In a statement, Novartis (NVS -1.5%) unit AveXis announces that Global Head of Preclinical Safety for Novartis Institutes for BioMedical Research Page Bouchard, DVM was appointed SVP of Research and Chief Scientific Officer (CSO) effective August 5. The 10-year Novartis veteran will take over the roles of former CSO Brian Kaspar, Ph.D. and SVP R&D Allan Kaspar, Ph.D.
AveXis says the Kaspar brothers “have not been involved” in any operations since early May and are “no longer with the company.”
Both former executives oversaw the data and analyses that supported the marketing application for gene therapy Zolgensma (onasemnogene abeparvovec-xioi), approved in the U.S. in May for spinal muscular atrophy.
Last week, the FDA reported a “data manipulation issue” impacting certain animal tests that AveXis was aware of before approval but did not notify the agency until late June.
In a statement released last week, Novartis said it is “fully confident” in the safety, quality and efficacy of the product.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.