Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.
AbbVie and Galapagos go after cystic fibrosis; FDA's NME approval pace slows; government shutdown could slow ad-com votes; and a report shows privately insured patients had emptier pockets in 2012 than 2011
While a strong launch of CF drug Kalydeco helped to hike the biotech's forecast, hep. C contender VTX-135 was hit with a partial clinical hold.
GSK and Astellas kick off the race for a new anemia treatment; Orexigen's CEO joins PhRMA; BMS and Merck team up in a hep.-C clinical trial; Novartis lands glaucoma approval; Ireland starts naming preferred drugs; Novo has new New Jersey digs; Vertex releases promising data for new cystic fibrosis treatment.