G551D
With Positive Trial Data, Vertex to Seek Approval for CF Drug in New Genetically Defined Population
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Based on promising results from a late-stage trial, Vertex Pharmaceuticals is hoping to expand the indication of its cystic fibrosis drug Kalydeco (ivacaftor) in other genetically defined patient populations.
MDx/CDx Focus: EC Approves Kalydeco; Cabozantinib in PGx-Targeted NSCLC; Ponatinib, CDx FDA Filing
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European Commission Approves Vertex's Personalized CF Drug Kalydeco
MDx/CDx Focus: FDA Accepts Pfizer's Bosutinib NDA; Kalydeco Approval; AssureRx Credit Line; and more
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FDA Grants Standard Review for Pfizer's NDA for Bosutinib in Ph-Positive CML
Vertex Planning NDA Filing for CF Drug in Patients with G551D Mutations for Second Half of 2011
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After data from a Phase III trial yielded significant improvements in the lung function of study participants who received the investigational drug VX-770, Vertex said it would work with regulatory agencies in the US and abroad to speed the drug's approval.