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www.fdanews.com/articles/152466-vertex-cf-drugs-nab-first-two-breakthrough-therapy-designations

Vertex: CF Drugs Nab First Two Breakthrough Therapy Designations

January 17, 2013
Vertex’s cystic fibrosis (CF) drug Kalydeco and the combination regimen of VX-809 with Kalydeco have received the FDA’s first two breakthrough therapy designations, the company said Jan. 6. The implications of the designation are as yet undetermined, Vertex said.
Washington Drug Letter