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Toggle Summary Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years
- The combination therapy is a new treatment option for CF patients who are homozygous for F508del - - The only medicine to treat the underlying cause of CF in this age group with one F508del mutation and one of 14 residual function mutations - LONDON --(BUSINESS WIRE)--Nov.
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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 Announces European Commission Approval for KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With Cystic Fibrosis as Early as Four Months of Age
- Approval provides opportunity to treat the underlying cause of cystic fibrosis earlier than ever before in Europe - LONDON --(BUSINESS WIRE)--Nov. 5, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension
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Toggle Summary CRISPR/Cas9 Gene-Editing Therapy CTX001™ for Severe Hemoglobinopathies Accepted for Plenary Presentation at the 62nd American Society of Hematology (ASH) Meeting and Exposition
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Nov. 04, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data in seven patients from two ongoing Phase 1/2 clinical trials of the investigational CRISPR/Cas9
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Toggle Summary Vertex Provides Update on its Clinical Programs Targeting Alpha-1 Antitrypsin Deficiency
- Phase 2 study of VX-814 in patients with alpha-1 antitrypsin deficiency discontinued based upon safety and pharmacokinetic data - - Phase 2 study of VX-864 continues to enroll and dose patients; data expected in H1 2021 - - AATD research program continues to progress - BOSTON --(BUSINESS
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Toggle Summary FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age
-Approval provides opportunity to treat the underlying cause of CF earlier than ever before- -Safety data from a cohort of the Phase 3 ARRIVAL study support treatment with KALYDECO in children ages four to
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Toggle Summary Vertex to Present New Data at European and North American Virtual Cystic Fibrosis Conferences Highlighting Long-Term Use of CFTR Modulators
- Oral presentation of interim results from TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) open-label safety extension study to be presented at the ECFS Digital Conference - - Six presentations highlighting data from KALYDECO ® (ivacaftor), ORKAMBI ® (lumacaftor/ivacaftor) and TRIKAFTA
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Toggle Summary CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001™ for the Treatment of Sickle Cell Disease
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Sept. 22, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Inco r porated  (Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001, an
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Toggle Summary Moderna and Vertex Establish New Collaboration to Treat Cystic Fibrosis Using Gene Editing
Second collaboration between Moderna and Vertex based on Moderna’s proprietary mRNA and LNP technology Collaboration will leverage Vertex’s investments and capabilities in genetic technologies for CF Moderna to receive $75 million upfront, with potential for additional development, regulatory and
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Toggle Summary Vertex Announces European Medicines Agency Type II Variation Marketing Authorization Application Validation for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination with ivacaftor in People with One Copy of the F508del Mutation
LONDON --(BUSINESS WIRE)--Sep. 14, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has validated a Type II Variation Marketing Authorization Application (MAA) for the expanded indication of KAFTRIO ®* (ivacaftor/tezacaftor/elexacaftor)
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Toggle Summary Vertex Announces Positive Phase 3 Study for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children Ages 6-11 Years With Cystic Fibrosis to Support Submissions for Global Regulatory Approvals
BOSTON --(BUSINESS WIRE)--Sep. 10, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the company has completed a global Phase 3 study of TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)   in children ages 6 through 11 years old with cystic fibrosis (CF) who have
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Toggle Summary FDA Accepts Vertex’s Supplemental New Drug Applications for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Additional CFTR Mutations
- More than 600 people with certain rare CF mutations could become newly eligible for TRIKAFTA, SYMDEKO or KALYDECO - BOSTON --(BUSINESS WIRE)--Sep. 1, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted three supplemental
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Toggle Summary European Commission Approves KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat Cystic Fibrosis in People Ages 12 Years and Older
– For the first time, up to 10,000 people in Europe ages 12 years and older with one F508del mutation and one minimal function mutation will be eligible for a medicine that treats the underlying cause of cystic fibrosis – – People 12 years of age and older who have two F508del mutations will also
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Toggle Summary Positive Phase 3 Study Results for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in People Ages 12 and Older With Cystic Fibrosis Who Have One Copy of the F508del Mutation and One Gating or Residual Function Mutation
-Phase 3 study met primary endpoint and all secondary endpoints- -Study is a U.S. post-marketing commitment and will be submitted to FDA- -Data also will be submitted to the European Medicines Agency to support indication expansion of the EU label following triple combination approval- BOSTON
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Toggle Summary Vertex Announces Expansion of Reimbursement Agreement With NHS England to Include KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO® (ivacaftor)
-CF patients in England will be among the first in Europe to benefit from access to KAFTRIO ® , if the medicine is approved by the European Commission - LONDON --(BUSINESS WIRE)--Jun. 30, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has expanded its
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Toggle Summary CHMP Grants Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO® (ivacaftor) in People Ages 12 and Older With Cystic Fibrosis With the Most Common Genotypes
– If granted Marketing Authorization, people ages 12 and older in Europe who have one F508del mutation and one minimal function mutation will for the first time be able to benefit from a medicine that treats the underlying cause of the disease – – People 12 years of age and older who have two
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Toggle Summary Vertex and the Vertex Foundation Commit $4 Million to Support Racial Equity and Social Justice
- Vertex Foundation Announces $1.5 Million Gift to Boston University’s New Center for Antiracist Research - -Biotechnology-focused curriculum established in partnership with Year Up- -Additional commitments made to STEAM education- BOSTON --(BUSINESS WIRE)--Jun.
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Toggle Summary CRISPR Therapeutics and Vertex Announce New Clinical Data for Investigational Gene-Editing Therapy CTX001™ in Severe Hemoglobinopathies at the 25th Annual European Hematology Association (EHA) Congress
-Beta thalassemia: Two patients are transfusion independent at 5 and 15 months after CTX001 infusion; data demonstrate clinical proof-of-concept for CTX001 in transfusion-dependent beta thalassemia- -Sickle cell disease: Patient is free of vaso-occlusive crises at 9 months after CTX001 infusion-
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages of 6 Months and 18 Years With the R117H Mutation in the CFTR Gene
- KALYDECO ® (ivacaftor) is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual function mutation, in children as young as 6 months of age - LONDON --(BUSINESS WIRE)--Jun.
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Toggle Summary Vertex Appoints Diana McKenzie to its Board of Directors
BOSTON --(BUSINESS WIRE)--Jun. 3, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Diana McKenzie has been appointed to its board of directors as an independent director. Ms. McKenzie is a senior technology leader and innovator with deep experience across pharma,
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Toggle Summary New Data for Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001™ for Severe Hemoglobinopathies Accepted for Oral Presentation at the 25th European Hematology Association (EHA) Congress
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, May 14, 2020 (GLOBE NEWSWIRE) --  CRISPR Therapeutics  (Nasdaq: CRSP) and  Vertex Pharmaceuticals Incorporated  (Nasdaq: VRTX) today announced that new data from two ongoing Phase 1/2 clinical trials of the CRISPR/Cas9 gene-editing therapy CTX001 in
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Toggle Summary CRISPR Therapeutics and Vertex Pharmaceuticals Announce FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX001™ for the Treatment of Severe Hemoglobinopathies
CTX001 has received Orphan Drug Designation from the U.S. Food and Drug Administration for transfusion-dependent beta thalassemia and from the European Medicines Agency for sickle cell disease and transfusion-dependent beta thalassemia ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, May 11,
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Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages 6 Months and 18 Years With the R117H Mutation in the CFTR Gene
- If approved, KALYDECO ® (ivacaftor) will be the first and only medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual function mutation, as young as 6 months of age - LONDON --(BUSINESS WIRE)--May 1, 2020-- Vertex
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Toggle Summary Vertex Announces Virtual 2020 Annual Meeting and Internet Access to Proxy Materials
BOSTON --(BUSINESS WIRE)--Apr. 28, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that, due to public health and travel safety concerns related to the ongoing COVID-19 pandemic, its 2020 Annual Meeting of Shareholders will be held as a virtual meeting.
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Toggle Summary Vertex Pharmaceuticals and Affinia Therapeutics Establish Multi-Year Collaboration to Discover and Develop Novel AAV Capsids for Genetic Therapies
Affinia Therapeutics’ proprietary AAV vector technology to be used in Vertex’s genetic therapy efforts with focus on Duchenne muscular dystrophy, myotonic dystrophy type 1 and cystic fibrosis BOSTON & WALTHAM, Mass. --(BUSINESS WIRE)--Apr. 27, 2020-- Vertex Pharmaceuticals Incorporated
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Toggle Summary Vertex Announces Innovative Reimbursement Agreement in Switzerland for ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Cystic Fibrosis Patients
Agreement also enables the possibility of rapid patient access to future triple combination regimen (elexacaftor/tezacaftor/ivacaftor and ivacaftor) once approved in Switzerland LONDON --(BUSINESS WIRE)--Apr. 21, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has
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Toggle Summary The Vertex Foundation Commits $5 Million to Support Global COVID-19 Pandemic Response
BOSTON --(BUSINESS WIRE)--Apr. 7, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Vertex Foundation , a nonprofit charitable foundation, commits to make donations totaling $5 million in 2020 to support global COVID-19 relief efforts, including doubling its match
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Toggle Summary Vertex Confirms Supply Chain Continuity and Business Outlook for Its Cystic Fibrosis Medicines and Provides Initial Update on Development Programs
BOSTON --(BUSINESS WIRE)--Mar. 27, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today confirmed its 2020 business outlook and the continuity of the company’s supply chain for its approved cystic fibrosis (CF) medicines and provided an update on its development programs given the ongoing
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Toggle Summary The Vertex Foundation Donates $500,000 to Partners HealthCare to Support COVID-19 Outbreak Response
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Vertex Foundation , a nonprofit charitable foundation, is making a $500,000 gift to Partners HealthCare , a Boston -based nonprofit hospital and physician network, to support the needs of patients
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Toggle Summary Vertex Announces Availability of Cystic Fibrosis Medicine KALYDECO® (ivacaftor) in New Zealand
LONDON --(BUSINESS WIRE)--Feb. 25, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that KALYDECO ® (ivacaftor) will be available to eligible patients with cystic fibrosis (CF) in New Zealand from March 1 . Clinicians are able to apply for patient access using the
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Toggle Summary Vertex and Republic of Ireland Expand Long-Term Cystic Fibrosis Medicines Reimbursement Agreement to Include Triple Combination Therapy for All Eligible Patients Ages 12 and Over Once Licensed
LONDON --(BUSINESS WIRE)--Dec. 13, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today confirmed that, following recent collaborative discussions, it has negotiated an agreement with the Health Service Executive (HSE) in the Republic of Ireland to expand the existing long-term cystic
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) in Infants With Cystic Fibrosis Ages 6 Months to Less Than 12 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 children this young - LONDON --(BUSINESS WIRE)--Dec. 10, 2019-- Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label
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Toggle Summary French Authorities Approve National Reimbursement of ORKAMBI® (lumacaftor/ivacaftor) for Eligible People Ages Two and Older With Cystic Fibrosis
LONDON --(BUSINESS WIRE)--Nov. 20, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that the French Authorities (Comité économique des produits de santé, or CEPS ) have approved national reimbursement of ORKAMBI ® (lumacaftor/ivacaftor) for people ages two and older with
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Toggle Summary CRISPR Therapeutics and Vertex Announce Positive Safety and Efficacy Data From First Two Patients Treated With Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001® for Severe Hemoglobinopathies
-Two patients treated with CTX001 successfully engrafted and demonstrated an initial safety profile consistent with myeloablative busulfan conditioning and autologous hematopoietic stem cell transplant- -Beta thalassemia: Patient is transfusion independent with total hemoglobin level of 11.9 g/dL
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Toggle Summary Vertex and Molecular Templates Establish Collaboration to Discover and Develop Novel Targeted Conditioning Regimens to Enhance Hematopoietic Stem Cell Transplants
-Molecular Templates to receive $38 million upfront payment, including equity investment, with potential for additional milestone and royalty payments on future sales- BOSTON and AUSTIN, Texas, Nov. 18, 2019 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Molecular Templates, Inc.
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Toggle Summary Vertex Confirms Wales Offer Accepted for Access to All Licensed Cystic Fibrosis Medicines
-Eligible patients in Wales will soon have access to ORKAMBI ® (lumacaftor/ivacaftor) and SYMKEVI ® (tezacaftor/ivacaftor), expanded access to KALYDECO ® (ivacaftor) under same terms as NHS England agreement- LONDON --(BUSINESS WIRE)--Nov. 13, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq:
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Toggle Summary Vertex Confirms Northern Ireland Offer Accepted for Cystic Fibrosis Medicines
-Eligible patients in Northern Ireland will soon have access to ORKAMBI ® (lumacaftor/ivacaftor) and SYMKEVI ® (tezacaftor/ivacaftor), expanded access to KALYDECO ® (ivacaftor) under same terms as NHS England agreement- LONDON --(BUSINESS WIRE)--Nov. 12, 2019-- Vertex Pharmaceuticals Incorporated
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Toggle Summary Phase 3 Results from Two Studies of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Triple Combination Treatment for Cystic Fibrosis Concurrently Published in The New England Journal of Medicine and The Lancet
- Both studies met primary and all key secondary endpoints demonstrating significant improvements in lung function and other measures of the disease - - Results of both studies to be presented today at the 33rd Annual North American Cystic Fibrosis Conference as part of six presentations from
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Toggle Summary Vertex Announces European Medicines Agency Marketing Authorization Application Validation for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Triple Combination Treatment in Cystic Fibrosis
- Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations - LONDON --(BUSINESS WIRE)--Oct.
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Toggle Summary Vertex Announces Agreement with NHS England for Access to All Licensed Cystic Fibrosis Medicines
-Eligible patients in England will have access to ORKAMBI ® (lumacaftor/ivacaftor) and SYMKEVI ® (tezacaftor/ivacaftor), expanded access to KALYDECO ® (ivacaftor)- LONDON --(BUSINESS WIRE)--Oct. 24, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced an access agreement with
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Toggle Summary FDA Approves TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older Who Have at Least One F508del Mutation
- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA -approved
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Toggle Summary ADDING MULTIMEDIA FDA Approves TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older Who Have at Least One F508del Mutation
- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA -approved
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Toggle Summary Spanish Government Approves National Reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor) in Combination With KALYDECO® (ivacaftor)
LONDON --(BUSINESS WIRE)--Oct. 21, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that the Spanish Government has approved terms for the national reimbursement of ORKAMBI ® (lumacaftor/ivacaftor) and SYMKEVI ® (tezacaftor/ivacaftor) in combination with KALYDECO ®
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Toggle Summary Vertex Announces Reimbursement of Cystic Fibrosis Medicines SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Patients Ages 12 and Older, and ORKAMBI® (lumacaftor/ivacaftor) in Children Ages 2 to 5, With Certain CFTR Mutations in Australia
LONDON --(BUSINESS WIRE)--Oct. 19, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that SYMDEKO ® (tezacaftor/ivacaftor and ivacaftor) is reimbursed in Australia for people with cystic fibrosis (CF) ages 12 years and older who are homozygous for the F508del mutation or who
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Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Eligible Infants with Cystic Fibrosis as Early as 6 Months of Age
- If approved, ivacaftor will be the first and only medicine to treat the underlying cause of cystic fibrosis for children this young - LONDON --(BUSINESS WIRE)--Oct. 18, 2019-- Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for
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Toggle Summary Vertex Appoints Carmen Bozic, M.D., as New Chief Medical Officer and Nia Tatsis, Ph.D., as New Chief Regulatory Officer
  BOSTON --(BUSINESS WIRE)--Oct. 1, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Carmen Bozic , M.D., has been appointed as the company’s Executive Vice President, Global Medicines Development and Medical Affairs. Dr.
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Toggle Summary Vertex and Ribometrix Establish Strategic Collaboration to Discover and Develop RNA-Targeted Small Molecule Therapeutics
  -Partnership will leverage Ribometrix’s discovery platform for up to three therapeutic programs-     -Ribometrix to receive $20 million in upfront payment and Vertex equity investment; potential for additional milestones and royalty payments-     BOSTON & DURHAM, N.C. --(BUSINESS WIRE)--Sep.
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Toggle Summary FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
-FDA Grants Priority Review of the application and sets a PDUFA target action date of March 19, 2020 - -Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in
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Toggle Summary Vertex Announces Dr. Jeffrey Leiden to Transition to Role of Executive Chairman, Effective April 1, 2020 and Dr. Reshma Kewalramani Appointed as New Chief Executive Officer
BOSTON --(BUSINESS WIRE)--Jul. 25, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that its Board of Directors has approved the planned transition of Chairman, President and Chief Executive Officer Jeffrey Leiden , M.D., Ph.D, into the role of Executive Chairman of the
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Toggle Summary Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
-Application supported by positive results from two global Phase 3 studies in people with CF ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations- BOSTON --(BUSINESS WIRE)--Jul. 22, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq:
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