FDA Week - 08/09/2019

FDA: Makers Of Zolgensma Withheld Info On Manipulated Data

By David Roza
August 6, 2019 at 4:46 PM
FDA on Tuesday (Aug. 6) announced that it was investigating a report from drug-maker AveXis Inc. in late June of data manipulation regarding the manufacturing process of the recently approved gene replacement therapy Zolgensma. Though FDA will allow Zolgensma to stay on the market as it investigates the matter, FDA Acting Commissioner Ned Sharpless and biologics center director Peter Marks said AveXis, a Novartis company, could face civil or criminal penalties for not telling FDA about the manipulation issues before...

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