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KALYDECO in Cystic Fibrosis receives positive CHMP opinion by EMA
- October 21, 2018
- Posted by: Pharmascroll
No CommentsVertex Pharmaceuticals (Europe) Limited announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis
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Positive results from new triple combinations in Cystic Fibrosis, displayed by Vertex
- October 21, 2018
- Posted by: Pharmascroll
Phase 2 results of VX-659 and VX-445 triple combination regimens concurrently published in The New England Journal of Medicine Vertex Pharmaceuticals at the 32ndNorth American Cystic Fibrosis Conference presented Phase 2 data evaluating clinical safety and efficacy as well as in vitro data of two triple combination regimens (VX-659, tezacaftor and ivacaftor; VX-445, tezacaftor and
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Synspira’s drug receives FDA Orphan Designation for Cystic Fibrosis treatment
- October 16, 2018
- Posted by: Pharmascroll
Synspira,a privately held company developing a new class of inhaled glycopolymer-based therapeutics for the treatment of pulmonary disease, announced that it has been granted Orphan Designation by the United States Food and Drug Administration (FDA) for poly (acetyl, arginyl) glucosamine (PAAG15A), for the treatment of cystic fibrosis. Synspira is developing PAAG15A as SNSP113, a potential
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FDA Approves ORKAMBI in Cystic Fibrosis for Children Ages 2-5 Years
- August 13, 2018
- Posted by: Pharmascroll
Vertex Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved ORKAMBI® (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF in this population. ORKAMBI oral granules
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Boehringer Ingelheim to Develop novel Gene Therapy for Cystic Fibrosis
- August 7, 2018
- Posted by: Pharmascroll
Boehringer Ingelheim steps into the field of gene therapy, a focus area of its Research Beyond Borders initiative, with experienced partners, in an effort to bring to cystic fibrosis patients a long-term treatment aimed at correcting the underlying genetic causes of this devastating disease. Boehringer Ingelheim will collaborate with the UK Cystic Fibrosis Gene Therapy
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Kalydeco (ivacaftor) Data Demonstrates Early and Long-Term Disease-Modifying Potential of Treating the Underlying Cause of Cystic Fibrosis
- June 7, 2018
- Posted by: Pharmascroll
Data from KALYDECO® (ivacaftor) studies show the potential to modify the long-term progression of the disease Interim analysis of the ongoing extension study of tezacaftor/ivacaftor combination (approved in the U.S. as SYMDEKOTM) continues to demonstrate consistent safety and sustained benefits up to 48 weeks Studies of investigational triple combination regimens highlight continued progress toward developing medicines
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Vertex Initiates Phase 3 Studies of VX-445, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis
- April 30, 2018
- Posted by: Pharmascroll
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that it is initiating two Phase 3 studies of VX-445, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF). The first Phase 3 study will evaluate approximately 360 people with CF who have one copy of the F508del mutation and one minimal function mutation and is