Novartis AG will not face any penalties for data integrity lapses in certain potency studies for its AveXis Inc. unit’s Zolgensma (onasemnogene abeparvovec-xioi) gene therapy that the US Food and Drug Administration investigated last year, the agency has decided.
US FDA Decides Against Zolgensma Data Integrity Penalties As Novartis Bureaucratizes AveXis
Company’s promise to be more forthright, along with quality culture and policy upgrades, may have helped sway agency.
