-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.
-Vertex gains worldwide rights to two distinct nucleotide analogues, ALS-2200 and ALS-2158, that act on hepatitis C polymerase- -Collaboration provides multiple opportunities to develop new "all-oral" combination regimens- CAMBRIDGE, Mass. , & SOUTH SAN FRANCISCO, Calif.
- VX-548 advances into pivotal development for people with acute pain ; Phase 3 program to initiate in Q4 2022 - - Phase 2 dose-ranging trial in neuropathic pain expected to initiate by year end - -Breakthrough Therapy Designation granted by FDA - BOSTON --(BUSINESS WIRE)--Jul.
– Single pivotal trial to initiate later this month targets the broad patient population with two APOL1 mutations and proteinuric kidney disease – – Pathway for accelerated approval using an interim analysis at Week 48 of eGFR slope, supported by reduction in proteinuria – – Final analysis
- Initiates first-in-human trial of next-wave AAT corrector, VX-634 - - Phase 2 study evaluating the impact of longer-term treatment with VX-864 to be initiated in the coming weeks - - Additional AAT correctors to enter the clinic starting in 2023 - BOSTON --(BUSINESS WIRE)--Oct.
- 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
– 45 mg once daily oral dose selected for Phase 3 – – Results support trial expansion to lower age group and study will now include adolescents ages 10-17 years – – If positive, pre-planned interim analysis at Week 48 may serve as the basis for accelerated approval in the U.S.
Updated HIV Treatment Guidelines Now Include LEXIVA(R) (fosamprenavir calcium)/r for Initial Antiretroviral Treatment Regimens Toronto, Canada, August 13, 2006 -- Updated treatment guidelines issued today by the International AIDS Society-USA (IAS-USA) now include the HIV protease inhibitor
-Approximately 2,400 children ages 6 through 11 have two copies of the F508del mutation in the U.S. - - Vertex revises ORKAMBI revenue guidance for 2016 - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S.
-KALYDECO is the first medicine to treat the underlying cause of CF for people with specific mutations in the CFTR gene- -KALYDECO facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein- -The eight additional mutations are present in
