From Washington, DC,

• Per a Senate news release,
  • “U.S. Senators Mike Crapo (R-Idaho), chair of the Senate Finance Committee, and Bill Cassidy, M.D. (R-Louisiana), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, unveiled the Health Care Freedom for Patients Act, historic Republican legislation to lower health care costs and give money directly to families to control their own care. This bill is an alternative to Democrats’ temporary COVID bonuses, which send billions of tax dollars to giant insurance companies without lowering insurance premiums.
  • “Giving billions of taxpayer dollars to insurers is not working to reduce health insurance premiums for patients,” said Senator Crapo. “We need to give Americans more control over their own health care decisions. This bill builds on the work we did in the Working Families Tax Cuts Act and will help Americans manage the rising cost of health care without driving costs even higher.”
  • “Instead of 100 percent of this money going to insurance companies, let’s give it to patients. By giving them an account that they control, we give them the power. We make health care affordable again,” said Dr. Cassidy.
  • “This legislation:
    • “Sends money to patients, not giant insurance companies;
      • “Americans on affordable bronze and catastrophic plans would access these dollars in a Health Savings Account (HSA).
      • “These funds cannot be used for abortion or dangerous gender transitions.
    • “Lowers insurance premiums by funding cost-sharing reduction (CSR) payments;
    • “Empowers Americans to choose the insurance plan that fits their needs by increasing access to low-cost catastrophic plans;
    • “Prevents illegal immigrants from accessing Medicaid by requiring states to verify citizenship and immigration status before coverage; and
    • “Stops taxpayer dollars from funding gender transition services under Medicaid and excludes them as an essential health benefit for plans sold on the Obamacare exchanges.” * * *
    • Click here for a one-pager.
    • Click here for bill text.

• MedPage Today reports,
  • “Members of the Medicare Payment Advisory Commission (MedPAC) generally responded favorably Thursday to a draft recommendation to increase reimbursement in 2027 for physicians who treat Medicare patients — with one exception.
  • “The MedPAC chairman’s draft recommendation was to “increase payment rates for physician and other health professional services by 0.5 percentage points more than current law.” However, commission member Brian Miller, MD, MPH, of Johns Hopkins University in Baltimore, pointed out that last year, “[MedPAC’s recommended] physician fee schedule update … was a net update of 3%.”

• Govexec tells us,
  • “The Trump administration laid out its plans to “end weaponized government” in its new management agenda released Monday. 
  • “The latest President’s Management Agenda includes goals to eliminate “woke” programs, downsize the government workforce and real estate portfolio, implement workforce reforms and modernize government technology, as well as targets to “annihilate government censorship of speech” and centralize government contracting.
  • “The agenda reflects much of the Trump administration’s longstanding priority to drastically reshape the government, an objective the White House focused on immediately after the inauguration through its Department of Government Efficiency.”

From the Food and Drug Administration front,

• Per an FDA news release,
  • “The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  [The manufacturer is Gamida Cell Ltd.]
  • “This approval is revolutionary in the therapeutic landscape and fundamentally changes how we approach treatment for SAA, where earlier treatment has potential to alter one’s life course,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “Severe aplastic anemia is a rare blood disorder that can be fatal, and the FDA remains committed to expanding treatment options for patients with this disease.”  

• CNN adds,
  • “Medical technology company MED-EL announced Thursday [December 4] that the US Food and Drug Administration has approved expanding the use of its Synchrony cochlear implants to children as young as 7 months who have bilateral profound sensorineural hearing loss. The implants were previously indicated for 9 months and older.”

From the judicial front,

• The Wall Street Journal reports,
  • “The Supreme Court seemed poised Monday to expand the president’s power to fire the heads of many regulatory agencies, even as one pivotal justice expressed a desire to insulate the Federal Reserve from political pressure.
  • “During 2½ hours of oral arguments, the justices probed the limits of President Trump’s assertion of virtually unfettered authority to remove agency leaders, despite federal laws that protect them from being fired over policy disagreements.
  • “Justice Brett Kavanaugh pointedly asked Solicitor General D. John Sauer about concerns from economists that a broad victory for Trump in the case would jeopardize the independence of the Fed’s board of governors.
  • “I share those concerns,” said Kavanaugh, a Trump appointee.
  • “Still, Kavanaugh and the other five conservative justices were, as expected, mostly receptive to the administration’s argument that the president is entitled to more control over dozens of regulatory bodies in the executive branch, such as the Federal Trade Commission and the National Labor Relations Board.”

From the public health and medical / Rx research front,

• The Wall Street Journal reports,
  • “Brayan Garcia was driving along a highway in his red Toyota Corolla when he slammed into the back of a Ram pickup truck that was stopping at an intersection in West Texas.
  • “Garcia, 22, died at the scene of the early morning crash. His Corolla sustained heavy damage, its hood ripped off entirely. Debris was scattered across several lanes. But despite hitting the truck directly, the Corolla’s air bags never went off.
  • “Toyota had recalled Garcia’s car in 2020 over a dangerous defect that could stop its air bags from deploying. But Garcia’s vehicle hadn’t gotten the fix, like millions of others currently on the road. 
  • “From 2015 to 2024, about 12 million vehicles were recalled for safety defects that could result in air bags not deploying. These recalls—37 in total—included models made by General Motors and Ford as well as luxury brands such as Mercedes-Benz and Audi. 
  • “About 2.6 million, or around 22%, of affected vehicles remain unfixed, according to an analysis of the latest National Highway Traffic Safety Administration data by The Wall Street Journal.
  • “The Journal found 12 people, including Garcia, who died after crashes in Toyotas and other vehicles where the air bag was under recall, hadn’t been repaired and didn’t deploy. 
  • “The NHTSA data reveal a broader problem: Roughly one in three cars recalled for all reasons goes unfixed. The rate is roughly the same even for serious flaws such as failing brakes, engine fires or the air bag defects reviewed by the Journal.”

• The New York Times relates,
  • “The statistics are incontrovertible: Since 1992, the diagnoses of eight cancers has doubled in the United States in patients under age 50, including cancers in the thyroid, anus, kidney, small intestine, colorectum, endometrium and pancreas, as well as the blood cancer myeloma. Other types, including breast cancer, also are on the rise.
  • “The magnitude and speed at which early onset cancer incidence has increased is unlike most cancer trends ever observed (the possible exception being cigarette smoking and lung cancer),” the American Association for Cancer Research said in its announcement of a special conference being held this week that will explore the rise in cancers among younger people.
  • “The sharp uptick has been agonizing for these younger patients and many of their doctors.
  • ‘The patients wonder: Why did I develop cancer? And how will my life be transformed by potentially excruciating treatments?
  • “Their doctors share these questions, and some have additional concerns: What if these cancers had never been detected? Are doctors offering treatments to younger patients with early-stage diseases that may do as much harm as good?”

• The Washington Post tells us,
  • “Children who returned to in-person schooling during the coronavirus pandemic saw improvements in their mental health, according to a new study that found school reopenings were associated with significant declines in diagnoses of anxiety, depression and other conditions.
  • “The findings, the study authors say, underscore that the social structure and support schools provide protected children’s mental well-being during the pandemic.
  • “Researchers from the Harvard T.H. Chan School of Public Health and Elevance Health, which is a private health insurer in California, analyzed medical claims for more than 185,000 California children ages 5 to 18 between March 2020 to June 2021. Before schools reopened about 5,200 children had a mental health diagnosis and that numbers rose to 6,500 over the course of the pandemic.
  • “But the researchers said after schools reopened, trends in mental health diagnoses, medications and spending dropped relative to trends in schools that stayed closed.”
    
• Health Day informs us,
  • “The U.S. stillbirth rate dropped slightly last year, offering some hope after several years of uncertainty, according to new data from the U.S. Centers for Disease Control and Prevention (CDC).
  • “The report, released Dec. 3, found a 2% decline in stillbirths in 2024. Even with that improvement, nearly 20,000 pregnancies ended in fetal death. That’s equal to about 5.4 stillbirths for every 1,000 pregnancies lasting 20 weeks or longer.
  • “This is the lowest national rate seen in decades, although the CDC said that it does not necessarily break previous records.”

• The American Medical Association lets us know “What doctors wish patients knew about strep throat.
  • “What is causing that sore throat? It could be strep, and it needs to be treated the right way. Two Ochsner Health physicians share more about strep throat.”

• Per Healio,
  • “In an analysis adjusted for tobacco cigarette use, the likelihood for asthma and COPD significantly rose with daily cannabis inhalation over a 30-day period, according to results published in Journal of General Internal Medicine.
  • “I hope these results give clinicians more confidence in stating that there are serious concerns about negative health impacts of inhaling cannabis on the lungs,” Alison S. Rustagi, MD, PhD, adjunct assistant professor at University of California, San Francisco, told Healio.
  • “We don’t have enough information now to say there’s a causal link, but we also have reason to think that there may be harm to the lungs from cannabis,” she continued. “This is important for patients to know as they make health decisions.”

• From the American Society of Hematology conference, now underway in Orlando, Florida,
  • Per BioPharma Dive,
    • “An experimental drug from Terns Pharmaceuticals is showing it may emerge as a threat to multiple established medicines for a slow-growing blood malignancy known as chronic myeloid leukemia. 
    • “According to results presented at the American Society of Hematology meeting on Monday, Terns’ drug, codenamed TERN-701, helped a majority of study participants with CML who had received previous treatments significantly reduce the number of diseased white blood cells in their bloodstream. The findings suggest the drug, a type of targeted, oral treatment, may eventually be competitive with widely used medicines like Novartis’ Scemblix, which is expected to generate more than $4 billion in peak yearly sales.”
  •  and
    • Eli Lilly was the last company to bring to market a so-called BTK inhibitor for leukemia and lymphoma. But study results revealed Sunday show Lilly’s medicine may be more effective — and potentially safer — than the oldest drug in its class. 
    • The data come from a study testing Lilly’s Jaypirca directly against AbbVie and Johnson & Johnson’s Imbruvica. Early results presented at the American Society of Hematology meeting suggest Jaypirca helped induce responses in more people with chronic lymphocytic leukemia or small lymphocytic lymphoma than Imbruvica. More definitive measures of impact — such as effects on disease progression and survival — are pointing in Jaypirca’s favor as well, though additional follow-up testing is needed to confirm those benefits.
    • “The results could be crucial in helping Lilly boost sales of Jaypirca as Imbruvica, which was launched in 2013 and has since been a regular blockbuster, approaches the end of its patent life.”
  • Per STAT News,
    • “With so-called menin inhibitors now approved for patients with certain types of advanced acute myeloid leukemia, research efforts are shifting to find uses for the genetically targeted drugs in newly diagnosed patients.
    • “Kura Oncology presented preliminary results today from a study that combines Komzifti, its menin-blocker, with two standard AML treatments. In an analysis that encompassed 40 patients with newly diagnosed, menin-susceptible AML, the triplet regimen showed a complete remission rate of 86% with a manageable safety profile.
    • “Syndax Pharma reported results from its own menin-inhibitor combination study in newly diagnosed AML patients on Saturday at the ASH meeting.”

• Per Fierce Pharma,
  • “UCB plans to file for regulatory approval of Fintepla to treat a third epileptic condition “as soon as possible,” the company said, as it reported results of a phase 3 trial in patients with the ultra-rare cyclin-dependent kinase-like-5 (CDKL5) deficiency disorder.
  • “The study of 87 patients aged 1 to 35 with CDKL5 achieved its primary endpoint, as Fintepla demonstrated a statistically significant reduction in seizures compared with placebo. The trial also achieved two of its three secondary objectives, the Brussels-based company said at the American Epilepsy Society (AES) conference in Atlanta.
  • “Fintepla was first approved in 2020 to treat seizures associated with Dravet syndrome (DS), a rare, severe form of epilepsy that affects roughly 20,000 in the U.S. Two years later, Fintepla gained expansion into a larger epilepsy indication, Lennox-Gastaut syndrome (LGS), which affects approximately 48,000 in the U.S. In both indications, the cherry-flavored oral solution is cleared for patients age 2 and older.”

• Per a National Institutes of Health news release,
  • “A study funded in part by the National Institutes of Health (NIH) has revealed important insights into the genetics of deposits in the eye, known as reticular pseudodrusen (RPD), that are linked to greater risk of vision loss among people with age-related macular degeneration (AMD). The study underscores that AMD is not one disease and highlights the need for novel treatment approaches.
  • “This study could help explain why drugs that target just the complement pathway have shown a minimal effect in slowing geographic atrophy,” said Anand Swaroop, Ph.D., chief of the Neurobiology Neurodegeneration and Repair Laboratory at NIH’s National Eye Institute (NEI) and a coauthor of the study report. “It’s clear that AMD involves multiple pathways that differentially synergize to generate distinct phenotypes.”

• Per the Genetic Engineering and Biotechnology News,
  • “Terray Therapeutics has achieved its first discovery milestone in the company’s multi-target collaboration with Bristol Myers Squibb (BMS). Under the terms of the agreement, which began in 2023, Terray will discover and develop small molecule compounds against a set of targets nominated by BMS. BMS will subsequently assume responsibility for development and commercialization. 
  • “While therapeutic details of the milestone have not been disclosed, Terray describes the target as “novel and difficult to drug,” and representative of the company’s Experimentation Meets Machine Intelligence (EMMI) platform.”  

• Beckers Hospital Review calls attention to “23 recent drug shortages and discontinuations, according to the FDA’s drug supply databases.”

From the U.S. healthcare business and artificial intelligence front.

• Modern Healthcare unveiled its 2025 list of the top 100 most influential people in healthcare. Here are the top five:
  • 1. Sam Altman, co-founder and CEO, OpenAI
  • 2. Greg Adams, Chair and CEO, Kaiser Permanente
  • 3. Judy Faulkner, founder and CEO, EPIC Systems
  • 4. Stephen Hemsley, Chair and CEO, UnitedHealth Group
  • 5. Eugene Woods, CEO, Advocate Health

• STAT News reports,
  • “Health insurance companies have lamented fast-rising medical expenses for more than two years. This year is no different as Americans continue to get more carethan insurers expected. 
  • “One of the main culprits of that higher spending: prescription drugs, and GLP-1s in particular.
  • “Some insurers spent more on drugs in the first nine months of this year than they did in all of 2024, financial documents analyzed by STAT show. For many, drug expenses are up more than 20% in 2025. The proliferation of GLP-1s — the injectable drug blockbusters that lead to substantial weight loss — has played a leading role and has led insurers and employers to consider whether they should stop covering them completely.” * * *
  • “Cynthia Cox, a vice president at health policy and research organization KFF who has studied health care spending across all types of health insurance markets, said GLP-1s are pressuring pretty much every insurer. “It’s not all GLP-1s, but I think a lot of the growth is,” she said.” 
    
• The Wall Street Journal adds,
  • “Drugmakers are moving to sell their medicines directly to patients, abandoning the middlemen they have long relied on.
  • “The shift is a huge departure from how pharmaceutical companies including Eli Lilly, Novo Nordisk and Pfizer have sold drugs for decades and threatens the multibillion-dollar business of firms that have traditionally filled prescriptions. 
  • “It is saving some patients hundreds of dollars off the cost of prescriptions because companies have been lowering the prices for drugs sold directly. 
  • ‘Meantime, drugmakers who have been rolling out the services in recent months see a big opportunity to boost sales, though they risk losing revenue if they don’t offset lower prices by selling to more patients. 
  • “For the first time, pharma is actually looking end-to-end at the full patient journey,” said Pratap Khedkar, chief executive of pharmaceutical consulting firm ZS. “That is a very different mindset than has been the case for the last 50 years.”  

• Brown & Brown has made available the 2026 edition of its Employer Health and Benefits Strategy Survey.

• Fierce Healthcare tells us how “CommonSpirit Health is working to accelerate its recently launched turnaround plan.”

• Cardiovascular Business points out,
  • “Edwards Lifesciences held its annual investor conference, predicting considerable sales growth in 2026 and highlighting the company’s continued momentum in the area of structural heart disease. Transcatheter aortic valve replacement (TAVR) and transcatheter tricuspid valve replacement (TTVR) are two areas expected to experience significant growth in the year ahead. 
  • “For 2026, Edwards Lifesciences is currently projecting overall sales growth of 8% to 10%  in addition to an adjusted earnings per share of $2.80 to $2.95. TAVR sales are expected to play a major role thanks to the continued success of its Sapien 3 platform and the planned JenaValve acquisition first announced in July 2024. In fact, the company projects TAVR sales to hit anywhere between $4.6 billion and $4.9 billion in 2026, good for a growth rate of 6% to 8%, respectively. Edwards Lifesciences also pointed to progress in the use of TAVR for patients with aortic regurgitation as a crucial step forward for patient care. 
  • “In addition, transcatheter tricuspid and mitral valve technologies are expected to hit sales of $740 million to $780 million, up 35% to 45% compared to 2025. On the tricuspid side of things, the company’s Evoque device for TTVR represents a particularly important piece of the puzzle, with two-year data on the valve expected by the second quarter of 2026.”

• Beckers Payer Issues informs us,
  • “Elevance Health has rolled out its virtual assistant to 22 million commercial members, with a Medicare expansion planned for 2026.
  • “The tool, accessible through the Sydney Health app and affiliated plan websites, allows members to ask plain-language questions about coverage, costs, and providers. For example, members can inquire whether a surgery is covered and receive personalized cost estimates, a coverage breakdown, and a list of in-network providers, according to a Dec. 5 news release.
  • “The rollout is part of Elevance’s broader AI push across its operations. The company has deployed AI tools for internal workflows, call center automation, and clinical decision-making. The company has said it plans to invest several hundred million dollars in AI and digital initiatives.”