Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union (Merck & Co Inc)

Edit Public Technologies 27 May 2016
(Source ... In the United States, ZEPATIER is indicated for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin (RBV) ... ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotype 1 or 4 infection in adults ... Inc....

News and press releases: Two new combination therapies against chronic hepatitis C (EMA - European Medicines Agency)

Edit Public Technologies 27 May 2016
(Source. EMA - European Medicines Agency). 27/05/2016. Direct-acting antivirals Epclusa and Zepatier recommended for approval ... HCV infection is a major European public health challenge ... The safety and efficacyof Epclusa was tested in clinical trialsinvolving over 2,000 patients, to assess that the HCV was no longer detected in the blood 12 weeks after the end of treatment (sustained virologic response or SVR), with or without ribavirin....

European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C (Gilead Sciences Inc)

Edit Public Technologies 27 May 2016
(Source. Gilead Sciences Inc). --Epclusa is Gilead's Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection-- ... The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of Epclusa with or without ribavirin (RBV) or 24 weeks of Epclusa ... About Gilead ... Forward-Looking Statement ... Source ... Investors ... or ... or....

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2016 (Enanta Pharmaceuticals Inc)

Edit Public Technologies 09 May 2016
(Source. Enanta Pharmaceuticals Inc). Conference Call and Webcast Today at 4.30 p.m ... FDA had approved AbbVie's supplemental New Drug Application for use of VIEKIRA PAK® without ribavirin in genotype 1b chronic hepatitis C patients with compensated cirrhosis (Child Pugh-A), which followed earlier approval in the European Union of AbbVie's VIEKIRAX® + EXVIERA® for similar genotype 1b patients ... Conference Call and Webcast Information ... or....

Merck Announces First-Quarter 2016 Financial Results (Merck & Co Inc)

Edit Public Technologies 05 May 2016
(Source. Merck & Co Inc). KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE.MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2016 ... Sales $9,312 $9,425 ... The FDA approved ZEPATIER (elbasvir and grazoprevir), a once-daily, fixed-dose combination tablet for the treatment of adult patients with chronic hepatitis C virus genotype (GT) 1 or GT4 infection, with or without ribavirin....

Merck Announces First-Quarter 2016 Financial Results

Edit Stockhouse 05 May 2016
Merck (NYSE.MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2016. This Smart News Release features multimedia. View the full release here ...   ... The FDA approved ZEPATIER (elbasvir and grazoprevir), a once-daily, fixed-dose combination tablet for the treatment of adult patients with chronic hepatitis C virus genotype (GT) 1 or GT4 infection, with or without ribavirin....

Hepatitis Awareness Month (Health Services Research & Development)

Edit Public Technologies 02 May 2016
(Source. Health Services Research & Development). May 2016. May is National Hepatitis Awareness Month ... Until recently, HCV treatment was based on therapy with interferon and ribavirin, which required weekly injections for 48 weeks ... While new prescriptions favored boceprevir or telaprevir over standard interferon plus ribavirin therapy, there appeared to still be a strong role for interferon plus ribavirin in treating HCV patients ... (noodl....

Will we take the opportunity to wipe out liver cancer?

Edit Deseret News 29 Apr 2016
Last week, the American College of Physicians (ACP), a group representing 143,000 internal medicine doctors, joined the chorus of politicians, payers and patients decrying rising pharmaceutical costs ... The good news extended to all groups — men, women and children. Death rates for nearly all common cancers declined ... Until recently, the standard therapy for HCV was 48 weeks of Interferon injections and Ribavirin pills ... Dr ... ....

Bristol-Myers Squibb Reports First Quarter Financial Results (Bristol-Myers Squibb Company)

Edit Public Technologies 28 Apr 2016
2016 ... Daklinza In February, the FDA approved Daklinza, an NS5A replication complex inhibitor, in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3 ... The expanded label allows for the use of Daklinza in combination with sofosbuvir (with or without ribavirin, depending on the indication and HCV genotype) in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV....

AbbVie Reports First-Quarter 2016 Financial Results (AbbVie Inc)

Edit Public Technologies 28 Apr 2016
(Source. AbbVie Inc). NORTH CHICAGO, Ill., April 28, 2016 /PRNewswire/ -- AbbVie (NYSE.ABBV) announced financial results for the first quarter ended March 31, 2016 ... Strong U.S ... and internationally ... AbbVie presented new data from its investigational chronic hepatitis C virus (HCV) infection development program for ABT-493 and ABT-530, a once-daily, ribavirin (RBV)-free, pan-genotypic regimen at The International Liver Congress™ (EASL) ... U.S....

BRIEF-Abbvie receives U.S. FDA approval of supplemental new drug application for Viekira Pak without Ribavirin

Edit Reuters 25 Apr 2016
* Abbvie receives u.s. Fda approval of supplemental new drug application for viekira pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin in genotype 1b chronic hepatitis c patients with compensated cirrhosis ....

Enanta Announces U.S. FDA has Approved AbbVie’s Supplemental New Drug Application for Use of VIEKIRA PAK® without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis (Enanta Pharmaceuticals Inc)

Edit Public Technologies 25 Apr 2016
Food and Drug Administration (FDA) has approved AbbVie's supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A) ... For VIEKIRA PAK used without ribavirin, side effects include nausea, itching, and sleep problems....

Enanta Announces U.S. FDA has Approved AbbVie’s Supplemental New Drug Application for Use of VIEKIRA ...

Edit Business Wire 25 Apr 2016
Food and Drug Administration (FDA) has approved AbbVie’s supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b ... ....
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