Timeline of a debacle: Novartis missteps hold lessons for diligence, new modalities

How the Zolgensma debacle unfolded and signs Novartis might have missed

Aside from all the questions about who knew what when, and how they should have acted, the Zolgensma data fiasco reveals that Novartis’ due diligence team missed some warning signs. The case has the hallmarks of a cautionary tale for deals of new modalities, where bringing the right skill sets to the room and giving them long enough to sort out the issues should trump fear of missing out.

Novartis AG was rocked on Aug. 6 when FDA’s CBER Director Peter Marks issued a statement accusing the company of data manipulation related to SMA gene therapy Zolgensma onasemnogene abeparvovec-xioi. During a July 24-Aug. 2 inspection of Novartis’ San Diego manufacturing facility, FDA found multiple instances of data manipulation surrounding an in vivo mouse assay used to assess the potency of the early production lots for Zolgensma. The gene therapy will stay on the market as FDA deemed that the safety and efficacy of Zolgensma are not in question.

FDA released the inspection report, form 483, which detailed the findings and revealed that Novartis management had known about the data fudging as early as March, four months before FDA informed the public and two months before Zolgensma

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