BioCentury
ARTICLE | Regulation

A roll of the dice

May 14, 2007 7:00 AM UTC

Regulation

There may be better days to come for the cancer immunotherapy space, but last Wednesday was not one of them. The Oncologic Drugs Advisory Committee's thumbs-down for IDM Pharma Inc.'s Junovan mifamurtide for osteosarcoma and the approvable letter for Dendreon Corp.'s Provenge sipuleucel-T prostate cancer vaccine underlined that FDA is in no mood to relax its demand for well-designed trials that meet their primary endpoint...