Tag:
Daxas
Latest Headlines
Latest Headlines
NICE asks for more data on Merck/Nycomed COPD drug
The U.K.'s cost-effectiveness watchdog has cast a skeptical eye on Merck ( $MRK ) and Nycomed's new lung drug Daxas. In draft guidance, the National Institute for Health and Clinical Excellence said
Forest, Nycomed win narrow FDA approval on new COPD drug
Forest Labs and Switzerland's Nycomed have managed to overcome some sharp criticism from a panel of experts and win a narrow approval of Daliresp (roflumilast) to prevent the exacerbation of COPD.
Nycomed wins EU approval for COPD therapy
Despite being rebuffed by the FDA and its drug experts, Switzerland's Nycomed has won EU approval for Daxas , its new therapy to treat chronic obstructive pulmonary disorder. The approval will usher
FDA stiff-arms Daxas, demands more info on COPD drug
Forest Laboratories may be second-guessing its decision to provide $100 million upfront to license marketing rights to Nycomed's respiratory drug Daxas. The FDA rejected the COPD drug yesterday,
With Daxas deal, Merck gets into European COPD
Swiss drugmaker Nycomed is bringing Merck ( NYSE: MRK ) on board to help sell its new lung drug Daxas in Canada and in Europe, where it just won a recommendation for approval last week. It's a score
Nycomed scores Merck co-promotion pact for Daxas
Nycomed's COPD drug Daxas may be in deep trouble in the U.S. , but a thumb's up from the European Medicines Agency last week set the stage for a new co-promotion deal with Merck covering the continent
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
FDA panel rejects Forest, Nycomed drug Daxas for COPD
In a 10-5 decision, an FDA expert panel voted against approval Daxas, Forest Laboratories and Nycomed's drug for chronic obstructive pulmonary disorder (COPD). The panel did vote 9-6 that the drug is
FDA staffers question Daxas' safety, benefits and suicides as review looms
Shares of Forest Laboratories slid this morning after investors got a chance to look over some of the FDA staff's skeptical questions for Daxas, a potential new blockbuster for smoker's lung that
Promising results for Nycomed, Forest COPD drug Daxas
New partners Nycomed and Forest Laboratories have finally released the results from four pivotal late-stage studies of Daxas (roflumilast), an experimental treatment for chronic obstructive
