From Washington, DC

• The Wall Street Journal reports,
  • “Mehmet Oz arrived on Capitol Hill last week to pitch Republicans on an idea to codify into law President Trump’s drug-pricing model, which ties U.S. pharmaceutical costs to lower prices typically paid abroad.
  • “Oz, the Centers for Medicare and Medicaid Services administrator, could sense the skepticism from GOP senators—members of the Finance Committee—as they raised concerns about industry backlash and a potential chilling effect on innovation.
  • “You read the room,” Oz said in an interview. “When’s the right time to tell them they need to do something different?”
  • “The move marked the opening effort of the administration’s push to advance the president’s planahead of the midterm elections, as healthcare costs have become a top voter concern. While Trump has proposed sending money directly to Americans through Health Savings Accounts to ease those costs, that discussion was absent from Oz’s talks with Republicans, he said.
  • “That’s not the most important issue for us,” said Oz, the former television host and celebrity surgeon widely known as Dr. Oz. He emphasized making sure that pricing deals reached under Trump with more than a dozen pharmaceutical companies endure beyond his time in office.”
• and
  • “The White House on Thursday launched its drug-pricing website, dubbed TrumpRx, the culmination of efforts by the administration to bring down pharmaceutical costs for some consumers.
  • “When it launched, it had roughly 40 drugs available, including obesity treatments Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound and infertility treatments such as Gonal-F from EMD Serono. The prices for the drugs on TrumpRx were generally much lower than their sticker price, with President Trump touting some discounts of hundreds of dollars a month. The website, TrumpRx.gov, allows customers to search for specific medicines and purchase them through a manufacturer’s direct-to-consumer site, or in some cases gives users coupons that they can present at certain pharmacies.” * * *
  • “The website likely won’t have a substantial impact on the amount most Americans pay for their prescriptions, as most of Americans are insured—either through private or government plans—and are likely to get a better deal on the drugs via their coverage. The roughly 27 million Americans who are uninsured are those most likely to benefit from the direct-to-consumer offerings.” 
    
• Here is a link to the White House’s fact sheet on TrumpRx.

• Govexec tells us,
  • “The U.S. Postal Service on Thursday reported that it experienced a net loss of nearly $1.3 billion in the first quarter of fiscal 2026, as there continues to be a lack of consensus among postal leaders, stakeholders and lawmakers about how to fix the agency’s longstanding financial challenges. 
  • “Officials attributed the loss to a $634 million increase to workers’ compensation, among other spending hikes, paired with a $264 million reduction in operating revenue. In comparison, USPS saw a net income of $144 million during the first quarter of fiscal 2025. 
  • “USPS, however, experienced a net loss of $9 billion in fiscal 2025, and officials have projected that the postal agency will continue to operate in the red for fiscal 2026. 
  • “At a USPS Board of Governors meeting on Thursday, Postmaster General David Steiner and the board reiterated their argument that legislative and administrative reforms, such as raising the postal agency’s $15 billion statutory debt limit, are necessary to reverse these losses.”

From the Food and Drug Administration front,

• Fierce Pharma reports,
  • “With online health and wellness company Hims & Hers opening a new front in the GLP-1 compounding showdown Thursday, the United States’ top drug regulator has taken notice.
  • “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” FDA commissioner Marty Makary, M.D., said in a Feb. 5 post on X. “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
  • “Makary’s comments mark a clear and sharp rebuttal to Hims’ announcement earlier in the day that it had launched a compounded version of Novo Nordisk’s new Wegovy (semaglutide) pill for obesity, which starts at just $49 per month.”
• and
  • “The FDA removed a prior “limitations of use” restriction it had placed on Gilead Sciences’ CAR-T Yescarta, allowing it to be used in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).
  • “Yescarta is approved for R/R large B-cell lymphoma, but previously wasn’t permitted to treat those with the rare, fast-growing PCNSL subtype. Prognoses related to this disease, which originates in the brain, spinal cord, eye, or cerebrospinal fluid, are typically poor, with a five-year survival rate of about 30%. The cancer type has no standard-of-care treatment options and an estimated 1,500 cases are diagnosed annually in the U.S.
  • “Dana-Farber Cancer Institute ran a phase 1 study to evaluate the safety of Yescarta in patients with PCNSL, as those with the disease had previously been excluded from the clinical trials supporting Yescarta’s initial approval, global head of development at Gilead’s Kite unit, Gallia Levy, M.D., Ph.D. explained in a company release.” 

• MedTech Dive relates,
  • “Johnson & Johnson is recalling certain Cerepak detachable coil systems due to a higher-than-expected failure to detach rate that has been associated with four serious injuries and one death. The events were reported as of Oct. 14.
  • “The failure to detach could result in hemorrhagic and ischemic stroke, procedural delays or the need for additional surgical intervention, according to the Food and Drug Administration, which posted the recall on Thursday.
  • “J&J issued a letter to customers on Oct. 2 recommending they remove certain Cerepak products from where they are used or sold.”

• Cardiovascular Business tells us,
  • “Zydus Pharmaceuticals, a New Jersey-based distributor of generic drugs, has recalled nearly 23,000 bottles of its icosapent ethyl capsules due to leakage issues that may have weakened their effectiveness. The prescription-strength capsules were manufactured by Softgel Healthcare in India and are sold in the United States as a more affordable option to name-brand treatment options.
  • “Icosapent ethyl is primarily used to help treat patients with high triglyceride levels in their blood. Taken together with a statin, it can also help significantly reduce the risk of heart attack, stroke or other cardiac complications in certain patient populations.
  • “Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” according to the Food and Drug Administration (FDA).”

From the judicial front,

• Fierce Healthcare reports,
  • “The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals.
  • “Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand. 
  • “The filing acknowledged the preliminary injunction plaintiffs had secured and the government’s failed bid to have the the temporary pause overturned by the appellate court. Both reflected judges’ belief that the hospitals were likely to succeed on the merits of their claims based on at least two administrative issues—”a failure to provide a reasonable explanation or address significant reliance interests and a failure to consider relevant costs.” 
  • “As such, HHS does not believe providing more administrative documents to the court would change any decisions, according to the joint motion.”

• The Wall Street Journal relates,
  • “Luigi Mangione will face murder and weapons charges in a Manhattan court in June for the killing of UnitedHealthcare CEO Brian Thompson, three months before jury selection in his federal trial for crimes related to the same killing.
  • “New York state court Judge Gregory Carro set a June 8 trial date during a snap hearing Friday, prompting an outburst from Mangione, who claimed he was being denied double-jeopardy protections.” * * *
  • “The Manhattan district attorney’s office argued the state case should go first because the killing occurred in Manhattan and local prosecutors—working with many NYPD detectives—led the investigation that resulted in Mangione’s arrest.
  • “The State has an overriding interest in trying this defendant for the cold-blooded execution of Brian Thompson on December 4, 2024. It resulted in the tragic death of a guest to our city on our streets,” Assistant District Attorney Joel Seidemann said in a letter to the judge.”

From the public health and medical / Rx research front,

• The Centers for Disease Control and Prevention announced today,
  • “Seasonal influenza activity remains elevated nationally with most areas of the country reporting stable or decreasing trends. Emergency department visits are stable and highest among children 5-17 years. Hospitalizations trends continue to decrease overall and are highest among those 65 years and older. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old.
  • “COVID-19
    • COVID-19 activity is elevated in some areas of the country.
  • “Influenza
    • “Seasonal influenza activity remains elevated nationally with most areas of the country reporting stable or decreasing trends; however, activity continues to increase in the Pacific Northwest.
    • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
  • “RSV
    • RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations are highest among infants less than 1 year old.
  • “Vaccination
    • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.

• The University of Minnesota CIDRAP adds,
  • “The effectiveness of this season’s flu vaccine in Canada is 40% against medically attended infection with influenza A(H3N2) viruses, 37% against newly emerged and predominant subclade K of the H3N2 strain, and 31% against the H1N1 influenza A strain, an interim analysis estimates.
  • “Researchers from the Canadian Sentinel Practitioner Surveillance Network (SPSN) conducted the test-negative study, which evaluated samples from patients aged one year or older who had acute respiratory illness. Community-based sentinel health care providers in Alberta, British Columbia, Ontario, and Quebec collected the specimens from October 26, 2025, to January 10, 2026, and the findings were published yesterday in Eurosurveillance.”

• The AP reports,
  • “During the early years of the COVID-19 pandemic, experts worried that disruptions to cancer diagnosis and treatment would cost lives. A new study suggests they were right.
  • “The federally funded study published Thursday by the medical journal JAMA Oncology is being called the first to assess the effects of pandemic-related disruptions on the short-term survival of cancer patients.
  • “Researchers found that people diagnosed with cancer in 2020 and 2021 had worse short-term survival than those diagnosed between 2015 and 2019. That was true across a range of cancers, and whether they were diagnosed at a late or early stage.
  • “Of course, COVID-19 itself was especially dangerous to patients already weakened by cancer, but the researchers worked to filter out deaths mainly attributed to the coronavirus, so they could see if other factors played a role.”

• Healio informs us,
  • “As the number of home hazards increased, so did the effect of visual function on the odds of falling.
  • “Home safety evaluations and environmental adaptations could be helpful for adults with low vision.”
• and
  • “Use of SGLT2 inhibitors was associated with lower 5-year risk for chronic kidney disease and AKI compared with GLP-1 receptor agonists for adults with type 2 diabetes, according to data published in JAMA Internal Medicine.”

• Radiology Business lets us know;
  • “New research suggests that photon-counting computed tomography scans outshine conventional contrasted chest CT for follow-up imaging of lung cancer. 
  • “Patients who have been diagnosed with the disease require routine imaging to monitor treatment effectiveness and ensure their cancer has not progressed or recurred. This is typically done via standard contrast-enhanced CT scans. Though effective, the standard of care comes with caveats, including increased exposure to both radiation and contrast media. What’s more, image quality can vary based on patient size, which can negatively affect lesion detection and characterization. 
  • “Experts believe that emerging photon-counting technology can help address these shortcomings. Published in RSNA’s flagship journal, Radiology, a new paper details numerous benefits photon-counting CT scans have over conventional CTs, including reduced radiation exposure and enhanced lesion visualization. Experts involved in the study went as far as to suggest that the advanced technology could replace conventional CTs in certain settings soon.”

• Genetic Engineering and Biotechnology News observes,
  • “If you zoomed in far enough on a new experimental HIV vaccine, you wouldn’t see the usual protein shell that most vaccines rely on. Instead, you’d find tiny geometric structures folded from strands of DNA—molecular origami designed not to be noticed at all. This “invisible” scaffold may be the key to awakening some of the rarest and most sought‑after cells in immunology: the B cells capable of maturing into broadly neutralizing antibody producers.
  • “Many next‑generation vaccines use virus‑like particles (VLPs)—nanostructures that mimic the outer shape of a virus but contain no genetic material. By displaying many copies of a viral antigen on their surface, VLPs can activate B cells far more effectively than free‑floating proteins. The paper is titled “DNA origami vaccines program antigen-focused germinal centers,” and was published recently in Science. 

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

• Fierce Healthcare reports,
  • “Centene is “laser-focused” on improving the performance of its Medicaid business following a difficult 2025.
  • “CEO Sarah London told investors Friday morning on the company’s earnings call that the team made headway in this effort in later part of 2025, with it’s Q4 medical loss ratio of 93% on par with expectations set for analysts in October and showing notable improvement from the second quarter of 2025.
  • “She said that utilization trend patterns seen in the third quarter largely carried into Q4, with behavioral health as the largest driver. Home health services and high-cost pharmaceuticals were also key factors in cost and utilization trends seen in the back half of the year, she said.
  • “And while a spike in flu and other respiratory illnesses generated headlines late in the year, London said that utilization patterns in its Medicaid population were on par with expectations.
  • “As an organization, we have been laser-focused on restoring our Medicaid business to sustainable profitability while maintaining our focus on quality outcomes for our members and the communities we serve,” London said.”
• and
  • “Molina Healthcare’s share price plunged on Friday as it posted a $160 million loss in the fourth quarter as well as guidance for 2026 that fell short of analysts’ expectations.
  • “Shares in the company were down by about 28% at 11:30 a.m. ET, with its stock tumbling out of the gate at market open on Friday. By comparison, Molina earned $251 million in profit for the fourth quarter of 2024.
  • “For the full year, Molina has posted $472 million in profit, down from $1.2 billion in 2024.
  • “In the earnings report, Molina revealed that it will exit the Part D space in the 2027 plan year due to financial pressure, including Medicare Advantage prescription drug (MAPD) plans. The company will focus on its existing dual-eligible business in Medicare, according to the announcement.”

• Healthcare Dive relates
  • “Primary care physicians spend a significant amount of time on work in their electronic health records, even when they decrease the number of appointments they schedule with patients, according to new research published in Health Affairs.
  • “Physicians who cut back appointments saw their visit volume decline by 32.6% compared with other doctors. But their EHR time fell by just 21.2% — meaning the number of minutes spent in their records systems actually increased per visit by more than 20%, according to the study. 
  • ‘Primary care physicians need to handle a lot of tasks outside appointments, like responding to patient messages, researchers wrote. So reducing visits doesn’t necessarily eliminate a host of EHR tasks — though it does have repercussions for physicians’ pay and patients’ access to care, they noted.” 
• and
  • “Epic rolled out an artificial intelligence tool this week that drafts clinical notes, setting up the nation’s largest electronic health record vendor as a major competitor in the ambient scribe market. 
  • “AI Charting, part of Epic’s AI tool called Art geared toward clinicians, listens during patients’ appointments with providers and can suggest orders based on the conversation. The product also allows clinicians to personalize the note’s structure using voice commands, like asking the tool to format current conditions as a bulleted list, according to a press release. 
  • “Epic plans to expand beyond documentation to make the tool “an active assistant in the room,” Corey Miller, Epic’s vice president of research and development, said via email. “This is really just the start for Art,” he said.”

• Fierce Healthcare adds,
  • “Infinitus has launched a new suite of agentic artificial intelligence tools for healthcare payers that aim to improve member engagement through personalized communications.
  • “Infinitus is an AI company that helps call centers better handle inbound call volumes. For payer organizations, pressured to control costs as call volumes rise and ratings of members demand a modern consumer experience, AI is positioned to solve both issues. 
  • “With the Agentic AI Member Services Suite, health plan members have 24/7 access to an AI agent that can answer simple administrative questions, onboard members, triage questions and navigate care. Through messaging and calling capabilities, Inifinitus’ AI agents can proactively reach out to patients and scale member services without adding team members.”
• and
  • “Aetna is continuing to build out its digital member experience with the launch of a new onboarding program designed to ease the process.
  • “The insurer said Thursday that the platform will be available to 4 million new members during the welcome period for their enrollment. The program leads on Rich Communication Services, or RCS, to support navigation and connect members with key information and resources they may need after enrolling in a new plan through text messaging.
  • “Nathan Frank, senior vice president and chief digital and technology officer for Aetna, told Fierce Healthcare that building trust with the member requires an end-to-end experience, and tech like the new onboarding program can play a key role in that effort.
  • “Onboarding isn’t just about administration and signing people up and making sure that you have the right information,” he said. “It’s the moment when members decide whether their health plan feels simple, or is it overwhelming?”