There was a lot of action on the regulatory side of new drug discovery today. Here's a list of the top hits:
- Denmark's Lundbeck has filed an NDA for is schizophrenia drug Serdolect. The drug has had a tremendously controversial history and was withdrawn in 1998--two years after its initial approval--on fears that it could trigger heart problems
- The FDA has approved ProStrakan's patch to prevent nausea and vomiting among cancer patients. Sancuso has been in development for the past five years.
- The FDA has approved Talecris Biotherapeutics' Gamunex, an immune globulin product for the treatment of chronic inflammatory demyelinating polyneuropathy, a rare autoimmune disorder.
- On Friday Merck's Gardasil was approved for two new gynecological cancers. Report
- here's the release on Serdolect
- read the ProStranka's release on Sancuso
- check out the Gamunex article
- see FiercePharma's Gardasil report