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1,517 stories matching this filter · ← front page

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  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Investors increase stakes in Bain-backed biotech startup as FDA gene‑therapy chief departs
    Investors are putting more money into a biotech startup backed by private‑equity firm Bain Capital, according to the STAT+ newsletter. Vijay Kumar is leaving his role as acting director of the FDA…
    STAT · 1mo agoDealNeutral↗ source
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Infectious Disease374
  • US lawmakers probe Chinese clinical trial sites for potential military links involving major drugmakers
    A bipartisan group of U.S. lawmakers has launched a national‑security investigation into whether several large pharmaceutical companies participated in clinical trials at Chinese sites that may hav…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Trump drug deal with Eli Lilly and Novo Nordisk has loophole allowing higher GLP-1 volumes without price cuts
    The Trump administration negotiated a "grand bargain" with drugmakers that promised lower Medicare and Medicaid prices for GLP‑1 drugs in exchange for higher sales volume. Eli Lilly and Novo Nordi…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Abivax's new ulcerative colitis data eases safety worries, sending shares up 25%
    Abivax released additional data on its experimental ulcerative colitis drug obefazimod. Earlier trial results had shown strong efficacy but raised safety concerns after several cancer cases were r…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Anthropic launches Claude Science AI platform tailored for pharmaceutical research
    Anthropic announced the availability of Claude Science, an AI application built on its large language model and aimed at scientific laboratories and pharmaceutical research. The tool is intended t…
    STAT · 1mo agoPositive↗ source
  • Biotech firms raise record funds in 2026, with $2.1 bn round for Isomorphic Labs
    After a few slow years, the biotech financing landscape is showing signs of recovery, though investors remain cautious about where they place capital. A recent PharmaVoice reader poll found that 2…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • FDA digital chief signals upcoming AI regulatory guidance
    STAT+ health-tech newsletter reported that the FDA’s digital leader offered a preview of forthcoming guidance on artificial intelligence. The briefing, delivered by Rick Abramson, highlighted the a…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Half of U.S. states file lawsuits challenging Medicaid work-requirement rules
    A coalition of states has filed legal challenges against recent Medicaid work‑requirement policies, arguing that the rules threaten access to health coverage for low‑income residents. The lawsuits…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Trump administration downplays alcohol risks, hindering efforts to curb drinking-related harms
    A STAT investigation reported that the Trump administration has downplayed the health risks of alcohol and has taken steps that obstruct research into drinking-related harms. Although alcohol is r…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Rep. Tom Kean Jr. Discloses Depression Diagnosis After Four-Month Congressional Absence
    Rep. Tom Kean Jr., a Republican congressman from New Jersey, announced on the House floor that he has been receiving treatment for depression, which explains his unexplained four-month absence from…
    STAT · 1mo agoNeutral↗ source
  • Florida mandates EKGs for high-school athletes, but the new law may cause stress and cost
    Florida has become the first state to require electrocardiograms for high‑school athletes before they can participate in sports. The law is intended to screen for hidden heart conditions that could…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Student loan cap policy favors chiropractic over critical health professions, warns surgeon
    David S. Shapiro, a board-certified surgeon and physician executive, argues that the Education Department's new student-loan limits miss the realities of modern health care. The rule caps annual f…
    STAT · 1mo agoRegulatoryNegative↗ source
  • 26 states file lawsuit to halt federal Medicaid work-requirement rule
    Five New England states joined 21 others in a lawsuit filed Monday to stop a federal rule that would add work requirements to Medicaid. The states argue the new guidelines create an unfair bureaucr…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA adds peptide-focused physicians to advisory panel, raising conflict-of-interest concerns
    The FDA announced eight new members for a committee that will advise on whether compounding pharmacies can produce certain peptides. Most of the appointees are physicians or pharmacists who run bu…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • 5 takeaways from STAT’s investigation into microhospital operator Nutex Health
    Read the takeaways from STAT's investigation into Nutex, which used the No Surprises Act to fuel a stunning financial turnaround.
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA’s top gene-therapy regulator Vijay Kumar steps down amid leadership shake-up
    Vijay Kumar, the acting director of the FDA office that reviews cell and gene therapies, has announced he will leave his position. In an email to staff, Kumar said he reflected on his tenure and de…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • AstraZeneca to Pay $34 Million Settlement Over Texas Medicaid Kickback Allegations
    AstraZeneca has agreed to a $34 million settlement with the Texas attorney general over allegations that it provided improper incentives to boost prescriptions covered by Texas Medicaid. The state…
    STAT · 1mo agoRegulatoryNegative↗ source
  • California hospital lawsuits reveal forced McKinsey ties and surprise ER chain profits
    Unredacted comments from recent California hospital lawsuits show that hospital executives admitted to a "forced" partnership with consulting firm McKinsey, raising questions about the influence of…
    STAT · 1mo agoRegulatoryNegative↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • FDA accepts Replimune filing; Merck KGaA drops $11B on life sciences services
    Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicines outlined more RAS-blocking data and a Definium stock offering brought in $800 million.
    BioPharma Dive · 2mo ago↗ source
  • At BIO, tension over China biotech deal regulation looms
    Biotech investors, executives and analysts worry that blanket bans on deals with Chinese companies could curb domestic entrepreneurs’ ambitions in the sector.
    BioPharma Dive · 2mo ago↗ source
  • Alkermes’ incoming CEO has a plan to outplay Lilly and Takeda
    Blair Jackson says the next 12 months may be the most important in Alkermes’ history, as the brain drugmaker races to join an “orexin” market that analysts see as a multibillion-dollar opportunity.
    BioPharma Dive · 2mo ago↗ source
  • On second try, Acadia drug gets nod from European regulators
    The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.
    BioPharma Dive · 2mo ago↗ source