-Mean absolute improvement in ppFEV 1 of 14.0 percentage points from baseline at week 4 in people with one F508del mutation and one minimal function mutation compared to placebo (p
-Approximately 2,400 children ages 6 to 11 have two copies of the F508del mutation in the U.S. - -Target review date of September 30, 2016 set for the FDA's decision on the application- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that the U.S.
-Six-month review date of May 23, 2011 set by FDA- CAMBRIDGE, Mass., Jan 20, 2011 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration ( FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the
--Approximately 500 people with cystic fibrosis ages 6 and older have the R117H mutation in the United States -- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug
-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
-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.
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
– 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.
- 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
- 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.
