Case closed: No penalties for Novartis as FDA ends review of Zolgensma scandal

Novartis appears to have convinced FDA that it cleaned house following last summer’s data manipulation debacle.

Uncovered during a July 24-Aug. 2 inspection of a San Diego manufacturing facility, FDA found multiple instances of data manipulation surrounding an in vivo mouse assay used by the pharma’s AveXis Inc. unit to assess the potency of the early production lots for SMA gene therapy Zolgensma onasemnogene abeparvovec-xioi (see “Timeline of a Debacle”)...