Category Archives: adcom

The FDA Should Provisionally Approve Vascepa

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) rocked the biotech industry last week by voting 9 to 2 against approval of Amarin Pharmaceuticals Inc.’s fish-oil derived omega-3 supplement Vascepa in the supplemental indication of mixed dyslipidemia. The drug…


Oh, Give it Iressa! Nope: ‘Bad Pharma’ Firms Need to Tell More

So urgently did I think I wanted to read Ben Goldacre’s Bad Pharma, that I ordered it from Amazon’s UK site last November, unwilling to wait for U.S. publication – which happened just as I reached the end, polishing off…


Patients Want More than Check-the-Box Experience

Patients getting their four minutes to say how an experimental drug changed their life or gave them hope have become a routine part of nearly every FDA advisory committee meeting – as routine as the call to order or the…