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  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 16d agoApprovalPositive↗ source
  • Fifth Circuit Court rejects pharma industry's challenge to Medicare negotiation rules
    The Fifth Circuit Court of Appeals issued a ruling that ends the pharmaceutical industry's legal effort to overturn Medicare's negotiation framework. The court denied the industry's request, markin…
    Endpoints · 16d agoRegulatoryNegative↗ source
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  • Eli Lilly stops disclosing Phase 1 pipeline, prompting mixed reactions
    Eli Lilly announced that it will no longer publicly share details of its Phase 1 drug candidates. The policy shift comes as the company’s GLP-1 product continues to generate the highest sales among…
    Endpoints · 16d agoNeutral↗ 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 · 16d agoRegulatoryPositive↗ source
  • 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 · 16d agoRegulatoryPositive↗ source
  • Outer Bio unveils skin‑tissue platform that keeps samples alive for a month, creating terabytes of data for skincare research
    Outer Bio, a new biotech founded by Michael Polansky, has emerged from stealth to offer a skin‑focused platform that maintains harvested human skin tissue alive for about a month. The company says…
    BioPharma Dive · 16d agoPositive↗ 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 · 16d 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 · 16d agoPositive↗ 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 · 16d 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 · 16d agoNeutral↗ source
  • Medtronic and Given Imaging issue early alert for Bravo CF esophageal pH capsule delivery devices due to attachment failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert about a potential high‑risk issue with Medtronic’s Bravo CF esophageal pH monitoring capsule delivery devices. The proble…
    fda medwatch · 16d agoRegulatoryNegative↗ 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 · 16d 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 · 16d agoDealPositive↗ source
  • AVID Medical issues correction for convenience kits containing recalled Medline Namic Star Off-Handle manifolds
    AVID Medical has sent a letter to customers directing a correction of certain convenience kits that include manifolds affected by the Medline Namic Angiographic Star Off-Handle manifold recall. Th…
    fda medwatch · 16d agoCRLNegative↗ 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 · 16d 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 · 16d 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 · 16d 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 · 16d 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 · 16d agoNeutral↗ source
  • FDA grants rapid approval to Revolution Medicines' pancreatic cancer drug Rasonque
    FDA approved Revolution Medicines' pancreatic cancer therapy Rasonque, just over a month after submission using a priority review voucher. The drug, formerly known as daraxonrasib, is for patients…
    BioPharma Dive · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d agoApprovalPositive↗ source
  • Biohaven sells rights to its lead epilepsy drug opakalim to SK Biopharma for up to $795 million
    Biohaven announced it will transfer the rights to its most advanced experimental therapy for focal epilepsy, known as opakalim, to South Korean company SK Biopharma. The agreement could bring as m…
    BioPharma Dive · 17d agoDealNeutral↗ source