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  • Viking Therapeutics jumps 24% after Phase 1 obesity data, Longeveron falls 64% on mid-stage setback
    In September biotech stocks showed wide swings, with Viking Therapeutics gaining 24% and Longeveron dropping 64% as investors reacted to clinical data and trial setbacks. Viking reported Phase 1 r…
    BioSpace · 1mo agoPositive readoutNeutral↗ source
  • Utah moves forward with AI-driven acne prescription pilot, Nolla Health to test autonomous drug prescribing
    Utah regulators announced a plan to allow an artificial intelligence product to evaluate patients and generate drug prescriptions without prior human review. Nolla Health, a startup, will launch a…
    STAT · 1mo agoRegulatoryNeutral↗ source
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  • Biogen's litifilimab shows clear or almost clear skin in cutaneous lupus after one year
    Biogen reported that its experimental antibody litifilimab produced clear or almost clear skin in patients with cutaneous lupus erythematosus after one year of treatment in a mid‑stage study. The r…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Vaxcyte’s pneumococcal vaccine meets primary goals in Phase 3 trial, challenging Pfizer and Merck
    Vaxcyte announced that its experimental pneumococcal vaccine, VAX-31, achieved the primary endpoints in a pivotal Phase 3 study. The data, presented in a company release, show the shot met its pred…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Vaxcyte's experimental pneumococcal vaccine meets primary endpoints in Phase 3 trial
    Vaxcyte announced that its experimental pneumococcal vaccine, VAX-31, achieved the primary endpoints in a Phase 3 trial. The study enrolled just over 3,500 adults aged 50 and older who were random…
    STAT · 1mo agoPositive readoutPositive↗ source
  • 2026 Nobel Prize in Medicine awarded for optogenetics, the light-controlled brain research tool
    Karl Deisseroth, Peter Hegemann and Georg Nagel were named the 2026 Nobel laureates in Physiology or Medicine for their work on light-gated ion channels and the optogenetics technique. The Karolins…
    STAT · 1mo agoPositive↗ source
  • Rising Hospital and Drug Prices Drive Up Insurance Premiums for Workers and Employers
    Bob Herman’s investigation, based on interviews with more than twenty health policy experts and industry leaders, finds that soaring hospital and pharmaceutical prices are the primary force behind…
    STAT · 1mo agoNegative↗ source
  • Kyverna Therapeutics reports encouraging data for first CAR-T therapy targeting autoimmune disease
    Kyverna Therapeutics released new data that strengthens its case for bringing the first CAR‑T treatment for an autoimmune condition to market. The results come after recent safety setbacks in simil…
    BioSpace · 1mo agoPositive readoutNeutral↗ source
  • Roivant Sciences launches first solo drug, Lisraya, after FDA approval for dermatomyositis
    Roivant Sciences, which operates a hub-and-spoke subsidiary model, is stepping into the commercial arena with its inaugural solo product launch. The FDA has granted approval to the oral TYK2/JAK i…
    BioSpace · 1mo agoApprovalPositive↗ source
  • CSL strikes up to $1.6B deal with Alentis for autoimmune drug with broad potential
    CSL will co-develop and co-promote Alentis Therapeutics' anti-claudin-1 therapy lixudebart for kidney and liver conditions, including primary sclerosing cholangitis and a systemic autoimmune diseas…
    BioSpace · 1mo agoDealNeutral↗ source
  • 2026 Nobel Prize awarded to U.S. and German scientists for optogenetics breakthroughs
    The 2026 Nobel Prize in Physiology or Medicine was awarded to three researchers for their pioneering work on optogenetics. The laureates-Karl Deisseroth of Stanford University and the Howard Hughe…
    STAT · 1mo agoNeutral↗ source
  • Stem cell advocates anticipate FDA roundtables as peptide therapies gain regulatory foothold
    At PepMed 2026, a conference focused on peptide medicines, stem cell entrepreneur Chuck Meeker said he expects the FDA to hold a series of roundtables on regenerative therapies before year‑end. He…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Swiss CDMOs and CROs experience rapid growth as global sponsors seek specialized manufacturing and decentralized trials
    Switzerland’s contract development and manufacturing organisations (CDMOs) and contract research organisations (CROs) are entering a new boom cycle, driven by rising global demand for specialised m…
    BioSpace · 1mo agoDealPositive↗ source
  • FDA warns Evolus over misleading Instagram claims about Jeuveau
    The FDA's Office of Prescription Drug Promotion sent an untitled warning letter to Evolus, the maker of the injectable cosmetic product Jeuveau. The letter says the company exaggerated the drug’s…
    raps · 1mo agoRegulatoryNegative↗ source
  • Bayer to invest $2.2B in new Ohio manufacturing complex as FDA CDER opens clinical trial modernization office
    Bayer announced plans to spend roughly $2.2 billion on a new manufacturing site in Ohio, aiming to broaden its production capabilities. The investment is projected to increase capacity and generat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Staggering health insurance premiums force employers to rethink coverage options
    Employers are confronting staggeringly high health insurance premiums, according to a STAT+ newsletter by reporter Bob Herman. The piece highlights how rising costs are forcing some businesses to r…
    STAT · 1mo agoNegative↗ source
  • Will AI like Claude ever earn a Nobel Prize in medicine?
    Jeffrey S. Flier, a distinguished professor at Harvard and former dean of Harvard Medical School, writes an opinion piece prompted by the recent Nobel announcement. He asks whether an artificial-in…
    STAT · 1mo agoNeutral↗ source
  • FDA Requests Public Feedback on Designing Early-Phase Trials for Psychedelic Drug Ibogaine
    The U.S. Food and Drug Administration announced it is seeking comments from the public on how to structure early-phase clinical studies of ibogaine, a plant-derived psychoactive compound. The agen…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Federal Appeals Judges Reject HHS Arguments in Humana Medicare Advantage Audit Lawsuit
    Federal appeals judges on Monday rebuked the Health and Human Services Department's arguments in a hearing on Humana's lawsuit challenging a new Medicare Advantage audit rule. Humana, the nation's…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • ICU Medical updates IV tubing set instructions after reports of black specks in drip chambers
    ICU Medical has issued a final update letter recommending revised use instructions for several of its IV tubing sets after reports of black specks and particulate matter in the drip chambers. The…
    fda medwatch · 1mo agoRegulatoryNeutral↗ source
  • Australia's TGA begins five-year transition to new medicine labeling standards
    The Therapeutic Goods Administration has adopted two new labeling standards for medicines in Australia. The standards will become mandatory after a five-year transition period that starts now. Ph…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Two Massachusetts biotech firms shut down, ending cancer and eye‑disease programs
    Adecto Pharmaceuticals, a Boston‑based biotech developing a treatment for cancers resistant to standard immunotherapy, announced it has ceased operations as of September 30. CEO Nora Minerva shared…
    BioSpace · 1mo agoNegative↗ source
  • Energy drinks partner with college sports, raising safety concerns for teens
    Kent Sepkowitz, a professor emeritus at Weill‑Cornell Medical College, writes that energy drinks have grown into an $85‑billion global market and are now being marketed alongside college sports pro…
    STAT · 1mo agoNegative↗ source
  • Weighing the risks of CAR T in autoimmune disease as Kyverna nears market
    Not a month after reports of three deaths in autoimmune trials for Novartis' CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reporte…
    BioSpace · 1mo ago↗ source
  • Trump pledges $90 one-time Medicare Part B premium payment to over 20 million seniors before midterms
    President Donald Trump announced on social media that more than 20 million Medicare Part B enrollees will receive a one-time $90 payment to help cover their premiums. The promise comes days before…
    STAT · 1mo agoNeutral↗ source