US government wins ok to join Rapamune whistleblower suit against Pfizer
This article was originally published in Scrip
The federal government has won a US judge's approval to intervene in a whistleblower suit accusing Pfizer's Wyeth unit of illegally marketing the kidney-transplant drug Rapamune (sirolimus) for use in other, unapproved organ transplant operations, and for offering kickbacks to providers.
You may also be interested in...
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.
Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.