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Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

 
• By Derrick Gingery

Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

FDA entrance sign 2016
US FDA said it was told of the manipulated data after Zolgensma's approval, but that AveXis knew before clearance. • Source: Shutterstock

Novartis AG and subsidiary AveXis Inc. may face civil or criminal action after revelations by the US Food and Drug Administration that not only was data used for approval of the gene therapy Zolgensma manipulated, but also that the company knew about the problem before the product was approved and did not disclose it.

Center for Biologics Evaluation and Research Director Peter Marks said in a 6 August statement that the FDA is assessing the situation, but "remains confident that Zolgensma should remain on...

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