FDA Appeared To Believe Novartis Data Manipulation Issues Had Been Rectified Months Before Public Controversy
An FDA said Novartis scientists were “already aware” of the issues with the test and had run an independent analysis of corrected data the company submitted to the agency. In other pharmaceutical news, Britsol-Myers moves closer to completing its acquisition of Celgene.
Stat:
An FDA Report Reveals The Agency Believed Novartis Data Problems Were Resolved Months Ago
Shortly before serious data problems surfaced in mid-March at a troubled Novartis (NVS) unit, a Food and Drug Administration report noted the company had recently conducted an “extensive investigation” after finding errors and discrepancies in a preclinical test. The agency apparently believed the difficulties had been rectified. In a February 2019 report, FDA personnel noted that AveXis — the Novartis unit at the center of a scandal over manipulating data for the gene therapy — uncovered problems with a so-called mouse assay. (Silverman, 8/27)
The Wall Street Journal:
Bristol-Myers Moves Closer To Buying Celgene
Bristol-Myers Squibb Co. took a major step toward completing its $74 billion acquisition of Celgene Corp., as the two pharmaceutical companies found a buyer for a skin treatment whose sale they hope will address antitrust concerns. Amgen Inc. agreed on Monday to buy Celgene’s psoriasis medicine Otezla for $13.4 billion in cash. The decision comes after the U.S. Federal Trade Commission raised anticompetitive concerns related to anti-inflammatory drugs, of which Otezla is an example. (Hopkins and Kellaher, 8/26)
