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News Breaks
June 27, 2014
07:17 EDTVRTXVertex receives European CHMP 'positive opinion' for KALYDECO
Vertex announced that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending the approval of 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. The CHMP opinion is based on previously announced data from the first part of a Phase 3, two-part, randomized, double-blind, placebo-controlled, cross-over study of 39 people with CF ages 6 and older who have a non-G551D gating mutation. The first part of the study showed statistically significant improvements in lung function, sweat chloride, BMI and CFQ-R scores. Data from the second part of the study were presented at the European Cystic Fibrosis Society Conference and showed that these improvements were maintained through 24 weeks of treatment with ivacaftor. The safety profile was similar to prior Phase 3 studies of ivacaftor in people with the G551D mutation. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the E.U. The European Commission generally follows the recommendation of the CHMP and typically issues marketing approval within three to four months. The CHMP also issued a positive opinion recommending the inclusion of data from the long-term follow-up PERSIST study in the KALYDECO label
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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