BioSpace News Archive

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  Manufacturing

  As CGT Struggles To Scale, FDA’s New Designation Could Smooth Post-Approval Pivots

  Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.

  November 25, 2025

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  4 min read

   · 

  Nick Paul Taylor
• 

  Weight loss

  Lilly Redefines the Pharma Mega-Blockbuster

  Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.

  November 25, 2025

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  2 min read

   · 

  Annalee Armstrong
• Press Releases

  Actio Biosciences to Present New Preclinical Data for ABS-1230, a KCNT1 Inhibitor for the Treatment of KCNT1-Related Epilepsy, at the American Epilepsy Society Annual Meeting

  November 25, 2025

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  3 min read
• Press Releases

  LivaNova’s VNS Therapy for Drug-Resistant Epilepsy Procedures Receives Increased Provider Reimbursement from U.S. Centers for Medicare & Medicaid Services

  November 25, 2025

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  4 min read
• Press Releases

  HKeyBio Launches the HKEY-AIDMD 3.0--a Next-Generation Platform to Crack the Toughest Challenge in Autoimmune and Allergy Drug Development: Multi-target Combination Strategy Optimization

  November 25, 2025

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  4 min read
• Press Releases

  Lilly to present data from two positive Phase 3 studies of Jaypirca (pirtobrutinib) in chronic lymphocytic leukemia at the 2025 American Society of Hematology (ASH) Annual Meeting

  November 25, 2025

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  19 min read
• Press Releases

  Enquyst Technologies Demonstrates First-in-Class, Chromatography-free Downstream Processing of a Monoclonal Antibody (mAb) with its Patented Isoelectric Point Purification (IPP) Technology Platform and Announces Receipt of a National Institute for Innovation in Manufacturing Biopharmaceutical (NIIMBL) Led Gates Grand Challenge Program Award

  November 25, 2025

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  2 min read
• Press Releases

  Kelonia Therapeutics Announces Late-Breaking Oral Presentation of First-in-Human Data from in vivo BCMA CAR-T Therapy at the American Society of Hematology (ASH) 2025 Annual Meeting

  November 25, 2025

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  5 min read
• Press Releases

  Press release: Transparency Notification from Shareholders

  November 25, 2025

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  7 min read
• Press Releases

  Inside Information: Faron Intends to Issue Second Tranche of Bonds with an Aggregated Principal Amount of Eur 10 Million Under Its Convertible Bond Arrangement

  November 25, 2025

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  6 min read