Weekly Roundup is late. Sorry about that. It has been terribly busy during this change to Spring. And that change is certainly happening here in DC where the daffodils and crocus are lustily blooming, yards are getting cleaned and the temperatures go from freezing to 70 in no time. Since I'm late this week, I tried to make this a particularly good weekly roundup.
- More on Taking the F out of FDA – The Associated Press reports that a number of drug company executives are of the opinion that removing food from the FDA's landscape of responsbilities is a good idea and not only favor it, but are taking in active role in the goal's pursuit.
- Move Over Warfarin, There's a New Drug Coming to Town - Ortho-McNeil announced today that theFDA’s Cardiovascular and Renal Drugs Advisory Committee has determined that rivaroxaban, a novel, investigational, oral anticoagulant, has a favorable risk-benefit profile for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip replacement or knee replacement surgery. he advisory committee agreed by a 15-2 vote that the available clinical data demonstrate a favorable risk-benefit profile. J&JPRD submitted the NDA for rivaroxaban on July 28, 2008. If approved by the FDA, Ortho-McNeil will commercialize rivaroxaban in the U.S. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts.
- FDA Backs Multaq for Approval – Approval, like Spring, appears to be in the air. After a non-approval in 2006, an FDA Advisory Committee recommended a proposed heart drug from Sanofi Aventis be approved by a 10-3 vote for the treatment of patients with non-permanent atrial fibrillation.
- OSI Submits sNDA for Tarceva – OSI Pharmaceuticals announced this week that it was submitting sNDA to gain approval for Tarceva as a first-line maintenance therapy for patients with non-small cell lung cancer. Roche, collaborating with OSI filed for the same outcome in Europe.
That's it for me today. I hope that all enjoyed a good weekend.
