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  • Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug
    Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
    Fierce Biotech · 18d agoCRLPositive↗ source
  • CMS GLP-1 pilot shows early uptake and health benefits for seniors, signaling broader weight-loss drug access
    CMS launched a federal pilot program to expand access to GLP-1 weight-loss medications for seniors. After about two months, early data show that enrollment is rising and participants report improv…
    Endpoints · 17d agoRegulatoryPositive↗ source
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  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 17d agoRegulatoryPositive↗ source
  • UK reduces drug rebate rate to 14.5% after a year of pharma pull-back, following US trade deal
    In September 2025, relations between the UK government and major pharmaceutical companies hit a low point when the government announced a steep increase in the share of sales of new branded medicin…
    Fierce Biotech · 17d agoRegulatoryNeutral↗ source
  • Moderna to raise $2 billion via convertible senior notes to fund oncology expansion and reduce debt
    Moderna announced it will issue $2 billion of convertible senior notes. The company says the financing will give it flexibility to invest in its growing oncology portfolio and to repay existing deb…
    Endpoints · 17d agoDealNeutral↗ source
  • Lonza appoints Samanta Cimitan as chief commercial officer as WuXi Biologics posts revenue surge
    Lonza said it will create a new chief commercial officer position and has selected Samanta Cimitan, the current chief executive of Celonic, to take the role on Jan. 1 next year. Cimitan will be re…
    Endpoints · 17d agoPositive↗ source
  • Vivace Therapeutics appoints Craig Gibbs as CEO and Ellen Lubman as chief business officer ahead of phase 3 mesothelioma trial
    Vivace Therapeutics announced two senior leadership appointments. Craig Gibbs, Ph.D., will serve as the company’s president and chief executive officer, while Ellen Lubman joins as chief business a…
    Fierce Biotech · 17d agoPositive↗ source
  • Osivax licenses GC Biopharma seasonal flu vaccine to develop combined OVX836-GC FLU shot
    Osivax has secured a non-exclusive license from GC Biopharma for its seasonal influenza vaccine, GC FLU, to pair with Osivax’s mid-phase candidate OVX836. OVX836 targets the conserved nucleoprotei…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Long-term unemployment pushes many biopharma professionals to quit job searches
    A recent BioSpace LinkedIn poll shows that about one-quarter of biopharma workers who have been unemployed for six months or more have stopped looking for new positions, and a similar share are con…
    BioSpace · 18d agoNegative↗ source
  • Scaling delivery is key for CAR T therapies to succeed in autoimmune diseases
    Biopharma companies are exploring CAR T cell therapies as a potential cure for autoimmune disorders, a market that could be twice the size of oncology. While current treatments manage symptoms, the…
    BioSpace · 18d agoNeutral↗ source
  • Akeso CEO says biliary tract cancer data could be a breakthrough
    Akeso’s chief executive Michelle Xia told ChinaPharma that the company’s PD-1xVEGF bispecific antibody, ivonescimab, is generating strong interest after early biliary tract cancer results. She not…
    Endpoints · 17d agoPositive↗ source
  • Metriport secures $26 million Series A to streamline doctor access to patient data
    Metriport, a health-tech startup focused on simplifying how physicians obtain patient information, announced a $26 million Series A financing. The round was led by Matrix, with participation from…
    Endpoints · 17d agoDealPositive↗ source
  • Generate Bio drops as data accidentally leaked ahead of European conference
    Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
    BioSpace · 17d agoRegulatoryNeutral↗ source
  • Generate:Biomedicines shares early Phase 1 respiratory data after ERS poster leak
    Generate:Biomedicines presented Phase 1 data for its respiratory disease candidate at the European Respiratory Society annual meeting. The presentation came after the conference posters were releas…
    Endpoints · 17d agoNeutral↗ source
  • Experts discuss hurdles and prospects for the first approved Fragile X therapy
    In a recent episode of BioSpace's "Denatured" podcast, Hilary Rosselot of the National Fragile X Foundation and Jordi Fàbrega, co‑founder and CEO of CONNECTA Therapeutics, talked about the current…
    BioSpace · 18d agoNeutral↗ source
  • Biopharma hiring gaps: experts cite four key mismatches between companies and candidates
    Recruiting specialists highlighted persistent disconnects between biopharma employers and job seekers, noting that misaligned expectations can slow hiring and discourage talent. One major issue st…
    BioSpace · 18d agoNeutral↗ source
  • Venture investor Redesign Health shifts from studio model to firm amid AI-driven startup boom
    AI is allowing founders to launch companies faster, challenging traditional venture studios that create ideas internally. Redesign Health, known for its studio approach, is changing its strategy,…
    Endpoints · 17d agoNeutral↗ source
  • FDA approves Revolution Medicines' Rasonque for metastatic pancreatic cancer
    Revolution Medicines received FDA approval for its oral RAS inhibitor daraxonrasib, branded as Rasonque, to treat patients with metastatic pancreatic adenocarcinoma who have already received prior…
    Fierce Biotech · 18d agoApprovalPositive↗ source
  • FDA grants early approval to RevMed's pancreatic cancer drug Rasonque
    FDA granted early approval to Revolution Medicines' daraxonrasib, now named Rasonque, for pancreatic adenocarcinoma, arriving 6.5 months before the FDA deadline. The oral RAS inhibitor demonstrate…
    BioSpace · 18d agoApprovalPositive↗ source
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 18d agoApprovalPositive↗ source
  • Summit Therapeutics and Akeso report Phase 3 survival benefit for ivonescimab in Chinese biliary tract cancer
    Summit Therapeutics and its Chinese partner Akeso said their bispecific antibody ivonescimab combined with chemotherapy improved overall survival for patients with first-line biliary tract cancer i…
    BioSpace · 18d agoPositive readoutPositive↗ source
  • Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancer
    The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gas…
    BioSpace · 18d agoApprovalPositive↗ source
  • FDA approves Revolution Medicines' daraxonrasib for second-line pancreatic cancer
    The U.S. Food and Drug Administration announced approval of Revolution Medicines' drug daraxonrasib for patients with pancreatic cancer who have already received prior therapy. The approval marks…
    Endpoints · 18d agoApprovalPositive↗ source
  • Biohaven secures up to $795 million partnership with SK Biopharma for global epilepsy drug rights
    Biohaven announced a commercial partnership for its late-stage epilepsy program. South Korea-based SK Biopharma has agreed to pay up to $795 million for worldwide rights to the company's Kv7 ion ch…
    Endpoints · 18d agoDealPositive↗ source
  • Hansoh says China’s biopharma is shifting from follower to frontrunner, now behind 30% of investigational drugs
    Hansoh Pharmaceutical used its first‑half earnings release to claim that China’s innovative biopharma sector is moving from a follower role to a frontrunner position. The company highlighted that…
    Fierce Biotech · 19d agoEarningsPositive↗ source