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  • Moonwalk Biosciences raises $70M and pivots to RNAi obesity drug development
    Moonwalk Biosciences, a California biotech founded in 2024, announced a new $70 million venture funding round. The capital will support development of its first obesity drug, which uses RNA interf…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Sandoz announces $300 million biosimilar factory in Slovenia and plans to expand pipeline sevenfold
    Sandoz, the generic and biosimilar division of Novartis, said it will invest $300 million to build a new biosimilar manufacturing facility in Slovenia. The company also announced that its newly cr…
    Endpoints · 1d agoDealPositive↗ source
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  • Bristol Myers reports Phase 2 success for GPRC5D‑directed CAR‑T therapy
    Bristol Myers announced positive Phase 2 results for its GPRC5D‑directed CAR‑T therapy aimed at treating multiple myeloma. The study demonstrated encouraging efficacy signals, adding to the growing…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Inhibrx reports promising mid-stage data for OX40 agonist and plans vaccine combos early next year
    Inhibrx Biosciences announced that its OX40 agonist showed encouraging activity in a mid-stage trial involving immunogenic cancers. The data suggest the agent may also enhance responses when paire…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • BrainChild Bio raises $116 million to fund pivotal pediatric brain tumor CAR-T trial
    BrainChild Bio, a Seattle-based biotech, announced it has secured $116 million in financing to support a pivotal clinical trial of its CAR-T therapy aimed at pediatric brain tumors. The funding ro…
    Endpoints · 1d agoDealPositive↗ source
  • Diabetes cell-therapy firms Sernova and Seraxis announce merger
    Two diabetes-focused cell-therapy companies, Sernova and Seraxis, have agreed to merge after decades of developing treatments for the disease. The combined company aims to pool resources and exper…
    Endpoints · 1d agoDealNeutral↗ source
  • Novartis shares tumble after late-stage failure of Avidity-acquired drug
    Novartis announced that its late-stage trial of a drug it acquired from Avidity did not meet its primary endpoints. The setback follows a recent disappointment in a heart disease study, adding pres…
    Endpoints · 2d agoNegative readoutNegative↗ source
  • FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacks
    The U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
    raps · 2d agoRegulatoryNeutral↗ source
  • Six AI agents run on a deskside system to deliver on-premises clinical decision support
    Healthcare organizations have long struggled to balance the promise of artificial intelligence with the need to keep patient data secure. Cloud‑based large language models can provide powerful clin…
    BioPharma Dive · 1d agoPositive↗ source
  • Moonwalk Biosciences raises $70M to advance siRNA obesity therapy
    Moonwalk Biosciences announced it has secured $70 million in financing to move its obesity program into clinical testing. The funding will support development of a small interfering RNA (siRNA) th…
    Endpoints · 1d agoDealPositive↗ source
  • Beam Therapeutics reports one-year data from early-stage AATD gene therapy trial
    Beam Therapeutics released new results from its early-stage gene-editing program targeting alpha-1 antitrypsin deficiency (AATD), a rare condition that can damage the lungs and liver. The data com…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • Anthropic hires corporate development lead to drive biopharma acquisitions and partnerships
    Anthropic, the San Francisco AI company, posted a job for a corporate development lead focused on biopharma. The role will involve sourcing and executing acquisitions, investments and strategic pa…
    Endpoints · 1d agoDealPositive↗ source
  • EMA publishes guidance on voluntary electronic product information submissions for EU MAAs
    The European Medicines Agency released new guidance detailing how companies should provide electronic product information (ePI) when filing marketing authorization applications under the EU's centr…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA makes CBER and CDER leaders permanent amid pending commissioner confirmation
    The FDA announced that the heads of its two major centers, CBER and CDER, have been given permanent appointments. The move provides stability for the centers that oversee biologics and drugs, resp…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Tech giants and health apps push users to link medical records for personalized services
    In the past six months, a wave of tech giants and digital‑health startups have begun urging users to connect their personal medical records through their mobile applications. These companies argue…
    Endpoints · 1d agoNeutral↗ source
  • Consumer apps are turning to patient health records to expand services
    A few years ago patients had to remember every provider they visited and log into each portal separately to collect their full medical history. Gathering records was a fragmented and time‑consuming…
    Endpoints · 1d agoNeutral↗ source
  • Novartis reports Phase 3 pelacarsen trial fails to improve cardiovascular outcomes
    Novartis said its late-stage Phase 3 trial of the antisense drug pelacarsen did not show a benefit in reducing major cardiovascular events compared with placebo. The result adds to a recent string…
    Endpoints · 2d agoNegative readoutNegative↗ source
  • FDA grants accelerated approval to AstraZeneca's oral SERD for breast cancer despite advisory panel opposition
    FDA granted accelerated approval to AstraZeneca's oral selective estrogen receptor degrader, Camizestrant, for a specific group of breast cancer patients. The approval was issued on Friday even th…
    Endpoints · 2d agoApprovalPositive↗ source
  • Novo Nordisk halts two late-stage ziltivekimab heart trials after futility finding
    Novo Nordisk announced it has stopped work early on two additional late-stage clinical studies of its IL-6 inhibitor ziltivekimab, which was being evaluated for heart disease. The decision followe…
    Endpoints · 3d agoNegative readoutNegative↗ source
  • Claret Capital Partners raises €575 million Fund IV to boost European biotech lending
    Claret Capital Partners, a European investment firm, announced that its fourth fund has closed at €575 million. The firm said a significant share of the capital will be deployed as loans to life-s…
    Endpoints · 3d agoDealNeutral↗ source
  • Novartis and Ionis's pelacarsen fails to cut heart events despite lowering Lp(a) levels
    Novartis and Ionis reported that pelacarsen, an RNA therapy aimed at lowering lipoprotein(a), did not reduce major cardiovascular events in a Phase 3 trial of over 8,000 patients. The study compare…
    BioPharma Dive · 4d agoNegative readoutNegative↗ source
  • Novartis pauses CAR-T trials after three patient deaths
    Novartis announced a pause on its experimental CAR-T therapy after three patients died while receiving the treatment. The company said it will halt ongoing immunology and neuroscience studies relat…
    Endpoints · 5d agoRegulatoryNegative↗ source
  • ADARx Pharmaceuticals, backed by AbbVie, files for IPO with three RNAi drugs in clinical trials
    ADARx Pharmaceuticals, an RNA interference biotech based in San Diego, disclosed its plan to go public in a Friday night SEC filing. The company aims to capitalize on the current momentum in biotec…
    Endpoints · 5d agoDealNeutral↗ source
  • Ionis receives FDA approval for Zanvastro, the first treatment for Alexander disease, as Pfizer partners on new ADC program
    The U.S. Food and Drug Administration approved Zanvastro, marking the first approved medicine for the rare and often fatal neurological disorder Alexander disease. Developed by Ionis Pharmaceutical…
    BioPharma Dive · 5d agoApprovalPositive↗ source
  • AbbVie’s dual-acting myeloma drug etentamig meets main Phase 3 goal, showing longer progression-free survival
    AbbVie announced that its bispecific antibody etentamig achieved the primary endpoint in a Phase 3 trial for patients with multiple myeloma who have progressed after two or more prior therapies. Th…
    BioPharma Dive · 5d agoPositive readoutPositive↗ source