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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 · 1mo agoApprovalPositive↗ source
  • CSL agrees $355M upfront deal to co-develop Alentis anti-fibrosis drug for kidney and liver
    CSL, an Australian drugmaker, announced a partnership with Alentis Therapeutics that includes a $355 million upfront payment. Under the agreement, CSL will co-develop Alentis's anti-fibrosis candi…
    Endpoints · 1mo agoDealNeutral↗ source
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  • FDA delays review of Novo's hemophilia A drug denecimig over factory issues
    US regulators have extended the review of Novo's hemophilia A injection, denecimig, because of problems at an unnamed manufacturing facility. The FDA said ongoing remediation activities observed d…
    Endpoints · 1mo agoRegulatoryNegative↗ 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
  • 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 · 1mo 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 · 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
  • 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • Genentech parts ways with global AI head Richard Bonneau
    Genentech, the Roche biotech unit, announced that its global head of artificial intelligence for drug discovery, computational biologist Richard Bonneau, has left the company effective immediately.…
    Endpoints · 1mo agoNegative↗ 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 · 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
  • Report highlights 20 women reshaping biopharma across oncology and rare disease fields
    The 2026 special report spotlights twenty women who are driving change in biopharma, covering areas such as oncology and rare diseases. The series, now in its eighth year, has recognized over 160…
    Endpoints · 1mo agoPositive↗ 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
  • Eli Lilly reports strongest weight-loss data yet; Sanofi and Regeneron secure $1 billion upfront deal
    The weekly Endpoints newsletter dated October 3, 2026 highlights that Eli Lilly's latest weight‑loss trial produced its best‑ever results. While the article does not provide specific numbers, the…
    Endpoints · 1mo agoDealNeutral↗ 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 · 1mo agoDealNeutral↗ source