Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says
Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.
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Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.
Novartis has completed its absorption of AveXis and rebranded the acquired gene therapy specialist that developed the soon-to-be SMA blockbuster Zolgensma despite struggling to meet the data integrity standards of regulators and big pharma.
Company’s promise to be more forthright, along with quality culture and policy upgrades, may have helped sway agency.