Pharma's Cutting Edge

FDA finally admits need for large safety studies premarketing

For the last few years, I have held an opinion contrary to most of my colleagues in the industry--that sponsors should be required to conduct large (simple) safety studies prior to marketing authorization for drugs intended to be used chronically in large, especially elderly, populations. Such studies would have as their primary ...

CB1 antagonist update, and a poor excuse

I recently reported on Sanofi-Aventis' decision to pull rimonabant from EU shelves. Since then, S-A has stopped all rimonabant clinical development. I also told you that clinical success of Pfizer's Phase 3 CB1 antagonist, CP-945,598, seemed dubious. Yesterday, Pfizer pulled the plug on their drug, citing "changing regulatory perspectives on the risk/benefit ...

Off-base on off-label promotion

You might have caught the editorial published today on PLoS Medicine by Fugh-Berman and Melnick, which decries rampant, greed-driven off-label promotion by pharmaceutical marketers. They suggest that the US government step in with tighter reigns and resist "gutting" current restrictions against off-label promotion. The authors make their argument without providing evidence ...