%.
  • “Private market coverage covered 66.1% of Americans, with 53.8% covered by their employer. Private coverage increased 0.7 percentage points, fueled by an increase in the individual market.
  • “The individual market covered 10.7% of Americans in 2024. Of that, the Affordable Care Act exchanges accounted for 4.3%.”

• Modern Healthcare reports,
  • “A little over a month before the annual enrollment period, the Centers for Medicare and Medicaid Services is urging Medicare Advantage insurers to make significant changes to how they present their offerings to beneficiaries.
  • “Perhaps most notably, CMS will incorporate provider network lists into the Medicare Plan Finder tool enrollees use to select plans, it notified insurers last month. The agency is simultaneously developing a national provider directory that will not be ready in time for the 2026 Medicare Advantage and Part D sign-up campaign, which runs Oct. 15-Dec. 7.
  • “CMS also intends to add more details about Medicare Advantage supplemental benefits and a prescription drug pricing search tool powered by artificial intelligence.”

• Per an HHS news release,
  • “The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million – the largest-ever seizure of this kind. The seizures were part of a joint federal operation in Chicago to examine incoming shipments and prevent illegal e-cigarettes from entering the country.
  • “Almost all the illegal shipments uncovered by the operation originated in China. FDA and CBP personnel determined that many of these shipments contained vague and misleading product descriptions with incorrect values, in an apparent attempt to evade duties and the review of products for import safety concerns.”

From the Food and Drug Administration front,

• Bloomberg Law reports,
  • “The FDA is planning to call on the health-care industry and consumers to provide information on the benefits of switching a prescription drug to over-the-counter, the agency’s drug chief said Tuesday.
  • “What we want people to do is focus on the benefit that we can provide to society by that switch,” George Tidmarsh, director of the Center for Drug Evaluation and Research, said at a regulatory conference held by the Consumer Healthcare Products Association.
  • “I encourage industry to really focus, in the broadest way, on the benefit of the switch,” Tidmarsh added. “Not just the specifics of that, but the impact broadly in the health-care system.” 
  • “The agency will announce the request for information in the Federal Register, the drug chief said.
  • “Switching a prescription drug to over-the-counter is a highly regulated process that widens the range of medicines available to consumers.”

• Per the AHA News,
  • “The Food and Drug Administration Sept. 10 released draft guidance on non-opioid treatments for treating chronic pain and reducing prescription opioid misuse. The guidance includes regulatory considerations regarding the categorization of multiple chronic pain conditions versus individual chronic pain indications; the design of clinical trials that ensure safety and efficacy; the evaluation of non-opioid drugs to avoid, reduce or eliminate opioid use; and the inclusion of statistical principles, patient-reported outcomes and use of expedited programs to support non-opioid drug development. The FDA is accepting comments on the guidance for 60 days following publication in the Federal Register.”

• BioPharma Dive lets us know,
  • “The Food and Drug Administration on Tuesday approved a drug-device combination for bladder cancer that its developer, Johnson & Johnson, claims represents “a new, potentially practice-changing approach.”
  • “The treatment, which J&J will sell as Inlexzo, is a medical device that releases the chemotherapy gemcitabine into the bladder. It’s approved for use in people whose disease hasn’t yet spread but doesn’t respond or stopped responding to a commonly used immunotherapy. Historically, those patients have had have their bladders surgically removed.
  • “J&J executives have predicted Inlexzo will achieve blockbuster sales, and highlighted how the company’s internal sales estimates are more than three times higher than Wall Street’s predictions. “We really think that we’ve got a winner there,” Jennifer Taubert, the head of the company’s pharmaceuticals business, said on a conference call in July.”

• Genetic Engineering and Biotechnology News adds,
  • “There are multiple different types of drugs available for the treatment of Alzheimer’s disease: cholinesterase inhibitors to treat symptoms from mild to severe, and disease-modifying immunotherapies to remove amyloid plaques and slow disease progression. In addition, vaccines that aim to clear the amyloid-beta plaques that accumulate in the brains of Alzheimer’s patients—or the neurofibrillary tangles formed by abnormal tau proteins—have been an area of active study.
  • “Now, a vaccine moves one step closer to approval. The Swedish biopharmaceutical company Alzinova recently announced that the FDA has approved the company’s Investigational New Drug (IND) application for its planned Phase II clinical study with the vaccine candidate ALZ-101 for Alzheimer’s disease. The company’s clinical development specializes in the treatment of Alzheimer’s disease, at the starting point of attacking toxic amyloid-beta oligomers.” * * *
  • “ALZ-101, a vaccine that stimulates the production of antibodies against the toxic Aβ oligomers, is Alzinova’s lead candidate. The company ran a first-in-human clinical study to evaluate the safety and immunogenicity of the oligomer-specific therapeutic vaccine ALZ-101 and released favorable data from part A of its Phase Ib clinical trial in November 2023.”

From the public health and medical/Rx research front,

• ABC News reports,
  • “The United States death rate decreased by 3.8% in 2024 as COVID fell out of the top 10 leading causes of death for the first time in four years, new provisional federal data shows.
  • “The overall rate declined from 750.5 per 100,000 people in 2023 to 722 per 100,000, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS).
  • “This marks the lowest death rate recorded since 2020, during the first full year of the COVID-19 pandemic and follows declines that began in 2022.
  • “The report also found that overall deaths fell from 3.09 million in 2023 to 3.07 million in 2024.
  • “Additionally, the report showed the three leading causes of death stayed the same from 2023 to 2024, with heart disease as the leading cause, followed by cancer and unintentional injury, respectively.
  • “‘It’s pretty noteworthy that COVID-19 fell off the top 10 and suicide, which had been had fallen off in recent years, is … ranked again,” Farida Ahmad, corresponding author of the report and health scientist at NCHS, told ABC News. “I think that’s a pretty interesting finding given where we spent the last five years.”
  • “Ahmad said fewer deaths from COVID in 2024 compared to 2023 may be a reason behind the 3.8% decline.”

• STAT News points out,
  • “Many Americans take a dark view of nicotine. The stimulant, which occurs naturally in tobacco plants, is what makes cigarettes so addictive, with smoking responsible for 490,000 American deaths each year. When people try to quit smoking, it’s often cravings for nicotine, and the surge of dopamine it releases in the brain, that foil their attempts.
  • “In this sense, nicotine is responsible for many health problems. But public health experts say that while nicotine poses risks, some nicotine products are safer than cigarettes — and they worry popular misconceptions about the chemical’s effect on the body are doing more harm than good. 
  • “A majority of people in the U.S. wrongly believe that nicotine is the substance in cigarettes that causes cancer. In fact, “the harm from smoking comes from the burning of the ingredients in a cigarette, not from the nicotine itself,” said Jamie Hartmann-Boyce, a health policy researcher at the University of Massachusetts Amherst. More than 70 carcinogens have been identified in the cigarette smoke produced by the combustion of tobacco, which can damage people’s DNA and lay the groundwork for cancer.
  • “For many years, cigarettes were the main way that most Americans consumed nicotine. That meant it wasn’t a big problem from a public health perspective if people conflated the dangers of smoking with the dangers of that particular chemical, so long as that helped deter them from lighting up.
  • “Now, thanks to the more recent introductions of smoke-free options like e-cigarettes and nicotine pouches, “we are in a totally different landscape when it comes to commercial nicotine products,” Hartmann-Boyce said.”

• The University of Minnesota’s CIDRAP notes,
  • “One more measles case has been reported in Wisconsin’s Oconto County measles outbreak. The new case raises the state’s total to 25. All 25 cases have been in unvaccinated individuals, and 2 people have required hospitalization.  
  • “The Centers for Disease Control and Prevention (CDC) has posted its weekly measles update, and 23 more cases have been recorded since last week, raising the national total to 1,454. There are two more outbreaks, raising the total number of outbreaks to 37. Eighty-six percent of cases reported this year are linked to outbreaks.”
• and
  • “A new survey of more than 21,000 US adults shows that those who reported food insecurity had a 73% higher chance of reporting post–COVID-19 condition, or long COVID. 
  • “The study was published yesterday in JAMA Network Open and adds to a growing body of literature that links food insecurity with delayed or forgone medical care, worsened mental health, and racial disparities during the COVID-19 pandemic, the authors said. This is the first known study to link food insecurity to long COVID.”

• Per MedPage Today,
  • “The American Academy of Family Physicians (AAFP) split with federal health officials and recommended that all U.S. adults get an updated COVID-19 vaccine for the upcoming respiratory virus season.
  • “In particular, people 65 years or older, those at increased risk for severe outcomes, and anyone who has never received a COVID-19 shot before should be prioritized for vaccination, AAFP said.
  • “The move follows recent recommendations from the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG), which broke with federal COVID-19 vaccine guidance for children and pregnant women.”
  • “History shows us that vaccines have eradicated diseases that were disabling and deadly in the past, and we can keep it that way, if we continue to vaccinate,” Margot Savoy, MD, the AAFP’s chief medical officer, said in a statement. “AAFP’s recommendations are closely aligned with other medical societies to ensure continuity for both patients and physicians.”
  • :Like the recent AAP guidance, AAFP says that all children ages 6 to 23 months should be vaccinated against COVID-19. For children and teens ages 2 to 18 years, clinicians should use a risk-based, single-dose approach, according to the new recommendations. The AAFP said it supports immunization access for any family wanting COVID-19 vaccination.
  • The AAFP also recommends that women who are pregnant at any stage or lactating should get a COVID-19 shot, in line with ACOG’s recent recommendations.

• The Washington Post reports,
  • Persistent sleeplessness may be far worse than a passing annoyance — gradually unraveling memory and mental sharpness, according to new research.
  • A study published Wednesday in Neurology, the journal of the American Academy of Neurology, identifies a troubling link: Older people who have chronic insomnia appear more likely to experience accelerated aging of the brain. These changes are revealed in both cognitive tests and imaging scans showing the altered structure of the brain.
  • The research involved 2,750 cognitively healthy adults with an average age of 70. The participants, who were tracked on average for 5.6 years, underwent annual testing of executive functioning, visual-spatial reasoning and other dimensions of cognition.

• Per Beckers Hospital Review,
  • “A study found that GLP-1 drugs are associated with a lower risk of fractures, including hip and osteoporotic fractures. 
  • “The research, led by scientists from China and published in Acta Diabetologica, analyzed more than 490,000 adverse event reports from the FDA’s Adverse Event Reporting System between 2004 and 2022. Of the reports, 99,000 involved GLP-1 receptor agonists. 
  • “The study found that compared to other diabetes medications, GLP-1 receptor agonists had the lowest reporting odds ratio of any fracture-related adverse events, at 0.44. 
  • “The trend surfaced across fracture types, including osteoporotic and hip fractures. Among individual GLP-1 receptor agonist drugs, albiglutide showed the most pronounced reduction in fracture risk, researchers said.”

From the U.S. healthcare business front,

• The Wall Street Journal reports,
  • “U.S. businesses are facing the biggest health-insurance cost increases in at least 15 years, after already-steep boosts in recent years that have pushed the annual expense for family coverage high enough to equal the price of a small car.
  • “Costs for employer coverage are expected to surge about 9.5% in 2026, according to an estimate from Aon, while an employer survey by WTW suggested 9.2%. Both benefits-consulting firms’ projections, which were provided exclusively to The Wall Street Journal, would represent the fastest rate of increase since at least 2011, when the price tags for employer coverage were far lower than the recent average of roughly $25,500 for a family plan.
  • “Other employer surveys conducted this year have generated similar findings—sharp hikes in health-coverage spending for next year, on top of two years of significant increases.”

• Modern Healthcare reports,
  • “Kaiser Permanente and Renown Health signed an agreement to form a joint venture to operate a health plan and ambulatory care services in Nevada. 
  • “As part of the deal, Kaiser would acquire a majority stake in Renown’s insurance arm, Hometown Health, which has more than 73,000 members. Kaiser plans to start offering health plan coverage in northern Nevada as Kaiser Permanente Nevada with an open enrollment period late next year, according to a Wednesday news release.
  • “Kaiser Permanente Nevada would also open ambulatory sites with Renown in the Reno, Nevada, area. 
  • “The deal is expected to close in early 2026, pending regulatory approval.
  • “If approved, the joint venture would mark Oakland, California-based Kaiser’s expansion into Nevada. Kaiser already has more than 12.6 million health plan members in eight states and Washington, D.C.”
• and
  • “Dr. Craig Albanese, CEO of Duke University Health System, will step down from his role to become president of integrated care and coverage for Kaiser Permanente effective Sept. 29.”
    
• STAT News tells us,
  • Lilly “has signed a collaboration agreement with Remedium Bio to develop gene therapies for obesity and type 2 diabetes, Remedium said yesterday.
  • “This is part of a movement by pharma companies to develop longer-lasting treatments for obesity, which they argue will be more attractive to patients than the current therapies that are injected once a week. Novo Nordisk, along with Wave Life Sciences and Arrowhead Pharmaceuticals, have been studying the potential of using RNA-interference to treat obesity.
  • “However, it’s not yet clear how feasible it would be to create a long-lasting treatment for obesity, much less one that is a one-time therapy. Some experts also fear an over-medicalized approach to addressing the issue of high obesity rates. (We wrote about all that in an earlier story here.)

• Per MedTech Dive,
  • “Boston Scientific has agreed to buy Elutia’s two bioenvelope products for $88 million, the companies said Tuesday.
  • “The agreement will give Boston Scientific control of Elupro and Cangaroo, devices designed to promote wound healing to prevent complications after pacemaker or defibrillator implantation. 
  • “Elupro and Cangaroo compete with Medtronic’s TYRX. BTIG analysts said in a note to investors that they believe “the Elupro bioenvelope may offer clinical and handling advantages over TYRX.”

• Per Fierce Healthcare,
  • “Oracle Health is using its data and technology muscle to move out ahead in the healthcare AI arms race.
  • “Electronic health record companies are moving quickly to integrate AI tools into their platforms as advances with agentic AI open up new opportunities to tackle clinical workflows along with revenue cycle, patient communications and even clinical trial recruitment.
  • “Oracle, which owns EHR company Cerner (now Oracle Health), touted its latest AI capabilities for providers and AI-powered EHR features Thursday morning during its Health and Life Sciences Summit in Orlando, Florida.
  • “The data and technology company is putting more focus on its AI, data and cloud capabilities as rival Epic is also ramping up its AI tech within its EHR while also extending its reach to payers, life sciences and medical device companies.”

• Radiology Business adds,
  • “Experts are pushing for new generalist radiology artificial intelligence models that move beyond single tasks and consolidate image interpretation assistance into one total package. 
  • “Scientists made their case in an editorial published Tuesday by Radiology, noting that narrow AI solutions suffer from financial limitations such as unsustainable price scaling and market fragmentation. Generalist AI could address these and other clinical and operational challenges, producing comprehensive reports that reduce radiologist effort and “unlock new value propositions.” 
  • “Recent advancements such as foundational models—trained on diverse datasets and adaptable to a wide range of downstream tasks with minimal training—pave the way for this method.”