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  • Biotech Index Retraces Gains as Weak Trial Data and Market Fears Weigh
    BioPharma Dive’s latest data‑visualization piece examines why biotech stocks have slipped recently and highlights the rapid pace of startup acquisitions this year. The XBI index, a barometer for b…
    BioPharma Dive · 12d agoNeutral↗ source
  • CBER Director Karim Mikhail Aims to Restore Stability After Turbulent Leadership Changes
    The FDA's Center for Biologics Evaluation and Research (CBER) is working to regain stability after a period of rapid leadership turnover. Karim Mikhail, who was confirmed as the permanent director…
    Fierce Biotech · 12d agoRegulatoryPositive↗ source
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  • TRexBio and Retension raise $161.7M in IPOs as biotech fundraising surge continues
    TRexBio and Retension Pharmaceuticals are slated to begin trading on Friday, together raising $161.7 million. Their offerings push the number of biotech IPOs this year to 29, underscoring a continu…
    BioSpace · 12d agoDealPositive↗ 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 · 12d agoRegulatoryNegative↗ source
  • GSK partners with Chai Discovery to use AI protein-folding models after successful wet-lab tests
    GSK has entered a collaboration with Chai Discovery, a biotech firm that offers AI‑driven protein folding and design tools. The agreement gives GSK access to Chai's models, which were reported to…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Pfizer signs $500M deal with Enodia to develop Sec61 protein degraders
    Pfizer has entered a licensing and research collaboration with Enodia Therapeutics, valued at up to $500 million, to discover and develop inhibitors of the Sec61 protein‑translocation channel. The…
    Fierce Biotech · 12d agoDealNeutral↗ 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 · 12d agoRegulatoryNegative↗ source
  • Fierce Biotech outlines criteria for its 2026 Fierce 15 list, spotlighting top innovators
    The Fierce Biotech editorial team released its 2026 Fierce 15 list and discussed the selection process on a recent episode of "The Top Line" podcast. More than 150 high‑quality entries were review…
    Fierce Biotech · 12d agoPositive↗ source
  • Nobel-winning optogenetics sees growing biotech interest
    Karl Deisseroth, a Stanford psychiatrist and bioengineer, learned he had shared the 2026 Nobel Prize in Physiology or Medicine for pioneering optogenetics, a method that makes neurons responsive to…
    Fierce Biotech · 12d agoPositive↗ 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 · 12d agoRegulatoryNeutral↗ source
  • TRex Bio prices $117M IPO to fund Treg-targeted immune therapies
    TRex Bio announced pricing of its initial public offering at $117 million, selling 8,333,334 shares at $14 each, meeting the low end of its earlier guidance. The company will begin trading on Nasd…
    BioPharma Dive · 12d agoDealPositive↗ 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 · 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
  • BD appoints Ferass Abuzaina as Worldwide President of Surgery
    Becton, Dickinson and Company announced that Ferass Abuzaina will serve as the new Worldwide President of its Surgery business unit, effective immediately. He will oversee the global strategy, oper…
    Fierce Biotech · 12d agoPositive↗ source
  • 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 · 12d 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 · 12d 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 · 12d agoNegative↗ source
  • Endeavor BioMedicines reports positive phase 2b results for Hedgehog inhibitor taladegib in IPF
    Endeavor BioMedicines announced that its Hedgehog pathway inhibitor, taladegib, produced encouraging results in a phase 2b study of patients with idiopathic pulmonary fibrosis (IPF). The trial, nam…
    Fierce Biotech · 13d agoPositive readoutPositive↗ 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 halts late-stage Vyvgart trial in Sjogren’s disease after futility finding, shares tumble 13%
    Argenx announced it is ending the Phase 3 UNITY trial of its Vyvgart Hytrulo injection in Sjogren’s disease after an independent data monitoring committee concluded the study would not meet its pri…
    BioSpace · 12d agoNegative readoutNegative↗ 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 · 13d agoNegative readoutNegative↗ source