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Novartis’s Zolgensma In Spotlight As Second Death Is Probed

 
• By Kevin Grogan

Reports of patient deaths could raise questions around safety for Novartis's gene therapy Zolgensma which is expected to get the green light imminently from the FDA.

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Not much time left before FDA Zolgensma decision • Source: Shutterstock

As the action date approaches that could see Zolgensma approved in the US as the first gene therapy for spinal muscular atrophy, Novartis AG has reported two deaths in its clinical trial program that highlight the challenges in developing potentially game-changing therapies.

Last week (16 April), the Swiss major reported interim data from the Phase III STR1VE study of Zolgensma (onasemnogene abeparvovec,...

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