• FDA allows Novartis gene therapy trials to resume after nearly 2 year pause

    25 days ago - By Gene Therapy

    Posted on: 10 August 2021,
    Novartis on Tuesday said it will begin a new study of its gene therapy Zolgensma in older patients with spinal muscular atrophy following the Food and Drug Administration's clearance of administration via a spinal infusion. The regulator had suspended testing of that dosing in October 2019 due to safety concerns.
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  • Fourth Boy Dies in Trial of Astellas Gene Therapy Candidate

    25 days ago - By Gene Therapy

    Posted on: 19 September 2021,
    Astellas Pharma has acknowledged that a fourth boy has died in the troubled Phase I/II trial through which its Astellas Gene Therapies has been evaluating its adeno-associated virus gene therapy candidate AT132 in patients with X-linked Myotubular Myopathy. Unlike the other three boys who all died last year in the Phase I/II ASPIRO trial , the fourth-whose age has not been disclosed-received the lower dose of 1.3×10e14 vg/kg.
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