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Toggle Summary CRISPR Therapeutics and Vertex Announce FDA Has Lifted the Clinical Hold on the Investigational New Drug Application for CTX001 for the Treatment of Sickle Cell Disease
ZUG, Switzerland   and   BOSTON   and   CAMBRIDGE, Mass. ,   Oct. 10, 2018   (GLOBE NEWSWIRE) --   CRISPR Therapeutics  (NASDAQ:CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and   Vertex Pharmaceuticals Incorporated   (NASDAQ:VRTX)
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Toggle Summary Vertex to Announce Third Quarter 2018 Financial Results on October 24
BOSTON --(BUSINESS WIRE)--Oct. 16, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its third quarter 2018 financial results on Wednesday, October 24, 2018 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
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Toggle Summary Vertex Data Presented at North American Cystic Fibrosis Conference (NACFC) Demonstrate Rapid Progress Toward Expanding and Enhancing Options for Treating the Underlying Cause of Cystic Fibrosis
- Phase 2 results of VX-659 and VX-445 triple combination regimens concurrently published in The New England Journal of Medicine - - Phase 3 ARRIVAL data support treating the underlying cause of cystic fibrosis with KALYDECO ® (ivacaftor) as early as six months of age - - Patient-reported outcomes
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Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Patients With Cystic Fibrosis Aged 12 to <24 months With Certain Mutations in the CFTR Gene
If approved, ivacaftor will be the first and only medicine to treat the underlying cause of cystic fibrosis for these young children LONDON --(BUSINESS WIRE)--Oct. 19, 2018-- Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal
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Toggle Summary Vertex Reports Third-Quarter 2018 Financial Results
-Third-quarter 2018 total CF product revenues of $783 million , a 42% increase compared to $550 million in the third quarter of 2017- -Company reiterates full-year 2018 total CF product revenue guidance of $2.9 to $3.0 billion ; reiterates full-year 2018 combined non-GAAP R&amp;D and SG&amp;A expense
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Toggle Summary Vertex Announces European Authorization for Third Cystic Fibrosis Medicine SYMKEVI® (tezacaftor/ivacaftor), to be used in combination with ivacaftor (KALYDECO®), for People with CF Aged 12 and Older with Certain Mutations in the CFTR gene
- A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis - - First medicine in the EU to treat the CFTR protein defect in patients who have one copy of the F508del mutation and one copy of one of 14 mutations that result in residual
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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 Two Phase 3 Studies of the Triple Combination of VX-659, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis
-Mean absolute improvement in ppFEV 1 of 14.0 percentage points from baseline at week 4 in people with one F508del mutation and one minimal function mutation compared to placebo (p
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) to Treat Patients with Cystic Fibrosis Aged 12 to <24 months with Certain Mutations in the CFTR Gene
Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in these young patients LONDON --(BUSINESS WIRE)--Nov. 29, 2018-- Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label
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Toggle Summary Health Canada Grants Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) for Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
- ORKAMBI is the first medicine in Canada to treat the underlying cause of CF in young children with two copies of the F508del mutation - BOSTON --(BUSINESS WIRE)--Dec. 13, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that Health Canada has granted Market Authorization
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