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#细胞治疗

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Sep 30Wed
  1. biospace.com45

    Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again

    Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have resubmitted the BLA for Ebvallo (tabelecleucel) to treat EBV-positive posttransplant lymphoproliferative disease in patients 2 years and older, after two complete response letters, the second in January. The FDA reversed course in May, agreeing a single-arm study with an appropriate historical control could support approval. The resubmission adds patients and longer follow-up from the Phase 3 ALLELE trial plus expanded access, separate study and European commercial data; a Class 2 resubmission could carry a March 29, 2027 action date, and Atara is eligible for a $31 million milestone on approval.

Sep 1Tue
  1. aacrjournals.org61

    First CAR T-Cell Therapy Approved for Solid Tumors

    China has approved satricabtagene autoleucel (satri-cel), the first CAR T-cell therapy for solid tumors, for patients with claudin 18.2-positive, HER2-negative gastric or gastro-esophageal junction cancer. The approval is based on a phase II trial showing improved progression-free and overall survival. Scientists welcome the decision but say more research is needed to improve CAR T-cell effectiveness against solid tumors.

    Why it matters: First regulatory approval of a CAR T-cell therapy for a solid tumor indication.

Aug 25Tue
Aug 15Sat
  1. BioCentury50

    Will Capricor’s latest move give deramiocel new life?

    Capricor Therapeutics will amend its BLA for deramiocel to seek approval to improve limb function in Duchenne muscular dystrophy patients, shifting from the prior indication in DMD cardiomyopathy. The company hopes the change will refocus FDA on the primary endpoint of the Phase III HOPE-3 trial, after the application was derailed by an advisory committee vote centred on a secondary endpoint. Capricor shares rose 58% to $6.65 on Friday, giving a market cap near $400 million.

Aug 14Fri
CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org