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  • Scientists awarded 2026 Nobel Prize for pioneering optogenetics light-switch technique
    The 2026 Nobel Prize in Physiology or Medicine was awarded to Karl Deisseroth, Peter Hegemann and Georg Nagel for their work on optogenetics, a technique that uses light to control neurons. The me…
    Fierce Biotech · 17d agoPositive↗ 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 · 17d agoPositive readoutNeutral↗ source
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  • 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 · 17d 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 · 16d 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 · 16d agoNeutral↗ source
  • Genentech pays Alector $100M for preclinical Parkinson’s prospect
    Genentech is paying Alector $100 million upfront for exclusive rights to a preclinical drug candidate that targets a driver of neurodegeneration in Parkinson’s disease.
    Fierce Biotech · 16d agoDealNeutral↗ 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 · 16d 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 · 17d 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 · 17d 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 · 17d 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 · 16d 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 · 16d 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 · 17d agoRegulatoryNeutral↗ source
  • Mimetic Medicines' peptide reduces pain-related sodium channels in mice, offering new neuropathic pain strategy
    Researchers at Mimetic Medicines tested a short lipidated peptide (SLiP) in mice and found it lowered the presence of Nav1.8 sodium channels on sensory neuron membranes. Reducing these channels hel…
    Fierce Biotech · 16d agoPositive readoutPositive↗ 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 · 16d agoRegulatoryNeutral↗ source
  • FDA issues request for information on early-phase ibogaine trial design
    The FDA announced a request for information (RFI) to gather input on how to design early-phase clinical trials of ibogaine drug products. The agency is looking for comments on protocol elements su…
    fda press · 16d 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 · 17d 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 · 17d 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 · 16d 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 · 16d 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 · 17d 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 · 17d agoNeutral↗ source
  • Novartis signs $7.8 billion deal with Abogen for mRNA-encoded autoimmune T-cell engager
    Novartis announced it will pay $575 million upfront to Abogen Biosciences for an mRNA-encoded T-cell engager that has shown early clinical activity in autoimmune disease. The agreement includes up…
    Fierce Biotech · 20d agoDealNeutral↗ source
  • BMO sees Merck better positioned than BMS to handle looming patent cliffs
    BMO Capital Markets says Merck has a stronger plan than Bristol Myers Squibb to replace revenue lost to upcoming patent expirations. The firm highlights Merck's pipeline as more derisked and sizabl…
    BioSpace · 19d agoNeutral↗ source
  • Pennsylvania reports fifth measles death as outbreak expands
    A recent report notes that Pennsylvania has recorded its fifth death linked to measles, underscoring the seriousness of the current outbreak in the state. Health officials are tracking the spread,…
    STAT · 19d agoNegative↗ source