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News Breaks
July 31, 2014
16:42 EDTVRTXVertex receives European approval for KALYDECO in eight gating mutations
Vertex Pharmaceuticals announced that the European Commission has approved KALYDECO for people with cystic fibrosis ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator gene. KALYDECO was first approved in Europe in July 2012 for people with CF ages 6 and older who have the G551D mutation, which is the most common gating mutation. The eight additional gating mutations included in todayís approval are G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D. In Europe, approximately 250 people ages 6 and older have one of these non-G551D gating mutations.
News For VRTX From The Last 14 Days
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October 28, 2014
18:42 EDTVRTXOn The Fly: After Hours Movers
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16:21 EDTVRTXVertex expects FY14 revenues $525M-$535M, consensus $551.82M
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16:18 EDTVRTXVertex reports Q3 adjusted EPS (37c), consensus (62c)
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October 22, 2014
05:37 EDTVRTXVertex approval could add 500 more patients, says Piper Jaffray
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October 21, 2014
16:49 EDTVRTXVertex: FDA Advisory Committee recommends approval of KALYDECO
Vertex Pharmaceuticals announced that the U.S. Food and Drug Administrationís Pulmonary Allergy Drugs Advisory Committee voted 13-2 to recommend approval of KALYDECO in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA.
15:25 EDTVRTXPanel backs approval for Vertex CF drug in R117H mutation, Bloomberg says
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15:18 EDTVRTXPanel votes Vertex CF drug safe, works for R117H mutation, Bloomberg reports
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07:11 EDTVRTXFDA Pulmonary-Allergy Drugs Advisory Committe to hold a meeting
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October 17, 2014
10:27 EDTVRTXVertex FDA panel expected to be positive at Piper Jaffray
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10:26 EDTVRTXFDA panel asked to consider benefit of Vertex drug in younger CF patients
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