-SYMDEKO is now approved for patients 6 years of age and older with two copies of the F508del mutation or one copy of a responsive mutation- -Vertex's third medicine approved to treat the underlying cause of CF in eligible patients in this age range- BOSTON --(BUSINESS WIRE)--Jun.
- 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
FDA Grants Fast Track Designation to Vertex’s Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 Cambridge, MA, December 8, 2005 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to
FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 Cambridge, MA, December 8, 2005 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to
-- 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.
Federal Court Orders Dismissal of Shareholder Lawsuit Against Vertex Pharmaceuticals Cambridge, MA, February 23, 2005 --Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the United States District Court for the District of Massachusetts has granted its motion to dismiss a
- 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
Two Large Phase 2 Trials of Telaprevir, an Investigational Hepatitis C Protease Inhibitor, Dosed in Combination with Pegylated Interferon and Ribavirin Show SVR Rates of 61% and 65% Initial Rapid Viral Decline Appears Important to Achieve SVR Safety Profile Consistent with Prior Interim Analyses
- FDA decision expected by July 5, 2015 PDUFA date- -Approximately 8,500 people with cystic fibrosis in the U.S. have two copies of the F508del mutation and are ages 12 and older- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S.
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
GlaxoSmithKline and Vertex Pharmaceuticals Announce Preliminary 48-Week Results from Head-to-Head Clinical Study of HIV Protease Inhibitors Lexiva (Telzir) and Kaletra in Treatment-naive Patients with HIV Research Triangle Park, NC, and Cambridge, MA, May 16, 2006 -- GlaxoSmithKline (GSK) and
GlaxoSmithKline and Vertex Receive European Approval for Telzir(R), a New Protease Inhibitor for the Treatment of HIV London, UK, July 16, 2004 -- GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that they have received marketing approval from the
GSK and Vertex Pharmaceuticals Receive European CPMP Positive Opinion for Telzir(R) Cambridge, MA, March 25, 2004 -- GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that they have received a positive opinion from the European Committee for Proprietary
- Nearly 4 out of 5 people treated for the first time cleared the virus with INCIVEK combination treatment - CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has approved INCIVEK™ (telaprevir) tablets for a broad group of
-- Approximately 100 people in Canada have the G551D mutation in the CFTR gene -- -- First medicine resulting from 1989 co-discovery of CF gene by researchers in Canada and the U.S. -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that
-Approximately 1,500 people in Canada are ages 12 and older and have two copies of the F508del mutation, the most common genetic form of the disease- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has approved Pr ORKAMBI ®
-SYMDEKO is Vertex’s third medicine to treat the underlying cause of CF- -Approximately 2,000 people in Canada are ages 12 and older and have two copies of the F508del mutation or at least one mutation in the CF gene that is responsive to treatment with SYMDEKO- BOSTON --(BUSINESS WIRE)--Jun.
-KALYDECO is the first and only approved medicine in Canada to treat the underlying cause of cystic fibrosis in these young patients- BOSTON --(BUSINESS WIRE)--Jan. 28, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has granted Market Authorization for
- 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
-Approximately 500 Canadians ages 6-11 are now eligible for TRIKAFTA ® - - Vertex has submitted this indication to CADTH & INESSS for Health Technology Assessments- BOSTON --(BUSINESS WIRE)--Apr. 20, 2022-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has
-Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their disease- BOSTON --(BUSINESS WIRE)--Jun. 18, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced Health Canada has granted Marketing Authorization for TRIKAFTA ®
<i>-VX-222 was well-tolerated across all four dose groups through three
days of dosing, with all adverse events being mild to moderate in
severity-</i>
<br />
<i>-Greater than 3 log</i><sub><i>10 </i></sub><i>reduction in HCV RNA
observed across all four VX-222 dose groups-</i>
<br />
<i>-Results support previously announced Phase 2 proof-of-concept
clinical trial evaluating VX-222 in combination with Vertex's lead HCV
protease inhibitor telaprevir-</i>
<br />
- 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
- 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
-First data to show potential for viral cure in many patients with a 12-week combination regimen of multiple direct-acting antivirals- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from ZENITH, an ongoing Phase 2 study
- 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
-13.17 mmol/L reduction in sweat chloride in one arm supports further evaluation of a combination approach to treating the root cause of cystic fibrosis- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from the first part of a
BERLIN--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from an ongoing Phase 2 study (ZENITH) designed to assess the safety and tolerability of 12-week response-guided treatment regimens with its polymerase inhibitor, VX-222, and its protease
<ul><li class="bwlistitemmarginbottom"><i><b>57% of prior treatment null responder patients achieved an SVR
with a 48-week telaprevir-based regimen</b></i></li><li class="bwlistitemmarginbottom"><i><b>90% of prior treatment relapsers and 55% of prior treatment
partial responders achieved an SVR with 24-week or 48-week
telaprevir-based regimens</b></i></li><li class="bwlistitemmarginbottom"><i><b>Results provide further support for the ongoing Phase 3
registration study, REALIZE, in treatment-failure patients</b></i></li></ul>
CAMBRIDGE, Mass., Jul 07, 2009 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that Jeffrey Leiden, M.D., Ph.D. and Dennis Winger joined its board of directors. "Jeff and Dennis add tremendous medical and biomedical business perspective to our board.
Merck & Co., Inc. and Vertex Announce Broad Collaboration to Develop and Commercialize VX-680, a Novel Compound for the Treatment of Cancer Whitehouse Station, NJ and Cambridge, MA, June 22, 2004 -- Merck & Co., Inc. (NYSE: MRK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today
-Merck KGaA, Darmstadt, Germany licenses two promising clinical-stage programs targeting DNA damage and repair, and two novel pre-clinical programs- -Vertex receives upfront payment of $230 million plus royalties on future sales- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated
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
<ul><li class="bwlistitemmarginbottom"><i><b>83% SVR achieved with twice-daily regimen of telaprevir dosed
with PEGASYS and ribavirin</b></i></li><li class="bwlistitemmarginbottom"><i><b>Results highlight the use of response-guided therapy in managing
treatment outcomes</b></i></li><li class="bwlistitemmarginbottom"><i><b>Similar safety and tolerability observed between
telaprevir-based regimens dosed either twice daily or three times daily</b></i></li></ul>
New Clinical Data Support Broad Profile for Telaprevir in Patients with Genotype 1 Hepatitis C Virus (HCV) Infection PROVE 3 data show 52% SVR12 in HCV treatment-failure patients with 24-week treatment duration PROVE 2 final results confirm 69% SVR in HCV treatment-naïve patients with 24-week
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
