Vertex Pharmaceuticals

654 articles with Vertex Pharmaceuticals

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  Vertex Abandons VX-814 Program for Treating Rare Liver Disease

  10/15/2020

  Vertex Pharmaceuticals announced that after early data on its Phase II trial of VX-814 in Alpha-1 antitrypsin deficiency (AATD), it is halting the trial and ending development of the drug.

• FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age

  9/25/2020

  Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.

• 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

  9/22/2020

  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 investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy for the treatment of severe sickle cell disease (SCD). PRIME is a regulatory mechanism that provides early and proactive supp

• Moderna and Vertex Establish New Collaboration to Treat Cystic Fibrosis Using Gene Editing

  9/16/2020

  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 commercial milestones and royalty payments CAMBRIDGE & BOSTON, Mass.--( BUSINESS WIRE )-- Moderna, Inc. (Nasdaq:MRNA) and Vertex Pharmace

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  Clinical Catch-Up: September 7-11

  9/14/2020

  It was a busy week for clinical trial updates. Here’s a look.
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  Vertex's CF Blockbuster Trikafta Effective in Kids 6 to 11 Years of Age

  9/11/2020

  Based on the positive results, the company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter and other regulatory agencies around the world afterward.

• 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

  9/10/2020

  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 either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation, and based on the results will submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration

• 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

  9/1/2020

  Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted three supplemental New Drug Applications (sNDAs) for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor)

• European Commission Approves KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat Cystic Fibrosis in People Ages 12 Years and Older

  8/21/2020

  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

• Vertex Reports Second-Quarter 2020 Financial Results

  7/30/2020

  Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the second quarter ended June 30, 2020 and revised upward its full-year 2020 financial guidance for total cystic fibrosis (CF) product revenues.

• 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

  7/20/2020

  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 indic

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  BioSpace Movers & Shakers, July 17

  7/17/2020

  Biopharma and life sciences companies bolster their leadership teams and board with these Movers & Shakers.

• Vertex Pharmaceuticals Selects TRIA to Design Laboratory and Office for New 268,000 SF VCGT Research Site

  7/16/2020

   TRIA, a principal-led architecture firm with a focus on designing unique workspaces for science, technology, and corporate clients, announced today that it is designing a new cell and genetic therapies research site in the Boston area for Vertex Pharmaceuticals, Inc. (Nasdaq: VRTX)

• Vertex to Announce Second-Quarter 2020 Financial Results on July 30

  7/16/2020

  Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second-quarter 2020 financial results on Thursday, July 30, 2020 after the financial markets close. The company will host a conference call and webcast at 5:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International). The conference call will be webcast live and a link to the webcast can be accessed through Vertex'

• Vertex Announces Expansion of Reimbursement Agreement With NHS England to Include KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO® (ivacaftor)

  6/30/2020

  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 )-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has expanded its reimburs

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  Clinical Catch-Up: June 8-12

  6/15/2020

  It was a fairly busy week with clinical trial updates and announcements. Here’s a look.

• Vertex Appoints Diana McKenzie to its Board of Directors

  6/3/2020

  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, biotechnology and technology. She most recently served as Chief Information Officer of Workday, Inc., a cloud-based financial and human capital management software company. Prior

• Vertex Reports First-Quarter 2020 Financial Results

  4/29/2020

  Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the first quarter ended March 31, 2020 and revised upward its full-year 2020 financial guidance for total cystic fibrosis (CF) product revenues.

• Vertex Pharmaceuticals and Affinia Therapeutics Establish Multi-Year Collaboration to Discover and Develop Novel AAV Capsids for Genetic Therapies

  4/27/2020

  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 )-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) and Affinia Therapeutics announced today that the two companies have entered into a strategic research collaboration to engineer novel adeno-associated virus (AAV

• Vertex to Announce First-Quarter 2020 Financial Results on April 29

  4/20/2020

  Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first-quarter 2020 financial results on Wednesday, April 29, 2020 after the financial markets close. The company will host a conference call and webcast at 5:00 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International). The conference call will be webcast live and a link to the webcast can be accessed through Verte