Posted by Michael Wonder on 23 Aug 2019
FDA focuses on Novartis delay in reporting drug-test data manipulation
22 August 2019 - Regulators zeroing in on the company’s two-month delay in launching a formal inquiry.
Federal regulators examining test data manipulation for a gene-therapy drug made by Novartis are zeroing in on the company’s two-month delay in launching a formal inquiry, according to documents and interviews.
The drug, Zolgensma, is used to treat a sometimes fatal form of spinal muscular atrophy in children and costs about $2.1 million for a one-time infusion. The Food and Drug Administration said this month that it wasn’t informed about the data manipulation until after it approved use of the drug May 24.
