Novartis subsidiary AveXis could face a civil or criminal penalty after the US FDA said the Swiss firm manipulated preclinical data for spinal muscular atrophy gene therapy Zolgensma . Moreover, he alleged, AveXis – the original developer of Zolgensma that Novartis acquired in April 2018 for $8.7 billion – waited to tell the agency even after the therapy won approval. AveXis was allegedly aware data from in vivo mouse studies had been manipulated on more than a month , but waited until more than a month after AveXis had been approved to notify the the US FDA , according to a memo. The FDA said the overall data supported the treatment remaining on the market.
Novartis subsidiary AveXis could face a civil or criminal penalty after the US FDA said the Swiss firm manipulated preclinical data for spinal muscular atrophy gene therapy Zolgensma . AveXis was allegedly aware data from in vivo mouse studies had been manipulated on more than a month , but waited until more than a month after AveXis had been approved to notify the the US FDA , according to a memo. The FDA said the overall data supported the treatment remaining on the market.