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Stock Market & Financial Investment News

News Breaks
January 6, 2013
18:23 EDTVRTXVertex announces FDA grants the first two 'Breakthrough Therapy Designations'
Vertex announced that the U.S. Food and Drug Administration, FDA, granted the first two Breakthrough Therapy Designations to ivacaftor monotherapy and the combination regimen of VX-809 with ivacaftor for CF. Enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act. FDASIA, Breakthrough Therapy Designation is intended to expedite the development and review of a potential new medicine if it is “intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”1
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 Administration’s 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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