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  • Roche signs $100 million upfront deal with Alector to advance Parkinson's research
    Roche announced a partnership with biotech Alector focused on neuroscience and Parkinson's disease, providing an upfront cash payment of $100 million. The agreement aims to combine Roche's resourc…
    Endpoints · 1mo agoDealPositive↗ source
  • 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
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  • 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
  • Nobel prize honors scientists who pioneered light-activated gene therapy technology
    Three researchers received this year’s Nobel Prize in medicine for creating optogenetics, a technique that uses light to steer nerve activity. The award recognizes their foundational work that has…
    Endpoints · 1mo agoPositive↗ source
  • Sensible Bio raises $47 million Series A to build mRNA therapy manufacturing platform
    Sensible Biotechnologies announced it has closed a $47 million Series A financing round. The capital will be used to develop its proprietary manufacturing platform for mRNA based therapies. The fu…
    Endpoints · 1mo agoDealPositive↗ source
  • Epicrispr reports encouraging early data from EPI-321 in 12 patients with FSHD
    Epicrispr Biotechnologies released updated data on its epigenetic editing therapy EPI-321 aimed at treating facioscapulohumeral muscular dystrophy (FSHD). The company has now dosed twelve particip…
    Endpoints · 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
  • 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 · 1mo 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 · 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 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
  • 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