Zolgensma Fall-Out: Is Threat To Novartis – Or US FDA Climate Overall?
FDA’s disclosure of data “manipulation” in the application for the SMA gene therapy Zolgensma prompted two immediate inquiries from the US Senate – with very different focuses and potential outcomes.
You may also be interested in...
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
Democratic senators push data-challenged gene therapy into maw of drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question US FDA's decision to withdraw the proposed rule last year.
Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.