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  • 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 · 19d agoApprovalPositive↗ source
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  • FDA approves Rasonque, first therapy targeting genetic cause of advanced pancreatic cancer
    The U.S. Food and Drug Administration has granted approval to Rasonque, a drug from Revolution Medicines, for patients with advanced pancreatic cancer. The medicine, whose generic name is daraxonra…
    STAT · 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
  • Experimental drugs to lower Lp(a) move toward market, promising billions in potential sales
    High levels of lipoprotein(a), or Lp(a), are a genetic risk factor for heart disease that affects roughly one in five people and currently has no approved therapy. Several drugmakers are moving ex…
    STAT · 19d agoPositive↗ 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
  • Spyre Therapeutics cuts rheumatoid arthritis program after weak Phase 2 TL1A antibody results
    Spyre Therapeutics reported that its Phase 2 study of the anti‑TL1A antibody SPY072 in rheumatoid arthritis did not meet the efficacy expectations set earlier this year. The company said the data f…
    Fierce Biotech · 19d agoNegative readoutNegative↗ source
  • SK Biopharma signs $795 million licensing deal with Biohaven for epilepsy therapy opakalim
    SK Biopharma has entered a licensing agreement with Biohaven Pharmaceuticals to acquire worldwide rights to the Kv7 ion channel activator opakalim (BHV-7000) for epilepsy. The deal provides an upf…
    Fierce Biotech · 19d agoDealPositive↗ source
  • MassBio CEO warns 2025 may be biotech's toughest year amid China and NIH challenges
    Massachusetts is widely regarded as the epicenter of biotech because of its world‑class research institutions and vibrant startup ecosystem. MassBio CEO Kendalle Burlin O’Connell said 2025 will pr…
    Endpoints · 18d agoNegative↗ source
  • Flagship’s ProFound Therapeutics secures up to $35 M from Gates Foundation to discover preeclampsia drug targets
    Flagship Pioneering’s ProFound Therapeutics has entered a new partnership with the Gates Foundation that could provide up to $35 million for research. The agreement includes an initial $20 million…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Early Inclusion of China Boosts Global Biotech Clinical Development Efficiency
    Many global biotech firms still treat China as a later-stage commercial market, adding it only after key development decisions. This practice often forces costly bridging studies, extends timelines…
    Fierce Biotech · 18d agoPositive↗ source
  • Haisco licenses inflammatory disease candidate to US startup Sentivera; ViiV's HIV drug cleared for newborns
    Haisco Pharmaceutical announced that it has granted a license to US biotech Sentivera for the ex‑China rights to an unnamed inflammatory‑disease candidate. The agreement gives Sentivera the ability…
    Endpoints · 18d agoDealNeutral↗ source
  • Aurora Therapeutics halts lead CRISPR program and cuts staff
    Aurora Therapeutics, founded as the first company dedicated to developing custom CRISPR-based gene-editing medicines, announced a major restructuring. The firm said it is laying off several employ…
    Endpoints · 18d agoLayoffsNegative↗ source
  • U.S. Employers Plan to Drop GLP-1 Drug Coverage, Survey Shows 14% Will Cut Benefits by 2027
    About 14% of U.S. employers have already decided or intend to stop covering GLP-1 medicines by 2027, according to a Reuters‑cited Business Group on Health survey. The shift reflects growing concern…
    STAT · 18d agoNegative↗ source
  • Akeso and Summit report ivonescimab meets primary endpoint in China Phase 3 biliary tract cancer trial
    Akeso Therapeutics and partner Summit Therapeutics announced that their bispecific antibody ivonescimab achieved the primary efficacy endpoint in a Phase 3 study conducted exclusively in China. Th…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Faro AI secures $37M Series B to accelerate clinical trials with artificial intelligence
    Faro AI, a San Diego‑based startup, announced a $37 million Series B financing round aimed at expanding its artificial‑intelligence platform. The new funding will be directed toward developing too…
    Endpoints · 19d agoDealPositive↗ source
  • Akeso reports phase 3 overall survival win for ivonescimab in advanced biliary tract cancer
    Akeso announced that its bispecific antibody ivonescimab combined with chemotherapy improved overall survival in a China phase 3 trial for advanced biliary tract cancer, beating the standard regime…
    Fierce Biotech · 19d agoPositive readoutPositive↗ source
  • Deloitte urges advanced therapy makers to adopt AI-driven digital staff to overcome operational bandwidth limits
    Advanced therapy manufacturers are confronting an operational bottleneck as their pipelines expand rapidly. More than a thousand advanced therapies are in development and the U.S. patient pool is e…
    Fierce Biotech · 19d agoNeutral↗ source
  • Profit motive highlighted as key to advancing women’s health research and boosting economic productivity
    Experts say that turning to the profit motive could spur investment in under‑funded women’s health areas such as endometriosis, osteoporosis and autoimmune disorders. They note a long history of r…
    STAT · 19d agoNeutral↗ source
  • FDA clears Abbott’s Libre Duo 10-Day sensor to warn of diabetic ketoacidosis
    The U.S. Food and Drug Administration has cleared Abbott’s new wearable device that measures both glucose and ketone levels in people with diabetes. The clearance allows the product to be marketed…
    Fierce Biotech · 19d agoApprovalPositive↗ source
  • Boston Scientific reports cyberattack that disrupts operations and order processing
    Boston Scientific disclosed in an SEC filing on Aug. 26 that it detected a cybersecurity incident the previous day, marking the latest medtech cyberattack of the year. The breach impacted several…
    Fierce Biotech · 19d agoNegative↗ source
  • Baxter recalls two lots of 0.9% Sodium Chloride Injection over possible fiberglass particles
    Baxter International announced a voluntary recall of two batches of its 0.9% Sodium Chloride Injection after detecting potential fiberglass particles in the solution. The company said the particul…
    fda medwatch · 19d agoCRLNegative↗ source
  • Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System after sheath tip separation reports
    Boston Scientific announced a recall of its ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus. The FDA classified the recall as the most serious…
    fda medwatch · 19d agoCRLNegative↗ source
  • Baxter voluntarily recalls one lot of anticoagulant sodium citrate solution over possible fiberglass particles
    Baxter International announced a voluntary recall of a single lot of its Anticoagulant Sodium Citrate Solution, USP, 250 mL, packaged in a VIAFLEX plastic container. The recall was triggered after…
    fda recalls · 19d agoCRLNegative↗ source