From Washington, DC,

• The Wall Street Journal reports,
  • “Nine pharmaceutical companies including Bristol-Myers Squibb, GSK and Merckagreed to lower the prices that certain federal government programs and patients pay, in a new round of industry pacts with the Trump administration.
  • “The companies said they would reduce U.S. prices on drugs to levels comparable with prices charged in other wealthy countries, which are generally much lower. In return, the companies get administration-backed reprieves from potential new U.S. tariffs for three years.
  • “President Trump announced the deals Friday at the White House, joined by top executives of the nine companies. * * *
  • Under the terms, the “most-favored nation” prices offered by companies would apply to the U.S. Medicaid program for lower-income patients, direct-to-patient services including the planned TrumpRx.gov and to newly launched drugs in the future.
  • “Merck said it would make diabetes drugs Januvia and Janumet available to eligible American patients at a cash price that is 70% off the current list price through a direct-to-patient program. 
  • “Amgen said it would sell its migraine drug Aimovig for $299 a month, nearly 60% off the list price.
  • “Some of the companies in the new round of deals also agreed to donate the main ingredients for certain medicines to a national stockpile, to be available in the event of a national emergency. 
  • “GSK is donating six-months’ supply of a respiratory inhaler, and Bristol-Myers will donate six-months’ worth of the blood thinner Eliquis.
  • “Bristol-Myers said it would provide Eliquis free to Medicaid programs.”

• The Hill adds,
  • “Medicare enrollees could save roughly half of what they usually pay for certain drugs next year, according to a study from the AARP.
  • “The study, published Thursday, found that the out-of-pocket cost of 10 drugs included in the first round of Medicare drug price negotiation will decrease substantially in five states with high enrollment in the program — California, Florida, New York, Pennsylvania and Texas — once negotiated prices go into effect on Jan. 1, 2026.” 

• Roll Call sums up Congress’s activities in the final week of this term of Congress and looks forward to January.
  • “The Senate followed the House in leaving for the Christmas break on Thursday, clearing another batch of President Donald Trump’s nominations but kicking to January the fate of the next handful of spending bills.
  • “The Senate confirmed, 53-43, an en bloc package of 97 nominations. Senators also by unanimous consent confirmed the nomination of Kevin E. Lunday to be commandant of the Coast Guard. And they reached an agreement to set up confirmation of additional Trump nominees when they return in January.” * * *
  • “[T]he aspiration of Thune and Senate Republican appropriators to get the ball rolling on a package of fiscal 2026 spending bills was not to be. The rules require unanimous consent to combine more than one regular appropriations measure into a single bill — and that agreement proved elusive despite talks that went on throughout the day Thursday.
  • “That sets the stage for January, when lawmakers will have less than a month to figure out how to fund the government and avoid another partial government shutdown. Thune said he thought another shutdown would be “toxic” for Democrats and Republicans alike.
  • “I don’t think either side wants to see that happen,” Thune said. “So I’m hoping that there will be goodwill and we’ll figure out how to fund the government.”
    
• Per a Centers for Medicare and Medicaid Service press release,
  • “The Centers for Medicare & Medicaid Services (CMS), in partnership with the Department of Labor and the Department of the Treasury (collectively, the Departments), today jointly proposed major updates to the historic health care price transparency rules established during President Trump’s first term.” * * *
  • “In line with Executive Order 14221, this proposed rule reflects the Department’s commitment to ensuring that health care pricing data is not only public but maximally impactful and actionable.
  • “Key improvements include:
    • “Requiring plans and issuers to exclude from the In-network Rate Files certain data for services providers would be unlikely to perform.
    • “Reorganizing In-network Rate Files by provider network rather than by plan, cutting redundancy, and aligning with how most hospitals report data pursuant to the Hospital Price Transparency requirements.
    • “Requiring Change-log and Utilization Files so users can easily identify what has changed from one In-network Rate File to the next and have clear information on which in-network providers are actively furnishing which items and services.
    • “Reducing reporting cadence for In-network Rate and Allowed Amount Files from monthly to quarterly, significantly reducing burden while maintaining meaningful transparency.
    • ‘Increasing the amount of out-of-network pricing information reported by reorganizing Allowed Amount files by health insurance market type, reducing the claims threshold to 11 or more claims, and increasing the reporting period from 90 days to 6 months and the lookback period of data from 180 days to 9 months. 
  • “The Departments seek feedback from stakeholders during the 60-day comment period on all elements of the proposed rule, including opportunities for further standardization and burden reduction. The deadline to submit comments is February 21, 2026.
  • “To access the proposed rule, visit: https://www.federalregister.gov/public-inspection/2025-23693/transparency-in-coverage
  • “To read the CMS fact sheet, visit: cms.gov/newsroom/fact-sheets/transparency-coverage-proposed-rule-cms-9882-p” 
    
• Beckers Payer Issues informs us,
  • “CMS has proposed two new models aimed at curbing Medicare drug spending by linking payments to international benchmarks. The proposals — GUARD for Part D drugs and GLOBE for Part B — are the latest in the CMS Innovation Center’s efforts to make prescription drugs more affordable for beneficiaries while preserving the long-term sustainability of the Medicare program.” * * *
  • “The models were published via a notice of proposed rulemaking and are now open for public comment [for sixty days] through the Federal Register.” 

• MedCity News delves into “CMS’ new ACCESS model [mentioned in yesterday’s post and], slated to begin on July 1, aims to shift traditional Medicare fee-for-service toward value-based care by tying payments to patient outcomes and encouraging tech-enabled, preventive care. Experts say it could benefit digitally mature, value-focused providers first, but its overall success will hinge on clear metrics, better data sharing and sustained participation.”

• Per a Commitee for a Responsible Budget news release,
  • “Health care spending represents about 18% of the nation’s economy and the largest area of federal spending. High and rising health care costs are driven in part by the prices for medical care, which have risen 130% since 2000, compared to 93% for overall inflation.¹ This is particularly true in commercial insurance – including large employers, the Affordable Care Act marketplaces, and public employers such as states and the federal government – where rising costs place a growing burden on workers, employers, and the federal government.² To manage costs, many employers attempt to work with insurance plans to reduce spending, but many lack the market power to command lower prices from providers, such as hospitals.³
  • “Some public employers have looked to reference pricing to address rising employee health care costs in state plans. Under a reference pricing approach, the employer sponsoring the plan establishes a maximum price for certain services. States that have launched reference pricing programs for state employees have been able to reduce costs for state budgets, as well as for enrollees.
  • “In order to reduce health care costs more broadly, policymakers could consider adopting or encouraging reference pricing for federally subsidized insurance. A possible place to start would be the Federal Employees Health Benefits (FEHB) program, which is the largest employer-sponsored commercial insurance program in the country and costs the federal government roughly $50 billion per year.⁴
  • “In this brief, we discuss an option to adopt a version of reference pricing for hospital reimbursement rates in FEHB, with the reference price based on Medicare rates. Doing so could save billions of dollars for enrollees and the federal government.”

• Tammy Flanagan, writing in Govexec, discusses “key decisions every federal employee [nearing retirement] must make. From survivor benefits and health coverage to leave payouts and TSP choices, federal employees nearing retirement face deadlines that can permanently shape their finances.”

• The New York Times lets us know that “President Trump on Thursday ordered cannabis to be downgraded to a lower category of drugs, a change that would allow for more widespread use by patients and permit cannabis producers to take advantage of standard business tax breaks.” The article explains why “moving cannabis to a category of drugs that includes some common medicines will have implications for research, businesses and patients.”

From the Food and Drug Administration front,

• Fierce Pharma reports,
  • “Seven years after the FDA’s accelerated approval of bleeding reversal agent Andexxa, which was then under the ownership of Portola Pharmaceuticals, the drug’s round trip on the U.S. market is coming to an end. 
  • “Andexxa, now under AstraZeneca’s stewardship, is slated to be pulled from the U.S. market next week, according to a Dec. 18 update from the FDA. 
  • “In the FDA communication, the agency notes that it has “received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa.” Based on the available data, the agency “considers the risks of the product to outweigh its benefits,” it said.”

• BioPharma Dive relates,
  • “The Food and Drug Administration has put a partial clinical hold on one of Merck & Co. and Daiichi Sankyo’s antibody-drug conjugates following an unexpected number of deaths in a late-stage clinical trial.
  • “Daiichi initiated a voluntary pause recruiting and enrolling the trial, called IDeate-Lung02, after “higher than anticipated incidence of grade 5 interstitial lung disease events,” a spokesperson for Merck and Daiichi said in a statement to BioPharma Dive. Following the pause, the FDA verbally placed the trial on a partial clinical hold in October. The spokesperson did not say the number of deaths recorded.
  • “During the hold, Daiichi, along with the FDA and an independent committee will review the safety data and “decide on any necessary further actions.” Trial enrollees will be able to continue treatment, but no new participants will be recruited.
  • “The experimental drug, called ifinatamab deruxtecan, or I-DXd, is one of three ADCs Merck gained the rights to through a major licensing deal with Daiichi in 2023. ADCs, which link an antibody to a toxic payload, are meant to more effectively target and destroy cancer cells while sparing the surrounding healthy tissue.”

• Per FDA news releases,
  • “The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for American patients.
  • “The products are:
    • Enlicitide decanoate — an oral PCSK9 inhibitor for lowering LDL cholesterol
    • Sacituzumab Tirumotecan — a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate
  • “High health care costs and prescription drug prices threaten to undermine all the technological advancements we see in the medical field,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re pleased to grant these vouchers to two products that may significantly contribute to our goal of improving the accessibility and affordability of healthcare in America.”
  • “With these awards,18 products have now received a voucher under the CNPV pilot program since it was established in June 2025. On December 9, the agency announced its first review decision under the program, achieving significant time savings compared to a typical review timeline.”
• and
  • “The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and America’s most innovative companies. 
  • “The FDA recognizes that many breakthrough technologies and innovative solutions relevant to its public health mission — including artificial intelligence, biotechnology, medical devices, and regulatory technology — are being developed by firms within venture capital portfolios. However, longstanding challenges, have limited engagement with innovative companies. Many existing federal contracting mechanisms favor large systems integrators and intermediaries that focus on labor-based work rather than scalable technologies. In addition, small business set-aside programs can be difficult for early-stage companies to access and have faced concerns about misuse.  
  • “We should be harnessing the incredible talent of America’s innovators, instead of relying on middlemen and D.C. insiders,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA is exploring a new approach that enables us to harness innovative capabilities and work directly with American entrepreneurs.”

• Per Cardiovascular Business,
  • “Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for its Amplatzer Piccolo Delivery System. The device was developed for clinicians to use when implanting the company’s Amplatzer Piccolo Occluder in a premature baby with a patent ductus arteriosus (PDA).
  • “PDAs are holes between two blood vessels that typically close when a baby is born. In rare instances, however, the hole stays open after birth, directing too much blood toward the lungs and impacting the neonate’s ability to breathe.
  • “The Amplatzer Piccolo Occluder first secured FDA approval and CE mark approval in 2019. It is the first transcatheter treatment to gain FDA clearance for closing a PDA in a premature infant. The device is smaller than a pea and delivered through a tiny incision in the child’s leg before it is guided to the heart using the newly cleared Amplatzer Piccolo Delivery System.
  • “We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier,” Sandra Lesenfants, senior vice president of Abbott’s structural heart business, said in a prepared statement. “With the Amplatzer Piccolo Occluder, which is the world’s smallest heart device, and now with the new delivery system to complement it, we’re continuing to advance how we meet the needs of our tiniest patients with structural heart disease.”

From the public health and medical / Rx research front,

• The Centers for Disease Control and Prevention announced today,
  • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity continues to increase across the country. COVID-19 activity is low nationally.
  • “COVID-19
    • “COVID-19 activity is low nationally.
  • “Influenza
    • “Seasonal influenza activity continues to increase across the country.
    • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
  • “RSV
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
  • “Vaccination
    • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.

• Beckers Clinical Leadership tells us,
  • “Flu hospitalization cases are evenly split between children and older adults, Northwell said, and its Cohen Children’s Medical Center in New York City is at capacity. 
  • “Flu is rising a lot faster than it did last year,” Dwayne Breining, MD, senior vice president of lab services at Northwell, said during a Dec. 18 news conference. 
  • “The other two [COVID-19 and RSV] are rising but not as fast as they did last year,” Dr. Breining said. “That’s driven by a couple of things. What’s very concerning for us is the cases of flu are rising at like 35% per week; the hospitalizations are rising at 75% per week. So we’re keeping a close eye on that trend. It could mean the flu is more severe.”
  • “Experts have said a mutated version of H3N2, “subclade K,” could be fueling the current uptick in flu activity amid earlier and more intense outbreaks abroad. The strain is a version of the influenza A virus, which is generally known to cause more severe illness, particularly in older adults and young children.
  • “At Northwell, more than one-third of flu tests for the week ending Dec. 14 were positive for influenza A’s H3 subtype. The same week period in 2024 saw a 10% flu positivity rate.”

• Per a National Institutes of Health news release from its Director Dr. Jay Bhattacharya,
  • “At the National Institutes of Health (NIH), engendering trust and confidence in the research we support is one of our top priorities. Three things guide these efforts: engaging in open, honest dialogue, acting in transparency, and delivering on our commitment to advancing science and improving health.
  • “To help guide this work, the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) recently undertook a multi-year effort to provide the NIH with a roadmap for incorporating public voices in clinical research (see NExTRAC report).  Deliberations were informed by a team of multi-disciplinary experts and community conversations across the country, specifically asked to think about strategies for incorporating public voices at every stage of the clinical research process.
  • “I am pleased to endorse these recommendations, which focus on:
    • “providing a clear vision and framework for maximally involving patients and communities in clinical research;
    • “ensuring that people and communities have meaningful input into the agenda and direction of research that is relevant and impactful for them; and
    • “increasing transparency for how research participant data are utilized in moving the scientific enterprise forward.
  • “NIH is eager to begin implementing this roadmap, starting in 2026.”

• The University of Minnesota’s CIDRAP adds,
  • Today [December 17] the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and NEJM Evidencelaunched their new Public Health Alerts initiative with reports on potential local transmission of clade 1b mpox virus (MPXV) in California and on influenza viruses circulating during the 2024-25 flu season.
  • Public Health Alerts is designed to deliver information and early warnings about emerging health threats, enabling swift, informed responses across the United States and globally.
  • “The new collaboration between NEJM Evidence and CIDRAP fills a gap in reliable data, offering expert-reviewed reports that translate frontline observations into actionable public health evidence. An NEJM Evidence editorial today explains the initiative further.
  • “Access to emerging public health data saves lives,” said infectious disease doctor Eric J. Rubin, MD, Editor-in-Chief of the New England Journal of Medicine and NEJM Group, publisher of NEJM Evidence, in a news release. “By providing this new, rigorous pathway for public health information, NEJM Group is delivering on its commitment to equip physicians with reliable information to support evidence-based care.”
  • “Rapid, credible communication has always been essential to an effective public health response,” added CIDRAP Director Michael Osterholm, PhD, MPH. “With this new collaboration, we hope to restore and strengthen that early-warning function, providing timely, evidence-based alerts that can help local and state health leaders act quickly to protect the health of people in their communities.” 

• Health Day informs us,
  • “It’s beside the point to debate whether vaping or nicotine pouches can be more healthy than smoking a cigarette, a major new report argues.
  • “Nicotine is toxic to the heart and blood vessels regardless of how it’s consumed, according to an expert consensus report published today in the European Heart Journal.
  • “Nicotine is not a harmless stimulant; it is a direct cardiovascular toxin,” said lead researcher Dr. Thomas Münzel, a senior professor of cardiology at University Medical Center at Johannes Gutenberg University in Mainz, Germany.
  • “Across cigarettes, vapes, heated tobacco and nicotine pouches, we consistently see increased blood pressure, damage to blood vessels and a higher risk of heart disease,” Münzel said in a news release. “No product that delivers nicotine is safe for the heart.”
• and
  • “Young adults are inheriting a world filled with turmoil and unrest, and this instability is leaving its mark on their mental and emotional health.
  • “A single half-hour course, however, could help them feel less anxious and depressed, by helping them increase their tolerance of uncertainty, a new study says.
  • “Young adults who took the course titled “Uncertainty-Mindset Training” continued to feel better a month after taking it, researchers reported Dec. 15 in the journal Psychological Medicine.
  • “Young people today are coming of age amid great climate, economic, social and health uncertainty,” senior researcher Susanne Schweizer, an associate professor with the University of New South Wales in Sydney, said in a news release.”

• The Washington Post points out that “feeling wonder every day improves our health and explains how to do it.

• Health Day calls attention to
  • “A new rapid test [that] could improve treatment of urinary tract infections (UTIs), by identifying the most effective antibiotic for each individual patient.
  • “The test applies different antibiotics to bacteria found in urine samples, to see which one best suppresses bacterial growth, researchers recently reported in the journal Microbiology Spectrum.
  • “This new method could cut a full day off the time between testing and prescription, researchers said, and arm a patient with the best means of clearing their infection.
  • “The sooner we know which antibiotic is effective, the more targeted our treatment can be,” senior researcher Oliver Hayden, a professor of biomedical electronics at the Technical University of Munich in Germany, said in a news release.”

• Beckers Hospital Review lets us know about GLP-1 drugs that are poised to enter the U.S. market.

• Per BioPharma Dive,
  • “An experimental anti-inflammatory drug being developed by Belgium-based Galapagos met its main goal in one Phase 2 clinical trial but missed in another, the company said Thursday.
  • “The drug, which blocks an inflammation-signaling enzyme called TYK2, helped significantly improve disease signs and symptoms in people with a muscle and skin condition called dermatomyositis. But it didn’t help people with lupus, missing statistical significance on a broad measure of clinical response.
  • “Called GLPG3667, the drug is Galapagos’ biggest remaining asset following a decision to wind down the company’s cancer cell-therapy business after an unsuccessful attempt to sell it. Galapagos may seek a partner to help further develop GLPG3667, which has some competition in the form of a Roivant medicine that could be under Food and Drug Administration review for dermatomyositis early next year.”

• Per the Genetic Engineering and Biotechnology News,
  • “As the number of antibiotic-resistant infections continues to rise, scientists are looking to bacteriophages (“phages”), viruses that infect bacteria, as an approach to tackling antibiotic resistance. A new study by researchers at the Hebrew University of Jerusalem has revealed how bacteriophages use a tiny piece of genetic material to hijack bacterial cells and make more copies of themselves.
  • “Focusing on infection of Escherichia coli by phage lambda, a bacteriophage that scientists have been studying for decades, research lead Sahar Melamed, PhD, and colleagues identified a virus-encoded small RNA molecule (sRNA) called phage replication enhancer sRNA (PreS) that acts like a hidden genetic “switch.” The team’s research indicated that this switch rewires bacterial genes to help the virus copy its DNA more efficiently and boost viral replication.
  • “The team said that understanding how phages control bacterial cells is important both for basic science and to help inform future medical applications. By uncovering how phages use tools such as PreS to take control of bacterial cells, the newly reported study provides important basic knowledge that could help scientists design new phage-based therapies targeting drug-resistant bacteria.”

From the U.S. healthcare business front,

• Kaufman Hall discusses “key health system enterprise strategy trends in 2025… and our predictions for 2026.”

• Radiology Business reports,
  • “Commercial insurer Anthem is defending a controversial new plan to penalize hospitals who use out-of-network radiologists and other physicians. 
  • “Word of the new administrative policy first surfaced in October and is slated to take effect Jan. 1 across 11 states. Anthem plans to punish hospitals by charging a 10% penalty of the allowed amount for claims that involve docs outside of its networks. 
  • Radiologists and other physicians have roundly criticized the change, labeling the policy as “deeply flawed and operationally unworkable.” The American Hospital Association also joined the chorus on Wednesday with its own sternly worded letter, calling for Anthem parent Elevance Health to rescind the policy. 
  • “However, the Indianapolis-headquartered conglomerate is standing its ground and refusing to honor such requests. Radiologists have charged that the No Surprises Act and its independent dispute resolution process already addresses concerns raised by Elevance. 
  • “We agree that the federal NSA has fulfilled its intent of protecting patients from unexpected medical bills at the point of care,” Catherine Gaffigan, MD, president of health solutions for Elevance Health, detailed in a Dec. 9 response letter to the American Medical Association and others who wrote to the company in November. “At the same time, our experience shows it has also created incentives for many care providers to remain out-of-network due to extremely high, unsustainable IDR awards—on average around nine times in-network commercial reimbursement rates—resulting from the NSA’s IDR arbitration process.” 
• Amen to that.

• Fierce Pharma relates,
  • “Pharma marketers enter 2026 asking where DTC fits in the DTP era. 
  • “That question, which few foresaw 12 months ago, reflects the fast rise of direct-to-patient (DTP) programs. In the last few months alone, Amgen, Bristol Myers Squibb, AstraZeneca, Genentech, Novartis and Boehringer Ingelheim have all launched DTP services with discounts for self-pay patients on certain popular medications, joining earlier adopters Eli Lilly, Pfizer and Novo Nordisk.
  • “The programs are changing how patients access medicines—and how patients hear about medicines could therefore evolve to reflect the emerging sales channel.” 
• and
  • “Sixteen months after luring former Roche dealmaker James Sabry, M.D., Ph.D., out of retirement and signaling a shift in its business development approach, BioMarin has announced the largest transaction in the company’s 28-year history.
  • “In a merger of rare disease specialists, BioMarin has agreed to acquire Amicus Therapeutics for $4.8 billion. The California biopharma will pay $14.50 per share, which is a 33% premium on the $10.89 Thursday closing price of the New Jersey-based biopharma and a 46% premium on its 30-day average.
  • “With the deal, BioMarin gains two rapidly growing products—Fabry disease drug Galafold and Pompe disease combination treatment Pombiliti-Opfolda. BioMarin also acquires the U.S. rights to DMX-200, a potential first-in-class small molecule in phase 3 development for the rare kidney disease focal segmental glomerulosclerosis (FSGS).”
• and
  • “Regeneron has had its hands full this year contending with regulatory setbacks, Amgen’s marketed Eylea biosimilar and Roche’s hard-charging ophthalmology rival Vabysmo. Next year, the biosimilar competition to the New York drugmaker’s blockbuster eye drug Eylea is only likely to ratchet up.
  • “Regeneron has inked another settlement related to Eylea biosimilars, this one with Alvotech and Teva, enabling the partners to launch their product “in the fourth quarter of 2026, or earlier under certain circumstances,” according to a Dec. 19 press release from Alvotech.”