REGULATORY
Paper Retraction Won’t Impact Zolgensma Japan Approval, Data Deleted from Label
Japanese approval for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) will remain intact despite the recent retraction of a 2010 paper featuring animal study data on the treatment, with regulators upholding their assessment for efficacy and safety. The Ministry of Health,…
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…





