'Slam dunk' for Astellas antifungal Cresemba at FDA panel
This article was originally published in PharmAsia News
Astellas had few battles to wage on 22 January when it took its experimental antifungal Cresemba (isavuconazonium) before the U.S. FDA's Anti-Infective Drugs Advisory Committee (AIDAC), which wholeheartedly embraced the medicine as a treatment for the deadly invasive infection aspergillosis, and nearly so for use in another fungal infection, mucormycosis.
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.