Telling off for Novartis over Zolgensma data manipulation
The US Food and Drug Administration has dropped an investigation into Novartis (NOVN: VX) company AveXis, related to the novel spinal muscular atrophy (SMA) Zolgensma (onasemnogene abeparvovec-xioi).
Following its approval in the USA, AveXis revealed an issue which it was thought could affect the accuracy of animal testing data underpinning the biologics license application (BLA).
After the firm admitted handing in its BLA while knowing that it contained altered data from pre-clinical studies, the regulator said civil and even criminal penalties were on the table.
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