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Bronchitol AdComm Shows Difficulty Of Following In Kalydeco’s Shadow

Executive Summary

Comparisons between the robustness of the efficacy data for dry powder mannitol and Vertex’s ivacaftor were difficult for FDA to avoid during the Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 review of Pharmaxis’ cystic fibrosis drug.


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Secondary Endpoints Backed Kalydeco’s Efficacy, Despite Lack Of Correlation With Pulmonary Function
FDA Liked What It Saw In Kalydeco’s Development Program


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