BioWorld - Friday, July 31, 2026

Gene therapy

  • Skin through magnifier
    July 30, 2026
    By Karen Carey

    Replimune’s RP-1 for melanoma wins over FDA adcom

    Following two complete response letters in the past year, Replimune Group Inc.’s RP-1 (suvolimogene oderparepvec) for unresectable metastatic cutaneous melanoma refractory to PD-1 therapy cleared a major hurdle when the U.S. FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that the efficacy results from the Ignyte phase II study are evaluable and clinically meaningful.
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  • Gene and cell therapies will propel innovation, says Astellas CCO
    October 04, 2024

    Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in this episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.” Zieler also shared his thoughts on creating sustainable health care in aging societies, the innovation cycle gap between the U.S. and Europe, and how collaboration between business and government is critical in forging ahead in this wide-ranging discussion.

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