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  • FDA reprimands Lundbeck Seattle Biopharmaceuticals for inflated claims on Vyepti migraine webpages
    The U.S. Food and Drug Administration issued an untitled letter to Lundbeck Seattle Biopharmaceuticals criticizing two promotional webpages about its migraine treatment Vyepti. The agency said the…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • GSK ends $2.2 billion brain drug partnership with Alector after trial failures
    GSK and California‑based biotech Alector have ended their collaboration after both experimental brain drugs failed to meet development milestones. The partnership, announced in July 2021, gave GSK…
    BioPharma Dive · 1mo agoDealNegative↗ source
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  • FDA pauses public release of Complete Response Letters to limit litigation risk
    The FDA announced it has temporarily halted the routine public posting of Complete Response Letters (CRLs), which are letters sent to drug sponsors when the agency does not approve a marketing appl…
    Endpoints · 1mo agoCRLNeutral↗ source
  • Michigan sees nearly 1,000 cyclospora cases, the state's largest outbreak and among the nation's biggest
    Nearly a thousand residents of Michigan have been diagnosed with a cyclospora infection that causes prolonged watery diarrhea, making it the biggest outbreak in the state's history and one of the l…
    STAT · 1mo agoNeutral↗ source
  • ARPA-H launches $160 million THRIVE program to fund seven labs developing custom gene-editing therapies for rare diseases
    ARPA-H, the U.S. Advanced Research Projects Agency for Health, announced a new initiative called THRIVE with up to $160 million in funding. The program will support seven research teams over five…
    STAT · 1mo agoPositive↗ source
  • Ipsen's Dysport shows positive Phase 3 results in migraine, Tarsus acquires iRenix for $75M
    Ipsen reported that its injectable neurotoxin Dysport met the primary endpoint in a Phase 3 trial aimed at reducing monthly migraine days. The trial demonstrated a statistically significant reduct…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Prime Secures Arbitration Victory Over Beam, Paving Way for Clinical Trials
    Prime, a biotech firm developing a gene‑therapy candidate, won an arbitration case against Beam Therapeutics. The ruling removes a legal hurdle and allows Prime to advance its program into clinical…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • White House reviews three candidates to lead the FDA
    STAT+ reports that the White House is currently evaluating three leading candidates to become the next head of the Food and Drug Administration. The review process is part of the administration's e…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Mid-year roundup highlights top health-tech trends in 2026
    The editorial team notes that the first half of 2026 has been unusually active for health technology. Five major developments have been identified as the most significant so far. One clear theme i…
    Endpoints · 1mo agoNeutral↗ source
  • Catalent to sell its Nottingham oral solid dose facility to CDMO Codis
    Catalent announced it will divest its United Kingdom manufacturing site, selling the oral solid dose factory located in Nottingham. The buyer is Codis, a contract development and manufacturing org…
    Endpoints · 1mo agoDealNeutral↗ source
  • Podcast discusses health insurance costs, whistleblower case, and potential FDA commissioner picks
    The Readout LOUD podcast episode explores why employer-provided family health insurance can be as expensive as a new car. The hosts interview a whistleblower who challenged an insurance contractor…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about FDA commissioner contenders, a heart drug failure, and more
    The White House is reviewing a list of three top contenders for the FDA commissioner post
    STAT · 1mo ago↗ source
  • STAT+: OpenEvidence backs study that finds it beats LLMs
    In this edition of STAT Health Tech: Dueling research pitting OpenEvidence against general purpose LLMs, use of Dexcom's CGM in children, and more.
    STAT · 1mo ago↗ source
  • HHS plan to speed drug research won’t remove ‘self-inflicted’ delays
    U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?
    BioPharma Dive · 1mo ago↗ source
  • AstraZeneca, Ionis drug fails big heart disease study in major setback
    Eplontersen’s failure in transthyretin-mediated amyloidosis cardiomyopathy caught Wall Street analysts by surprise and boosted the outlook of rival drugs from Alnylam and BridgeBio Pharma.
    BioPharma Dive · 1mo ago↗ source
  • Who’s going to run the FDA?
    RFK Jr.'s list of Covid vaccine injuries, a father's quest to cure his daughter, and more health news from Morning Rounds
    STAT · 1mo ago↗ source
  • GSK walks away from Alector pact as immuno-neurology bet fizzles
    After two high-profile trial failures over the past year, GSK is breaking off a deal that features $700 million upfront that it signed with Alector for neurodegenerative disease treatments. GSK’s e…
    Endpoints · 1mo ago↗ source
  • STAT+: 931 days. The drug approval scandal hiding in plain sight
    Two years, six months, and 18 days have elapsed since Northwest Biotherapeutics submitted its brain cancer treatment for regulatory approval.
    STAT · 1mo ago↗ source
  • STAT+: AstraZeneca, Ionis report major trial failure with heart disease drug
    AstraZeneca and Ionis reported a notable trial failure Thursday in a heart disease that's become an increasingly competitive market for drugmakers.
    STAT · 1mo ago↗ source
  • Opinion: Your grandparents are using cannabis. Doctors can help them do it safely
    Over the past 25 years, I have treated thousands of medical cannabis patients with extremely few ill effects, one doctor writes.
    STAT · 1mo ago↗ source
  • Opinion: Who benefits from classifying obesity as a disease?
    “The new wave of obesity pharmacotherapy has leaned heavily on disease framing,” writes Max Moser, drawing comparisons to the antidepressant revolution.
    STAT · 1mo ago↗ source
  • STAT+: The quest to save Grace — and clear the way for rare disease patients everywhere
    How a father’s quest may shape the future of rare disease gene therapy.
    STAT · 1mo ago↗ source
  • What happens on ‘MAHA Monday’?
    STAT's Alex Hogan and Chelsea Cirruzzo stopped by "MAHA Monday" at the Great American State Fair. Watch their report in this week's STATus Report.
    STAT · 1mo ago↗ source
  • Updated: AstraZeneca sinks on unexpected heart drug trial failure
    AstraZeneca’s shares dropped in early trading Thursday after a heart disease treatment it is developing with Ionis Pharmaceuticals surprisingly failed in a late-stage trial. The companies had aimed…
    Endpoints · 1mo ago↗ source