EU recommends Daxas approval following FDA panel rejection

Nycomed is in luck. The European Medicines Agency today recommended approval of Daxas, the company's once-a-day pill for patients with severe COPD. The approval follows an expert FDA panel's decision earlier this month not to recommend the drug for approval. In a 10-5 vote, panelists determined the side effects of Daxas outweighed the limited improvement in lung function. The ruling was a blow to Nycomed's partner Forest Labs, which has U.S. rights to Daxas. A final FDA decision...