Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral,...
(Source: Johnson & Johnson) July 23, 2015 Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir Filing Supported...
View ArticleJanssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral,...
TITUSVILLE, N.J., July 23, 2015 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the submission of a supplemental New Drug Application (sNDA) to the...
View ArticleYour Story, Your HIV Wisdom™ Brings Together HIV Voices and Supports HIV...
(Source: Johnson & Johnson) Notable HIV Advocates Highlight Perspectives of People Living with or Affected by HIV to Leverage Shared Support and Self-Expression TITUSVILLE, N.J., September 8, 2015...
View ArticleYour Story, Your HIV Wisdom™ Brings Together HIV Voices and Supports HIV...
TITUSVILLE, N.J., Sept. 8, 2015 /PRNewswire/ -- Seeking and sharing information are important parts of the HIV journey – in fact, 80 percent of people living with HIV said they give advice or tell...
View ArticleU.S. FDA Approves PREZISTA® (darunavir) for Use in Pregnant Women with HIV...
(Source: Johnson & Johnson) Data shows PREZISTA is a safe and effective treatment option in pregnant women, with no reports of mother-to-child HIV transmission among women who continued therapy...
View ArticleTECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) Receives FDA...
(Source: AbbVie Inc) - TECHNIVIE provides an opportunity to treat adults in the U.S. who have genotype 4 (GT4) chronic hepatitis C virus (HCV) infection without cirrhosis, a population historically...
View ArticleTECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) Receives FDA...
NORTH CHICAGO, Ill., July 24, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global, research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved...
View ArticleEnanta Announces Data to be Presented on AbbVie’s MAVYRET™...
16 HCV abstracts to be presented including 12 data presentations on the safety and efficacy of MAVYRET MAVYRET is recommended in new AASLD guidelines as a first line treatment option for 8 weeks in...
View ArticleMerck Receives Approval of ZEPATIER™ (elbasvir/grazoprevir) in Canada for the...
(Source: Merck Canada Inc) 00f0678e-090a-4f9c-a736-8cbc159b1544.pdf News Release FOR IMMEDIATE RELEASE Media Contact: Annick Robinson (438) 837-2550 Investor Contact: Amy Klug (908) 740-1898 Merck...
View ArticleEnanta Announces New Data from AbbVie’s SURVEYOR-1 and SURVEYOR-2 Studies...
(Source: Enanta Pharmaceuticals Inc) 97-98 percent SVRachieved with eight weeks of ABT-493 and ABT-530 treatment ingenotypes 1, 2 or 3 HCV patients without cirrhosis in SURVEYOR 1 and 2 studies 100...
View ArticleU.S. FDA Approves Expanded Use of Bristol-Myers Squibb’s Daklinza...
(Source: Bristol-Myers Squibb Company) PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex...
View ArticleFDA approves Technivie for treatment of chronic hepatitis C genotype 4 (FDA -...
(Source: FDA - Food and Drug Administration) Release The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for...
View ArticleEnanta Pharmaceuticals Announces Investigational Regimen Containing Enanta’s...
(Source: Enanta Pharmaceuticals Inc) Data from AbbVie’s SURVEYOR-I and SURVEYOR-II studies demonstrate high sustained virologic response rates at 12 weeks post-treatment (SVR 12 ) in non-cirrhotic...
View ArticleEight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic,...
(Source: AbbVie Inc) - 99 percent (n=105/106) of genotype 1 (GT1) chronic HCV-infected Japanese patients without cirrhosis achieved SVR[12] with 8 weeks of G/P - Japan has one of the highest rates of...
View ArticleAbbVie's HOLKIRA™ PAK Now Reimbursed in Quebec
HOLKIRA PAK is now listed in the drug formularies covered by Quebec's public prescription drug insurance program for patients with genotype 1 hepatitis C virus infection. In Phase 3 clinical trials,...
View ArticleAbbVie Announces High Sustained Virologic Response Rates in Phase 2 Studies...
(Source: AbbVie Inc) NORTH CHICAGO, Ill., Nov. 16, 2015/PRNewswire / -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced data from the SURVEYOR studies of its investigational...
View ArticleAbbVie Updates U.S. Labels for VIEKIRA PAK® and TECHNIVIE™ (AbbVie Inc)
(Source: AbbVie Inc) NORTH CHICAGO, Ill., Oct. 22, 2015/PRNewswire / -- In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir,...
View ArticleEnanta Pharmaceuticals Announces HCV Data Presentations at The International...
(Source: Enanta Pharmaceuticals Inc) New data to be presented on EDP-494, Enanta's pan-genotypic cyclophilin inhibitor for Hepatitis C virus New data to be presented on AbbVie's investigational,...
View ArticleAbbVie Updates U.S. Labels for VIEKIRA PAK® and TECHNIVIE(TM)
NORTH CHICAGO, Ill., Oct. 22, 2015 /PRNewswire/ -- In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir, paritaprevir, and...
View ArticleAbbVie Updates U.S. Labels for VIEKIRA PAK® and TECHNIVIE™
NORTH CHICAGO, Ill., Oct. 22, 2015 /PRNewswire/ -- In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir, paritaprevir, and...
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