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Novartis under investigation for data manipulation of its gene therapy Zolgensma

by Ryan Cross
August 9, 2019 | APPEARED IN VOLUME 97, ISSUE 32

 

AveXis, the gene-therapy subsidiary of Novartis, is being investigated by the US Food and Drug Administration for manipulating data related to its recently approved gene therapy Zolgensma. AveXis told the FDA about the manipulation on June 28, a month after the $2.1 million drug was approved, even though the firm knew about it before the approval. The data relate to the weights and life spans of mice that AveXis used while refining its production process. Since the manipulation is unrelated to evidence of the therapy’s efficacy, the FDA says Zolgensma should remain on the market, although it warns that Novartis may face legal consequences.

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