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2:23 PM
Aug 07, 2019
 |  BC Extra  |  Company News

Novartis resolute that it acted in good faith on Zolgensma

Novartis contends that the three-month lag between when it discovered Zolgensma data were manipulated and when it reported the issue to FDA was justified and didn't put patients at risk. However, the pharma is doing additional analyses to ensure there is no connection between the assay results in question and the data reported in clinical trials to support the gene therapy's safety and efficacy.

Novartis AG (NYSE:NVS; SIX:NOVN) was caught flat-footed when CBER Director Peter Marks announced on Aug. 6 that the pharma’s AveXis Inc. unit had manipulated animal data for Zolgensma onasemnogene abeparvovec-xioi (see “FDA: AveXis Manipulated Potency Data for Zolgensma”).

The company set up an investor call Wednesday to respond to the announcement, during which Novartis CEO Vasant Narasimhan said the pharma received FDA’s inspection report and Marks’ announcement at the same time they were released to the public.

The data missteps were first reported by...

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