US FDA's Rush Following Novartis' Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation
Early release of inspection findings is unusual, signaling likelihood that Novartis will face tough scrutiny of its actions, and perhaps stiff fines because of the fraud.
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The big pharma could not confirm whether AveXis co-founder and CSO Brian Kaspar and his brother, SVP of R&D Allan Kaspar, were fired. Instead, Novartis noted that the withholding of preclinical safety data for Zolgensma was limited to the action of a few employees. NIBR preclinical safety chief takes key role at AveXis
Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First
Novartis is in the process of "exiting" the "small number" of scientists involved in the fraud, CEO Narasimhan says.
Heritage agrees to pay $7.1m to resolve civil allegations and a $225,000 criminal penalty. DOJ defers prosecution of one felony charge.