Cystic Fibrosis

Vertex to submit CF drug combo to FDA this year

Vertex to submit CF drug combo to FDA this year


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.

Business briefs: AbbVie, FDA, and health spending projections

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

In wake of HCV setback, Vertex to contain marketing spend


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.

Business Briefs: GSK, Astellas, Vertex and Orexigen

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.

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