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Toggle Summary Vertex Presents New Phase 3 Data that Showed People with Hepatitis C Treated with Twice-Daily Telaprevir Achieved Viral Cure (SVR12) Rates Similar to Those Treated Three Times Daily
- New Phase 2 data showed approximately 3 of 4 people co-infected with hepatitis C virus (HCV) and HIV achieved HCV viral cure (SVR24) with telaprevir combination treatment - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that new data from a Phase 3
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Toggle Summary Data from Viral Kinetic Study Showed Rapid Reduction of HCV RNA with ALS-2200 (VX-135), Vertex's Oral Nucleotide Analogue in Development for the Treatment of Hepatitis C
- 4.54 log 10 median reduction in HCV RNA after 7 days of dosing; ALS-2200 was well-tolerated with no serious adverse events and no discontinuations due to adverse events - - Vertex moving forward with multiple Phase 2 trials in early 2013 exploring all-oral combinations, including VX-135 with
HCV
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Toggle Summary Vertex Reports Third Quarter 2012 Financial Results and Recent Progress in Development Programs
-Third quarter 2012 total revenues of $336 million , including third quarter 2012 net product revenues of approximately $254 million for INCIVEK in hepatitis C and $49 million for KALYDECO in cystic fibrosis- -Cystic Fibrosis: Three ongoing Phase 3 label expansion studies for ivacaftor monotherapy;
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Toggle Summary Vertex Enters Agreement with GlaxoSmithKline for Phase 2 All-Oral Study of VX-135 and GSK2336805 for the Treatment of Hepatitis C
-Companies to evaluate two-drug combination of Vertex's investigational nucleotide analogue VX-135 and GSK's investigational NS5A inhibitor GSK2336805- -Phase 2 proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12-week treatment regimen-
HCV
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Toggle Summary Vertex Announces Collaboration with Janssen To Initiate Phase 2 All-Oral Study of VX-135 and Simeprevir (TMC435) for the Treatment of Hepatitis C
-Companies to evaluate two-drug combination of Vertex's investigational nucleotide analogue VX-135 and Janssen's investigational protease inhibitor simeprevir (TMC435)- -Phase 2 proof-of-concept study to begin in early 2013 to evaluate safety, tolerability and viral cure rates of 12-week treatment
HCV
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Toggle Summary Vertex Announces the Date of its Third Quarter 2012 Financial Results Conference Call and Webcast
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will announce its third quarter 2012 financial results on Monday, October 29, 2012 after the financial markets close. The company will host a conference call at 5:00 p.m. EDT .
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Toggle Summary Data from Phase 2 Combination Study of VX-809 and Ivacaftor in People with Cystic Fibrosis Who Have the Most Common Genetic Mutation (F508del) Presented at North American Cystic Fibrosis Conference
-- Additional KALYDECO™ (ivacaftor) and CF pipeline presentations highlight Vertex's commitment to advancing CF treatment by targeting the underlying cause of the disease -- ORLANDO, Fla. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data from a Phase 2
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Toggle Summary Vertex Announces Presentation of New Data from Hepatitis C Development Program at AASLD Annual Meeting
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 11 abstracts from its hepatitis C research and development program will be presented at The Liver Meeting ® , the 63rd Annual Meeting of the American Association for the Study of Liver
HCV
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Toggle Summary Vertex Announces Presentation of Data at North American Cystic Fibrosis Conference
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 10 abstracts from its cystic fibrosis (CF) research and development program will be presented at the 26th Annual North American Cystic Fibrosis Conference (NACFC) in Orlando, Fla.
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Toggle Summary Vertex Announces New Data on ALS-2200 in People With Hepatitis C, Supporting Advancement into Phase 2 All-Oral Studies in 2012; Ends Development of ALS-2158
- ALS-2158: Well-tolerated in a seven-day viral kinetic study; development discontinued due to lack of efficacy - - ALS-2200: Data from additional cohort of seven-day viral kinetic study with ALS-2200 (200 mg, QD) in combination with ribavirin show median 4.18 log 10 reduction in HCV RNA with 5 of
HCV
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Toggle Summary Yuchun Lee Appointed to the Vertex Board of Directors
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Yuchun Lee joined its board of directors as an independent director. Mr. Lee was appointed to the class of directors whose term expires in 2013.
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Toggle Summary Vertex Announces Appointment of Stuart A. Arbuckle as Chief Commercial Officer
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced the appointment of Stuart A. Arbuckle as Executive Vice President and Chief Commercial Officer. Mr. Arbuckle has more than 25 years of experience in leading global sales and marketing efforts at
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Toggle Summary Vertex Reports Second Quarter 2012 Financial Results and Provides Updates on Progress in Research and Development Programs in Hepatitis C and Cystic Fibrosis
-Second quarter 2012 total revenues of $418 million , including second quarter 2012 net product revenues of approximately $328 million for INCIVEK in hepatitis C and $46 million for KALYDECO in cystic fibrosis; company revises financial guidance for full-year 2012 INCIVEK net revenues- -Cystic
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Toggle Summary Vertex Announces Positive Results from Viral Kinetic Study of the Nucleotide Analogue ALS-2200 in People with Hepatitis C
- 4.54 log 10 median reduction in HCV RNA observed in people with genotype 1 hepatitis C treated with a once-daily 200 mg dose of ALS-2200 for seven days; treatment was well-tolerated- - Phase 2 studies of 12-week all-oral regimens planned for this year - CAMBRIDGE, Mass.
HCV
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Toggle Summary Vertex Receives European Approval for KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People With a Specific Genetic Mutation (G551D)
- European Commission approval comes two months after positive CHMP opinion - GENEVA --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has approved KALYDECO TM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who
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Toggle Summary Final Data from Phase 2 Combination Study of VX-809 and KALYDECO™ (ivacaftor) Showed Statistically Significant Improvements in Lung Function in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation
- Mean absolute improvement in lung function of 6.1 percentage points within group (p < 0.001) and 8.6 percentage points compared to placebo (p < 0.001) in homozygous patients receiving combination treatment (Day 28 to 56) with highest study dose of VX-809 (600mg) - - Adverse events were
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Toggle Summary Vertex Announces Collaboration with the Boston Public Schools to Enhance Science Education
- Vertex commits more than $1 million to support education for BPS students and to prepare teachers for new science education standards- -Company dedicates 3,000 square foot learning laboratory at new Fan Pier headquarters to local community- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals
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Toggle Summary Vertex Appoints Ken Horton as Executive Vice President and Chief Legal Officer and Announces Retirement of Nancy Wysenski as Chief Commercial Officer
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced two changes to its executive leadership team. Following a comprehensive search, Vertex has appointed Kenneth Horton to the role of Chief Legal Officer, where he will take on the additional title
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Toggle Summary Data From Follow-Up Study of KALYDECO™ (ivacaftor) Showed Durable Improvements in Lung Function and Other Measures of Disease in People with Cystic Fibrosis Who Have a Specific Genetic Mutation (G551D)
- Data from nine presentations at the European Cystic Fibrosis Society Conference underscore Vertex's ongoing commitment to change CF treatment by targeting the underlying cause of the disease - DUBLIN --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today new data
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Toggle Summary Vertex Corrects and Provides Additional Data from Recent Interim Analysis of Phase 2 Combination Study of VX-809 and KALYDECO™ (ivacaftor) in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation
- Corrected Data: Responder analysis showed 35% of patients experienced an absolute improvement in lung function (FEV 1 ) of at least 5 percentage points and 19% had at least a 10 percentage-point improvement when treated with VX-809 and KALYDECO - - Additional Data: Patients treated with VX-809
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Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis
- Global studies showed significant and sustained improvements in lung function and other measures of disease among people with a specific genetic mutation - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Committee for
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Toggle Summary Vertex Appoints David Altshuler, M.D., Ph.D., to its Board of Directors
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that David Altshuler , M.D., Ph.D., joined its board of directors as an independent director. Dr. Altshuler was appointed to the class of directors whose term expires in 2015.
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Toggle Summary The Crohn's and Colitis Foundation of Canada and Vertex Announce Collaboration to Fund Research in Inflammatory Bowel Disease
-Unique collaboration between a biotech company, nonprofit organization and academic centres to focus on underlying biology of IBD-<br> -Collaboration complements Vertex's ongoing IBD research efforts at its Canadian research and development site-
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Toggle Summary Interim Data from Phase 2 Combination Study of VX-809 and KALYDECO™ (ivacaftor) Showed Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation
  - 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 - - Vertex plans to start a pivotal study of VX-809 and KALYDECO to treat the underlying cause of CF in
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Toggle Summary Vertex Reports First Quarter 2012 Financial Results and Provides Update on Launch of KALYDECO™
-Approximately 600 people with cystic fibrosis have started treatment with KALYDECO since approval on January 31 - -Multiple ongoing clinical trials to generate data beginning in second quarter, including study of KALYDECO combined with VX-809 in cystic fibrosis and first data for Alios nucleotides
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Toggle Summary INCIVEK™ (telaprevir) Now Funded for People With Hepatitis C in Quebec and Saskatchewan
- Vertex working with other provincial funding agencies to make INCIVEK available to more people in Canada - LAVAL, Quebec --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the province of Quebec is now funding INCIVEK ™ (telaprevir) tablets for residents
HCV
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Toggle Summary Vertex Advances INCIVEK™ (telaprevir) and Broad Portfolio of Medicines in Development With Goal of Further Expanding and Improving Treatment for People With Hepatitis C
- Subanalysis of Phase 2 data shows 12 weeks of INCIVEK combination treatment resulted in a viral cure (SVR) for 100% of people with hepatitis C who had the IL28B CC genotype; Phase 3 study enrolling - - Vertex's four direct-acting antivirals allow for the clinical exploration of multiple
HCV
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Toggle Summary Data from Phase 2 Study of an INCIVEK® Combination Regimen Showed 74% of People Co-Infected with Hepatitis C and HIV Had Undetectable Hepatitis C Virus 12 Weeks After Treatment Ended (SVR12)
- INCIVEK was well tolerated with commonly used Atripla- and Reyataz-based HIV treatment regimens, and no patients experienced HIV breakthrough - - Enrollment is ongoing in Phase 3 study evaluating 24- and 48-week treatment durations in people who are co-infected - SEATTLE --(BUSINESS WIRE)--
HCV
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Toggle Summary Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C
- Company plans to start Phase 2b study in Q3 2012 to evaluate this interferon-free combination regimen in a total treatment duration as short as 12 weeks - - Vertex also announces the advancement of its broad portfolio of direct acting antivirals, including its two structurally-distinct nucleotide
HCV
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Toggle Summary Vertex Reports Fourth Quarter and Full-Year 2011 Financial Results
-Successful launch of INCIVEK (telaprevir) for hepatitis C and recent approval of KALYDECO (ivacaftor) for cystic fibrosis position Vertex for continued growth, earnings and cashflow- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated
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Toggle Summary FDA Approves KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis
- FDA approval received 3 months after submission of New Drug Application - - KALYDECO approved to treat people with CF who have a specific genetic mutation - - Vertex launches a comprehensive financial assistance and patient support program - CAMBRIDGE, Mass.
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Toggle Summary Vertex Announces Key 2012 Business Objectives as Company Prepares for Planned Global Launch of KALYDECO in Cystic Fibrosis
-More than 25,000 people have started treatment for hepatitis C with INCIVEK ® , positioning Vertex for continued growth, earnings and cashflow in 2012- -Preparations for approval and launch of KALYDECO TM ongoing; additional studies of KALYDECO planned for mid-2012- -Nine new medicines in
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Toggle Summary FDA Grants Priority Review for KALYDECO™ (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis
-- Six-month review date of April 18, 2012 set by FDA -- -- European Medicines Agency accepts KALYDECO regulatory submission for accelerated assessment -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S.
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Toggle Summary Vertex Announces CEO Succession Plan for 2012
- Jeffrey Leiden , M.D., Ph.D., to become CEO in February 2012 - - Matthew Emmens elects to retire in May; will remain director for Vertex Board- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that its Board of Directors has appointed Jeffrey
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Toggle Summary Vertex and Alios BioPharma Begin Clinical Studies of Nucleotide Drug Candidates ALS-2200 and ALS-2158 for the Treatment of Hepatitis C
-Studies to evaluate safety and effects on viral kinetics in people with chronic genotype-1 hepatitis C- -Data expected in second quarter of 2012 could enable initiation of interferon-free, nucleotide-based combination studies in the second half of 2012- CAMBRIDGE, Mass.
HCV
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Toggle Summary Phase 2 Data for Selective Oral JAK3 Inhibitor VX-509 Show Significant Improvements in Signs and Symptoms of Rheumatoid Arthritis
-Data to be presented at American College of Rheumatology Annual Meeting next week- -Phase 2b study evaluating longer treatment duration for VX-509 planned for early 2012- CHICAGO --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the final results from a Phase
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Toggle Summary Interim Data from Phase 2 Study Showed 93% of People with Hepatitis C Who Received a Total of 12 Weeks of a Combination Regimen Including INCIVEK™ (telaprevir) and VX-222 (400mg) Achieved a Viral Cure (SVR)
- Vertex announces it intends to start a Phase 3 study to evaluate a 12-week regimen in treatment naive and relapser patients with genotype 1 hepatitis C - SAN FRANCISCO --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today interim results from ZENITH, an ongoing
HCV
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Toggle Summary Positive Interim Data From a Phase 2 Study of INCIVEK™ (telaprevir) Combination Therapy in People Co-Infected with Hepatitis C and HIV Presented at The Liver Meeting®
- Data showed 74% of people had undetectable hepatitis C virus 24 weeks after starting INCIVEK combination treatment - - Vertex to initiate Phase 3 study to evaluate 24- and 48-week treatment durations in people who are co-infected - SAN FRANCISCO --(BUSINESS WIRE)-- Vertex Pharmaceuticals
HCV
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Toggle Summary Vertex Announces Recipients of Special Grants Initiative to Support People with Hepatitis C
- Hep-C Circle of Care grants will fund new and existing programs with the potential to enhance patient care - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has awarded 16 grants totaling approximately $1.5 million to a variety of
HCV
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Toggle Summary Phase 3 Study of KALYDECO™ (ivacaftor) in Children Ages 6 to 11 with a Specific Type of Cystic Fibrosis Showed Significant Improvements in Lung Function and Other Measures of Disease Sustained Through 48 Weeks
- Additional presentations at the North American CF Conference include data from PERSIST that showed sustained safety and efficacy of KALYDECO through 60 weeks of treatment among adolescents and adults treated in the Phase 3 STRIVE study - ANAHEIM, Calif.
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Toggle Summary Data from the First Part of a Phase 2 Study Support the Approach of Treating the Most Common Form of Cystic Fibrosis (F508del) by Targeting the Underlying Cause of the Disease With a Combination of KALYDECO™ (ivacaftor) and VX-809
- New data at North American CF Conference showed a reduction in sweat chloride when KALYDECO was added to VX-809 in people with the F508del mutation — - Part 2 of study now enrolling patients - ANAHEIM, Calif. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced
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Toggle Summary 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
  - 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. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that the New England Journal of
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Toggle Summary Vertex Reports Profitable Third Quarter and Provides Updates on INCIVEKTM (telaprevir) Launch and Medicines in Development
- $420 million in net product revenues for INCIVEK for the first full quarter since launch- -Continued strength in launch of INCIVEK for hepatitis C; submissions of KALYDECO TM (VX-770, ivacaftor) approval applications complete- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals
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Toggle Summary Vertex Announces Presentation of New Data for Oral JAK3 Inhibitor VX-509 at Annual Meeting of the American College of Rheumatology
-Final data to be presented from Phase 2 study in rheumatoid arthritis- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that two abstracts related to its investigational oral JAK3 inhibitor, VX-509, will be presented at the 2011 Annual Meeting
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Toggle Summary Vertex Starts Global Phase 3b Study to Evaluate the Potential for People with Hepatitis C to Achieve a Viral Cure (SVR) with a Total Treatment Duration of 12 Weeks of INCIVEK™ Combination Therapy
— CONCISE study will evaluate twice-daily INCIVEK in combination with pegylated-interferon and ribavirin among patients new to treatment and prior relapsers who have the ‘CC' variation near the IL28B gene — CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
HCV
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Toggle Summary Vertex Submits Application for Priority Review and Approval of KALYDECO™ (VX-770, ivacaftor) in the U.S. as First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis
-- Accelerated assessment of KALYDECO granted by the European Medicines Agency ; MAA submission planned in EU by the end of October -- -- Phase 3 registration studies of KALYDECO showed significant improvements in lung function and other measures of disease among a subset of people with CF --
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Toggle Summary INCIVEK&#153; (telaprevir) Now Available in Canada for People with Hepatitis C
Nearly 4 out of 5 people treated for the first time cleared the virus with INCIVEK combination treatment
HCV
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Toggle Summary Vertex Announces Presentation of New Data on VX-770 and VX-809 at North American Cystic Fibrosis Conference
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that nine abstracts from its cystic fibrosis (CF) research program, which is aimed at discovering and developing medicines that target the underlying cause of CF, will be presented at the 25th
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Toggle Summary Vertex Named Top Biopharma Employer by Science
-Vertex hiring for 150 jobs across the company to support global growth; Company plans to add more than 500 jobs through 2015- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Science has ranked the company #1 in the magazine's annual list
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Toggle Summary New England Journal of Medicine Publishes Data from Phase 3 ILLUMINATE Study of INCIVEK™ (telaprevir) in Hepatitis C
- High viral cure rate achieved with a 24-week INCIVEK combination regimen - CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from a Phase 3 study of INCIVEK™ (telaprevir) tablets
HCV
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