Memo to the Novartis CEO: When in doubt, give the FDA a heads-up
For someone who has made a point of trying to steer Novartis away from scandal, Vas Narasimhan has committed a puzzling blunder.
by Ed Silverman
Aug 13, 2019
3 minutes
For someone who has made a point of trying to steer Novartis (NVS) away from scandal, Vas Narasimhan has committed a puzzling blunder.
Last week, the Food and Drug Administration took the highly unusual step of publicly upbraiding the company, which he has run for the past 18 months, for failing to disclose that certain data from animal testing for a gene therapy was manipulated. The drug maker apparently became aware in mid-March, but did not notify the agency until the end of June. Unaware of the problem, the FDA approved the drug in May.
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