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  • 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 · 17d 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 · 16d agoDealPositive↗ source
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  • 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 · 17d 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 · 17d 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 · 17d agoDealPositive↗ source
  • Vitruvias Therapeutics shuts down after recalling potentially superpotent thyroid tablets
    Vitruvias Therapeutics announced it is ceasing operations and has voluntarily recalled a batch of its generic thyroid tablets because the product may be superpotent. The recall covers 3,655 units…
    BioSpace · 16d agoCRLNegative↗ 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 · 16d 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 · 16d 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 · 16d 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 · 17d 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 · 17d agoLayoffsNegative↗ source
  • BMS terminates Cellares partnership after cell therapy platform fails to meet Breyanzi production needs, prompting layoffs
    Bristol Myers Squibb has ended its collaboration with manufacturing specialist Cellares after the Cell Shuttle system could not satisfy the requirements for producing the approved CAR‑T therapy Bre…
    BioSpace · 17d agoDealNegative↗ source
  • Biohaven signs up to $795 million deal with SK Biopharma to license Kv7 platform and epilepsy asset
    Biohaven announced a licensing agreement with South Korean SK Biopharma centered on its Kv7 ion channel platform and lead epilepsy candidate opakalim. The deal could deliver up to $795 million, in…
    BioSpace · 17d agoDealPositive↗ 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 · 17d 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 · 17d 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 · 17d agoPositive readoutPositive↗ source
  • FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy review
    The FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
    BioSpace · 17d agoRegulatoryNeutral↗ 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 · 17d 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 · 17d 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 · 17d agoNegative↗ source
  • CDMO hiring struggles as demand for specialized talent outpaces supply
    Contract development and manufacturing organizations are finding it harder to fill positions, according to a search expert who tracks life-science talent. The surge in outsourcing has created a gap…
    BioSpace · 17d agoNeutral↗ 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 · 17d 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 · 17d agoCRLNegative↗ source
  • UCSF maps over 1,800 protein interactions linked to autism, revealing new drug target opportunities
    UCSF scientists created a molecular map of autism by analyzing 100 risk genes, which uncovered more than 1,800 protein-protein interactions. The study found that about 87% of these connections had…
    Fierce Biotech · 17d agoPositive↗ source
  • Spyre Therapeutics deprioritizes anti-TL1A rheumatoid arthritis candidate after modest Phase 2 results
    Spyre Therapeutics said on Tuesday it will shift resources away from its anti-TL1A antibody that was being developed for rheumatoid arthritis. The decision follows the Phase 2 study, which showed…
    Endpoints · 17d agoNegative readoutNegative↗ source