Novartis Chief Executive Vas Narasimhan, facing an uproar over data manipulation involving $2.1 million gene therapy Zolgensma, pledged on Monday to tell regulators quickly if credible questions emerge in future over data integrity.
Novartis has said it knew of discrepancies in Zolgensma data it had submitted to the U.S. Food and Drug Administration before it won approval for the world's most expensive medicine in May, but delayed informing regulators until June 28 while it completed an internal investigation.
Novartis has said it knew of discrepancies in Zolgensma data it had submitted to the U.S. Food and Drug Administration before it won approval for the world's most expensive medicine in May, but delayed informing regulators until June 28 while it completed an internal investigation. "We are making a voluntary commitment to notify the FDA within five business days of receipt by our quality organisation of any credible allegation related to data integrity impacting any pending application in the Novartis Group," Narasimhan said at an investor event, adding Novartis will take a similar approach in other jurisdictions.
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