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Date Title and Summary Additional Formats
Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO™ (ivacaftor) in Eight Non-G551D Gating Mutations
-In Europe, approximately 250 people ages 6 and older have one of 8 additional gating mutations- -KALYDECO is the first medicine to treat the underlying cause of CF in people with non-G551D gating mutations- EYSINS, Switzerland --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
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Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis
- Global studies showed significant and sustained improvements in lung function and other measures of disease among people with a specific genetic mutation - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Committee for
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Toggle Summary Vertex Receives European CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
- If approved, lumacaftor/ivacaftor will be the first medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 young children with two copies of the F508del mutation - LONDON --(BUSINESS WIRE)--Nov. 16, 2018-- Vertex Pharmaceuticals (Europe) Limited today
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Toggle Summary Vertex Receives European CHMP Positive Opinion for SYMKEVI® (tezacaftor/ivacaftor) for People with Cystic Fibrosis Aged 12 and Older with Certain Mutations in the CFTR Gene
If approved, SYMKEVI ® (tezacaftor/ivacaftor) will be Vertex’s third medicine to treat the CFTR protein defect in patients with cystic fibrosis – a rare life-shortening disease LONDON --(BUSINESS WIRE)--Jul. 27, 2018-- Vertex Pharmaceuticals (Europe) Limited , today announced that the European
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Toggle Summary Vertex Receives Two EU Approvals for KALYDECO® (ivacaftor) for People with Cystic Fibrosis
- European Commission approves expanded use of ivacaftor in children with cystic fibrosis ages 2 to 5 who have one of 9 gating mutations; approximately 125 children ages 2 to 5 have one of the approved gating mutations in Europe - - European Commission approves expanded use of ivacaftor in people
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Toggle Summary Vertex Receives U.S. Food and Drug Administration Approval of KALYDECO® (ivacaftor) for Children with Cystic Fibrosis Ages 2 to 5 who have Specific Mutations in the CFTR Gene
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved KALYDECO ® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance
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Toggle Summary Vertex Recommends Rejection of ‘Mini-Tender’ Offer From TRC Capital Investment Corporation
BOSTON --(BUSINESS WIRE)--Nov. 13, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that it has been notified of an unsolicited “mini-tender” offer dated November 9, 2020 , made by TRC Capital Investment Corporation , an Ontario, Canada , corporation to purchase up to
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Toggle Summary Vertex Reports 2010 Financial Results and Highlights Recent Progress in Hepatitis C and Cystic Fibrosis Development Programs
  -Hepatitis C: Regulatory agencies in U.S., Europe and Canada to provide accelerated reviews of telaprevir applications- -Cystic Fibrosis: First Phase 3 registration data for VX-770 expected in first quarter 2011; potential regulatory submissions in the U.S. and E.U.
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Toggle Summary Vertex Reports 52% SVR 12 Rate for a 24-week Telaprevir-based Regimen in Genotype 1 Hepatitis C Patients Who Failed Prior Treatment
-- 73% of prior relapsers achieved SVR12 with 24-week<br> telaprevir-based treatment<br><br> -- 41% of prior non-responders achieved SVR12 with 24-week<br> telaprevir-based regimen
HCV
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Toggle Summary Vertex Reports First Quarter 2011 Financial Results and Reviews Milestones for Key Development Programs
-Hepatitis C: FDA decision on NDA for INCIVEK TM (telaprevir) expected this month- -Cystic Fibrosis: Phase 3 program for VX-770 supports applications for approval in U.S. and E.U., with NDA and MAA planned for second half of 2011- -Financial: Vertex enters second quarter with more than $820 million
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