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  • 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 · 12d 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
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  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 12d agoRegulatoryNegative↗ 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
  • Argenx shares tumble 15% after Phase 3 Sjögren’s study of Vyvgart halted for futility
    Argenx reported that an independent monitoring board recommended stopping its Phase 3 trial of Vyvgart in Sjögren’s disease due to futility, based on an interim analysis. The decision came earlier…
    BioPharma Dive · 12d agoNegative readoutNegative↗ 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
  • Viatris to acquire Pacira BioSciences for $1.65 billion, adding two non-opioid pain drugs
    Viatris announced Thursday it will purchase Pacira BioSciences for $1.65 billion in cash, paying $36.50 per share, a 45% premium to the prior close. The acquisition gives Viatris control of Pacira…
    BioPharma Dive · 12d agoDealPositive↗ 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 · 13d 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
  • PhRMA sues Trump administration over Medicare price linking pilot program
    The pharmaceutical trade group PhRMA has filed a lawsuit against the Trump administration, challenging a pilot program that would tie Medicare drug prices to the levels seen in peer countries. The…
    STAT · 12d agoRegulatoryNegative↗ source
  • EU Commission urges EMA to fast-track Biotech Act preparations
    The European Commission has issued a statement urging the European Medicines Agency to accelerate work on the upcoming Biotech Act, which aims to streamline regulation of advanced therapies. The C…
    raps · 13d agoRegulatoryNeutral↗ source
  • Trump administration probes nine top universities over alleged J-1 visa misuse for postdocs
    The Trump administration announced an investigation into nine universities for alleged misuse of J-1 visas that support postdoctoral researchers. The schools named include Harvard, Yale, Stanford,…
    STAT · 12d agoRegulatoryNegative↗ source