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  • FDA flags safety concern after four deaths in schizophrenia drug trial
    The U.S. Food and Drug Administration issued a warning after four participants died while receiving an experimental treatment for schizophrenia in a clinical study. The agency described the observ…
    STAT · 11d agoRegulatoryNegative↗ source
  • Hospitals file second lawsuit to block Trump admin's 340B rebate pilot
    The American Hospital Association (AHA) has filed another lawsuit against the federal government, challenging a new version of the 340B drug discount program proposed by the Trump administration.…
    STAT · 11d agoRegulatoryNegative↗ source
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  • Pharma gifts and payments to doctors linked to higher inappropriate prescribing, study finds
    A Cochrane review of dozens of prior studies found that gifts and payments from drug makers to physicians lead to more inappropriate prescribing and a higher total number of prescriptions, which li…
    STAT · 11d agoNegative↗ source
  • Proposed Census Overhaul Could Undermine Public Health Data, Experts Warn
    Federal officials are proposing three major revisions to the U.S. Census. The plan would drop questions on race, ethnicity and sexual orientation and would count only U.S. citizens, leaving out non…
    STAT · 11d agoRegulatoryNegative↗ source
  • Proposed US Census rule changes could distort health data, warns epidemiologist
    Nancy Krieger, a professor of social epidemiology at Harvard T.H. Chan School of Public Health, wrote an opinion piece warning that proposed changes to the U.S. decennial census could have severe p…
    STAT · 11d agoRegulatoryNegative↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 11d agoRegulatoryNeutral↗ source
  • Study finds rising patent thickets may slow generic drug competition
    A recent special communication in JAMA reports that the number of patents linked to FDA‑approved small‑molecule drugs has risen over the past 15 years. The increase is driven largely by non‑primary…
    raps · 11d agoNeutral↗ source
  • Humana tops 2027 Medicare Advantage star ratings as insurers face $13 billion in bonus payouts and legal challenges
    The Centers for Medicare & Medicaid Services released the 2027 star ratings for Medicare Advantage plans, with Humana emerging as the top‑scoring insurer. Plans that achieve at least four out of f…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Biotech executive Steven Quay dropped from consideration for NIAID director role
    Steven Quay, a biotech executive known for promoting the lab‑leak theory, was reportedly in the running to lead the National Institute for Allergy and Infectious Diseases. A source familiar with t…
    STAT · 11d agoNeutral↗ source
  • Life Biosciences injects experimental cellular reprogramming drug into three glaucoma patients, reports no serious adverse events
    Life Biosciences provided an update on its early‑stage glaucoma study involving its experimental cellular reprogramming therapy. The company said three patients have each received a single intravi…
    STAT · 11d agoPositive readoutPositive↗ source
  • Researcher uses Reddit data to map post-Roe abortion access barriers
    Betsy Pleasants, a postdoctoral researcher at the Center for Women’s Health Research, began studying how the Covid‑19 pandemic affected abortion services while a graduate student at UC Berkeley. W…
    STAT · 11d agoNeutral↗ source
  • Q32 Bio appoints José Trevejo as chief medical officer, coming from Enveda Therapeutics
    STAT+ ran its regular "up and down the ladder" column highlighting recent personnel moves in the pharma sector. The feature invites readers to share hiring, promotion and departure news for broader…
    STAT · 11d agoNeutral↗ source
  • MAHA movement fades as midterms approach, lacking visibility and funding
    Health secretary Robert F. Kennedy Jr.'s Make America Healthy Again (MAHA) movement entered the political arena promising to rally an unlikely coalition of activists and deliver significant gains f…
    STAT · 11d agoNegative↗ source
  • Roche partners with Chinese biotech Defand Therapeutics to co-develop new medicines
    Roche announced a partnership with Chinese biotech startup Defand Therapeutics aimed at joint discovery of new drug candidates. Unlike the typical licensing deals where companies obtain rights to…
    STAT · 12d agoDealPositive↗ source
  • Argenx's Vyvgart fails to beat placebo in Phase 3 Sjögren's disease trial
    Argenx announced that its marketed antibody therapy Vyvgart did not show superiority over placebo in a Phase 3 study involving patients with Sjögren's disease, a chronic autoimmune condition. The…
    STAT · 12d agoNegative readoutNegative↗ source
  • Roche partners with China's Defand Therapeutics to discover molecular glue medicines
    Roche announced a collaboration with Chinese biotech Defand Therapeutics aimed at discovering new molecular glue medicines for oncology and immune‑mediated diseases. Unlike typical licensing deals…
    STAT · 12d agoDealPositive↗ source
  • CMS proposes changes to curb 340B drug discount program’s costly subsidies to safety-net hospitals
    Casey B. Mulligan, chief economist and chief regulatory officer at HHS, wrote an opinion piece outlining a major flaw in the 340B drug discount program. The program, created in 1992, gives steep di…
    STAT · 12d agoRegulatoryNegative↗ source
  • NIH funding uncertainty clouds US research, dampens biotech investor sentiment
    The latest episode of STAT’s “The Readout LOUD” podcast examined how the National Institutes of Health is allocating its budget and the growing uncertainty surrounding future funding. Hosts Elaine…
    STAT · 12d agoNegative↗ source
  • FDA extends safety review of mifepristone into next year, report due by March 2027
    The FDA announced that its ongoing safety evaluation of mifepristone, the primary medication used for medical abortions, will not be completed until next year. The agency expects to finish the saf…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Tailored breast cancer care for older women gains momentum as researchers highlight age-specific tumor differences
    Older women represent a large share of breast cancer diagnoses, with nearly half of cases occurring in patients 65 or older and about one-fifth in those 75 and older. Despite these numbers, clinic…
    STAT · 12d agoPositive↗ source
  • Everlywell launches AI tool to predict breast cancer risk directly to consumers
    Everlywell, a digital health company known for offering at-home lab tests, has introduced a new artificial intelligence algorithm that evaluates breast cancer risk from medical images. The company…
    STAT · 12d agoPositive↗ source
  • Experts say U.S. must step up to match Europe’s progress in eliminating hepatitis C
    The authors argue that England and several other nations are nearing hepatitis C elimination, while the United States lags behind. They point to recent public attention, such as Pamela Anderson’s…
    STAT · 12d agoNeutral↗ source
  • Smaller biotech firms face uncertainty over U.S. tariff exemptions as new import taxes take effect
    A broad 100% tariff on imported pharmaceuticals introduced at the end of September under the Trump administration has created confusion for many biotech companies. While large drugmakers can use e…
    STAT · 12d agoRegulatoryNegative↗ source
  • FDA unveils transparency roadmap with plans for public NDA/BLA disclosures and inspection report publishing
    The FDA published a transparency roadmap that outlines its FY 2026 achievements and sets out priorities for FY 2027. One key priority is a proposal to require public disclosure of new drug applica…
    raps · 12d agoRegulatoryNeutral↗ source
  • Congressional Bill Aims to End Arbitration in No Surprises Act, Shifting Payments to Median In-Network Rates
    Rep. Frank Pallone introduced the Lower Premiums, Faster Payments Act, which would eliminate the arbitration system used under the No Surprises Act and replace it with a payment model based on medi…
    STAT · 12d agoRegulatoryNeutral↗ source