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Your search keyword '"Cystic Fibrosis Foundation Therapeutics Inc. -- Product development"' showing total 6 results
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6 results on '"Cystic Fibrosis Foundation Therapeutics Inc. -- Product development"'

1. Vertex Announces Results of Phase 3 Study of Ivacaftor in People with CF who have the R117H Mutation

Subjects
United States. Food and Drug Administration, Vertex Pharmaceuticals Inc. -- Product development, Cystic Fibrosis Foundation Therapeutics Inc. -- Product development, Pharmaceutical industry -- Product development, Business, Business, international, Kalydeco (Medication)
Abstract

-Mean absolute treatment difference in lung function across all patients was 2.1 percentage points (p=0.20) and mean relative treatment difference was 5.0% (p=0.06)(n=69); study did not meet its primary endpoint- [...]

Published
2013

2. Interim Data from Phase 2 Combination Study of VX-809 and KALYDECO[TM] (ivacaftor) Showed Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation

Subjects
Vertex Pharmaceuticals Inc. -- Product development, Cystic Fibrosis Foundation Therapeutics Inc. -- Product development, Medical research, Medicine, Experimental, Cystic fibrosis -- Genetic aspects, Pharmaceutical industry -- Product development, Business, Business, international
Abstract

- Interim analysis showed 46% of patients experienced at least 5% absolute improvement in lung function (FEV 1 ) from baseline; 30% of patients experienced at least 10% absolute improvement [...]

Published
2012

3. New England Journal of Medicine Publishes Data from Phase 3 STRIVE Study of KALYDECOTM (ivacaftor) in People Ages 12 and Older with a Specific Type of Cystic Fibrosis

Subjects
United States. Food and Drug Administration, Vertex Pharmaceuticals Inc. -- Product development, Cystic Fibrosis Foundation Therapeutics Inc. -- Product development, Medical research, Medicine, Experimental, Cystic fibrosis, Pharmaceutical industry -- Product development, Ivacaftor, Business, Business, international
Abstract

- Study shows that treating CF by targeting the underlying cause of the disease leads to significant clinical benefits among people with the G551D mutation - CAMBRIDGE, Mass. -- Vertex [...]

Published
2011

4. Interim Phase 2 Data Showed a Combination of VX-770 and VX-809 Improved Function of the Defective Protein that Causes Cystic Fibrosis in People With the Most Common Form of the Disease

Subjects
Vertex Pharmaceuticals Inc. -- Product development, Cystic Fibrosis Foundation Therapeutics Inc. -- Product development, Cystic fibrosis, Pharmaceutical industry -- Product development, Business, Business, international
Abstract

-13.17 mmol/L reduction in sweat chloride in one arm supports further evaluation of a combination approach to treating the root cause of cystic fibrosis- CAMBRIDGE, Mass. -- Vertex Pharmaceuticals Incorporated [...]

Published
2011

5. New England Journal of Medicine Publishes Phase 2 Study of VX-770 as a New Approach to Treat the Underlying Cause of Cystic Fibrosis

Subjects
Vertex Pharmaceuticals Inc. -- Product development, Cystic Fibrosis Foundation Therapeutics Inc. -- Product development, Medical research, Medicine, Experimental, Cystic fibrosis, Clinical trials, Pharmaceutical industry -- Product development, Business, Business, international
Abstract

-Treatment with VX-770 resulted in improvements in lung function and markers of disease- -There were no discontinuations of treatment due to adverse events- -Late-stage Phase 3 clinical trials for VX-770 [...]

Published
2010

6. Vertex Pharmaceuticals Initiates Clinical Trial to Evaluate Combination Regimens of VX-770 and VX-809 Targeting the Defective Protein Responsible for Cystic Fibrosis

Subjects
Vertex Pharmaceuticals Inc. -- Product development, Cystic Fibrosis Foundation Therapeutics Inc. -- Product development, Cystic fibrosis -- Drug therapy -- Genetic aspects, Clinical trials, Pharmaceutical industry -- Product development, Business, Business, international
Abstract

-Primary endpoints of safety, tolerability and effect on CFTR function as measured by sweat chloride- -Phase 2a proof of mechanism clinical trial to enroll people with the most common mutation [...]

Published
2010

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