Enanta Pharmaceuticals Announces FDA Acceptance of AbbVie’s New Drug...
(Source: Enanta Pharmaceuticals Inc) Decision from FDA on New Drug Application anticipated in second half of 2016 Regimen contains Enanta’s lead protease inhibitor, paritaprevir WATERTOWN,...
View ArticleEnanta Announces New Data on VIEKIRA PAK® (ombitasvir, paritaprevir,...
(Source: Enanta Pharmaceuticals Inc) AbbVie’s ongoing TOPAZ-II study evaluates long-term treatment outcomes in genotype 1a and genotype 1b chronic HCV patients with or without compensated cirrhosis...
View ArticleU.S. FDA Grants Priority Review to AbbVie for Supplemental New Drug...
NORTH CHICAGO, Ill., Jan. 7, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental...
View ArticleEnanta Pharmaceuticals Announces the U.S. FDA Grants Priority Review to...
(Source: Enanta Pharmaceuticals Inc) Priority review designation shortens the regulatory review period from the standard 10 months to six months TURQUOISE-III study showed 100 percent sustained...
View ArticleFDA Grants Priority Review to AbbVie for Supplemental New Drug Application...
(Source: AbbVie Inc) NORTH CHICAGO, Ill., Jan. 7, 2016/PRNewswire / -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has...
View ArticleAbbVie to Present Data on VIEKIRAX® (ombitasvir/paritaprevir/ritonavir...
(Source: AbbVie Inc) Mar 30, 2016 NORTH CHICAGO, Ill., March 30, 2016 /PRNewswire / -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that 25 abstracts have been accepted for...
View ArticleAbbVie Announces Real-World Data with VIEKIRAX®...
BARCELONA, Spain, April 15, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new real-world data showing 96 percent of genotype 1 (GT1) patients (n=486/505...
View ArticleEnanta Announces High SVR Rates with AbbVie’s VIEKIRAX® + EXVIERA® Regardless...
(Source: Enanta Pharmaceuticals Inc) 100 percent of genotype 1b (GT1b) patients who received VIEKIRAX + EXVIERA without ribavirin for 12 weeks, achieved SVRin a post-hoc analysis,regardless of whether...
View ArticleAbbVie Receives CHMP Positive Opinion for VIEKIRAX®...
NORTH CHICAGO, Ill., Feb. 26, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of...
View ArticleAbbVie Receives CHMP Positive Opinion for VIEKIRAX®...
NORTH CHICAGO, Ill., Feb. 26, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of...
View ArticleAbbVie Announces High SVR Rates with VIEKIRAX®...
BARCELONA, Spain, April 14, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced data showing that patients with genotype 1 (GT1) chronic hepatitis C virus...
View ArticleEnanta Announces the U.S. Food and Drug Administration has approved AbbVie’s...
(Source: Enanta Pharmaceuticals Inc) New once-daily, extended-release co-formulation contains the three direct-acting antiviral components of VIEKIRA PAK® for adult patients with genotype 1 (GT1)...
View ArticleEnanta Announces U.S. FDA has Approved AbbVie’s Supplemental New Drug...
(Source: Enanta Pharmaceuticals Inc) Approval supported by TURQUOISE-III study showing 100 percent SVR (N=60/60) in chronic hepatitis C virus (HCV) infected genotype 1b patients with compensated...
View ArticleEnanta Pharmaceuticals Announces Data on Eight-Week Treatment of AbbVie’s...
(Source: Enanta Pharmaceuticals Inc) AbbVie reports 98 percent of previously untreatedgenotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVRin Phase 3b...
View ArticleU.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral,...
NORTH CHICAGO, Ill., April 24, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority...
View ArticleU.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral,...
- The New Drug Application (NDA) was accepted by the U.S. Food and Drug Administration (FDA) and is based on results from the PEARL-I study, which demonstrated up to 100 percent sustained virologic...
View ArticleCombination Therapy Approved for Chronic Hepatitis C Infection (ASHP -...
(Source: ASHP - American Society of Health-System Pharmacists) BETHESDA, MD 22 Dec 2014- FDA and AbbVie on December 19 announced the approval of Viekira Pak, a four-drug oral combination product for...
View ArticleEuropean Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX®...
NORTH CHICAGO, Ill., Jan. 16, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free...
View ArticleEuropean Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX®...
(Source: AbbVie Inc) - In Phase 3 clinical trials, VIEKIRAX + EXVIERA cured 95-100 percent of genotype 1 chronic hepatitis C patients, with less than 2 percent of patients experiencing virologic...
View ArticleAbbVie to Present Data on VIEKIRAX® (ombitasvir/paritaprevir/ritonavir...
(Source: AbbVie Inc) Mar 30, 2016 NORTH CHICAGO, Ill., March 30, 2016 /PRNewswire / -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that 25 abstracts have been accepted for...
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