Skip to Main Content

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. And 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. The discovery occurred in October 2018, although the FDA team wrote they were “already aware” of the issues with the test and had run an independent analysis of corrected data the company submitted to the agency.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

  • Interesting more on pg 5 – “we toured the vivarium with Taryn Cozibe, (b)(6) and Allan Kaspar.”
    And the last name match to your last sentence is not a coincidence – more to come here, I am sure.

Comments are closed.