Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Appeared To Believe Novartis Data Manipulation Issues Had Been Rectified Months Before Public Controversy
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)
