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  • UK regulator suspends new patients from receiving Tavneos (Avacopan Vifor) amid data concerns
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to stop prescribing Tavneos, known locally as Avacopan Vifor, to any new patients. The decision follows the regulator’…
    BioSpace · 11d agoRegulatoryNegative↗ source
  • FDA vows tighter review of foreign clinical trial data amid rising Chinese influence
    Top FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…
    Endpoints · 10d agoRegulatoryNeutral↗ source
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  • UK regulator suspends Tavneos sales as MHRA follows EMA decision; UniQure files for Huntington's gene therapy approval
    The UK Medicines and Healthcare products Regulatory Agency has ordered a halt to the sale of the drug Tavneos, citing concerns that align with a recent decision by the European Medicines Agency. T…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • Teva's experimental antibody cuts intestinal damage in celiac patients after gluten challenge
    Teva reported that a single injection of an experimental antibody markedly lowered intestinal damage in participants with celiac disease who continued to consume gluten daily. The study was a glut…
    Endpoints · 10d agoPositive readoutPositive↗ source
  • UniQure submits experimental Huntington's gene therapy to FDA for accelerated review
    UniQure announced that it has filed its experimental gene therapy for Huntington's disease with the U.S. Food and Drug Administration, seeking accelerated approval. The submission follows earlier…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Novartis’ BTK inhibitor remibrutinib cuts MS relapse rates in Phase 3, setting up FDA filing
    Novartis reported that its BTK inhibitor remibrutinib, already approved for chronic spontaneous urticaria, lowered annualized relapse rates in two Phase 3 studies of relapsing multiple sclerosis wh…
    BioSpace · 11d agoPositive readoutPositive↗ source
  • Typewriter secures $56M to advance jumping-gene platform and in vivo CAR-T therapies
    Typewriter, a biotech startup, announced it has closed a $56 million financing round. The capital will be used to develop its jumping-gene platform, which seeks to deliver full genes without viral…
    Endpoints · 11d agoDealPositive↗ source
  • Trump’s new pharma deals lower Medicaid prices but shield Medicare from cuts
    Washington officials announced new voluntary pricing agreements with several midsize biotechnology companies. The deals require the firms to reduce the prices they charge under Medicaid, the progra…
    STAT · 11d agoDealNegative↗ source
  • Funding announcements can hint at upcoming biotech hiring opportunities
    Funding announcements serve as early signals that a biotech company may soon expand its workforce, giving job seekers a chance to reach out before roles are formally posted. Alex Benjamin, vice pr…
    BioSpace · 10d agoNeutral↗ source
  • Medical groups issue new flu, Covid and RSV vaccination guidance for upcoming winter season
    Professional organizations representing pediatricians, family physicians, obstetricians and other clinicians released joint vaccination guidelines on Wednesday for the upcoming respiratory illness…
    STAT · 10d agoNeutral↗ source
  • ARPA-H grants funding to biotech firms developing custom RNA therapies amid broader biotech updates
    ARPA-H is providing grants to several biotech companies to develop custom RNA therapeutics, aiming to accelerate personalized medicine. Roche has licensed a tri‑specific antibody, adding a new mod…
    STAT · 11d agoNeutral↗ source
  • Biotech reverse mergers surge 1,600% in Q3, matching number of IPOs in 2026
    Biotech companies are turning to reverse mergers as a faster, less volatile route to the public markets. In the third quarter of 2026, 17 reverse mergers were completed or announced, a 1,600% incre…
    BioSpace · 11d agoDealNeutral↗ source
  • ADA internal review refutes censorship and police involvement allegations after conference ejections
    The American Diabetes Association (ADA) completed an internal review following the removal of several members from its scientific sessions in New Orleans. The review concluded that there was no cen…
    STAT · 11d agoNeutral↗ source
  • Experts urge next DSM to consider algorithmic influence on eating disorders
    Jessica Scheer, CEO of the National Eating Disorders Association, and Riley Nickols, a sports psychologist, argue that the upcoming DSM revision, expected in 2030, must address how digital algorith…
    STAT · 11d agoNeutral↗ source
  • Former ARPA-H director launches startup to solve AI's basic challenges in health care
    A former director of the U.S. Advanced Research Projects Agency for Health has founded a new company focused on fixing what he calls the "dumb problems" of artificial intelligence in medicine. The…
    STAT · 11d agoNeutral↗ source
  • Ig Nobel Prizes move to Zurich as organizers cite US immigration concerns
    The Ig Nobel Prizes, a tongue-in-cheek science award, will be held outside the United States for the first time since they began in 1991. Organizers said the move to Zurich, Switzerland, reflects…
    STAT · 11d agoNeutral↗ source
  • Frutas y Hortalizas del Sur expands recall to include Great Value organic triple berry blend over possible E. coli O145 contamination
    On September 2, 2026, Frutas y Hortalizas del Sur S.A. announced that it is expanding the recall it issued on July 3, 2026 for frozen organic IQF blueberries. The expansion adds one lot of Great V…
    fda recalls · 10d agoCRLNegative↗ source
  • Novartis halts CD19 CAR-T trial after three deaths, Bristol Myers also pauses similar program
    Novartis announced a pause to its CD19-directed CAR-T cell therapy trials after three patients experienced fatal immune reactions. The company said the deaths were linked to a severe cytokine relea…
    Endpoints · 12d agoCRLNegative↗ source
  • Novartis and BMS pause CAR-T trials after fatal immune syndrome cases
    Novartis has halted several immunology and neurology studies of its CAR T candidate rapcabtagene autoleucel after three patients experienced fatal immune effector cell‑associated hemophagocytic syn…
    BioSpace · 12d agoRegulatoryNegative↗ source
  • Roche partners with China's Simcere Zaiming on $1.5 billion T-cell engager for B-cell diseases
    Roche announced a licensing agreement with Simcere Zaiming, a subsidiary of China's Simcere Pharmaceutical Group, to develop a trispecific T-cell engager called SIM0660. The deal includes an upfro…
    BioSpace · 11d agoDealPositive↗ source
  • GSK to begin Phase 3 trial of mRNA seasonal flu vaccine after strong Phase 2 results
    GSK announced it will start a Phase 3 study of its mRNA vaccine targeting seasonal influenza. The move follows Phase 2 data that showed the candidate produced higher immune responses than traditio…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • Novartis reports positive multiple sclerosis results with its BTK inhibitor
    Novartis announced that its BTK inhibitor has shown a positive outcome in a multiple sclerosis study, marking a notable advance for the company in this therapeutic area. The result highlights the…
    STAT · 12d agoPositive readoutPositive↗ source
  • Novartis' Rhapsido shows safety edge and relapse reduction in Phase 3 multiple sclerosis trials
    Novartis reported results from two identical Phase 3 studies of its BTK inhibitor Rhapsido in patients with multiple sclerosis. The trials showed the oral pill lowered the annualized relapse rate…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • ARPA-H grants up to $125M to accelerate on-demand custom RNA therapy manufacturing
    ARPA-H announced a new funding initiative aimed at speeding the creation of personalized RNA medicines. The agency will provide up to $125 million in total awards. Five research groups were select…
    Endpoints · 11d agoDealPositive↗ source
  • Eli Lilly's 2026 acquisitions boost over 50 biotech venture investors
    Eli Lilly announced its thirteenth acquisition of 2026, continuing a busy year of dealmaking for the drugmaker. The transactions have involved at least fifty different venture capital firms, sendi…
    Endpoints · 11d agoDealPositive↗ source