Novartis CEO promises to speed data integrity disclosures

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Novartis Chief Executive Vas Narasimhan promised to inform U.S. regulators quickly if credible questions emerge internally over data integrity, he ...

ZURICH: Novartis Chief Executive Vas Narasimhan, facing an uproar over data manipulation involving US$2.1 million gene therapy Zolgensma, pledged on Monday to tell regulators quickly if credible questions emerge in future over data integrity.

Novartis could face possible civil or criminal penalties, the FDA has said. Zolgensma treats spinal muscular atrophy, the leading genetic cause of death in infants. Novartis said it gave"detailed explanations" on Aug. 23 to the FDA about the company's investigation into the data manipulation, and addressed regulators' questions over why the company waited until late June to make disclosures.The company has said it has"exited" scientists it identified in its data manipulation probe. One of those scientists, Brian Kaspar, through his lawyer, has denied wrongdoing.

 

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