Roche gets Mircera nod, but no launch

It's a victory, but there won't be any party. Roche got the FDA's blessing for its anemia drug Mircera--an event long anticipated by the Swiss drug maker. Instead of moving Mircera quickly onto store shelves as Roche had hoped, however, the company is reeling from last month's setback in its patent infringement case against Amgen.

Roche may appeal the recent Amgen ruling. Mircera has already been launched in four European countries and in the U.K., and more overseas launches are on their way. But if Amgen succeeds in getting a permanent injunction against Mircera, Roche won't be able to sell the drug in the U.S. until at least 2012. That would be quite a setback. At least Roche won't have to contend with much suspense. The injunction hearing is scheduled for this afternoon.

- see Roche's release
- read this report
- take a look at this Forbes article