21:54 , Sep 25, 2017 |  BC Extra  |  Company News

Gilead's Sovaldi gets Chinese approval

Gilead Sciences Inc. (NASDAQ:GILD) said China FDA approved Sovaldi sofosbuvir to treat HCV genotypes 1-6 infection as part of an antiviral treatment regimen in patients ages 12 and older. Gilead said the nucleotide analog HCV...
22:19 , Aug 3, 2017 |  BC Extra  |  Company News

FDA approves AbbVie’s Mavyret for HCV

FDA approved Mavyret glecaprevir/pibrentasvir from AbbVie Inc. (NYSE:ABBV) to treat chronic HCV genotypes 1-6 infection in previously untreated adults without cirrhosis or with compensated cirrhosis. The fixed-dose combination is also indicated for HCV genotype 1...
18:56 , Jun 30, 2017 |  BC Week In Review  |  Clinical News

CHMP recommends Gilead’s sofosbuvir/velpatasvir/voxilaprevir combo for HCV infection

EMA’s CHMP recommended approval of an MAA from Gilead Sciences Inc. (NASDAQ:GILD) for Vosevi sofosbuvir/velpatasvir/voxilaprevir to treat chronic HCV infection. Gilead said the data included in the application support the use of Vosevi in patients...
16:05 , May 4, 2017 |  BC Week In Review  |  Clinical News

China approves Daklinza/Sunvepra combo for HCV

Bristol-Myers Squibb Co. (NYSE:BMY) said China FDA approved Daklinza daclatasvir (BMS-790052) in combination with Sunvepra asunaprevir to treat HCV genotype 1b infection in patients with or without cirrhosis. The company said it is CFDA's first...
22:24 , Apr 28, 2017 |  BC Extra  |  Company News

China FDA approves Daklinza combos for HCV

Bristol-Myers Squibb Co. (NYSE:BMY) said China FDA approved Daklinza daclatasvir in combination with Sunvepra asunaprevir to treat HCV genotype 1b in patients with or without cirrhosis. The company said it is CFDA's first approval of...
08:00 , Feb 29, 2016 |  BC Week In Review  |  Clinical News

Sunvepra asunaprevir: Phase III data

Top-line data from an open-label, Asian Phase III trial in 159 patients with chronic HCV genotype 1b infection who were intolerant or ineligible for interferon (IFN) therapies showed that once-daily 60 mg oral Daklinza daclatasvir...
08:00 , Feb 29, 2016 |  BC Week In Review  |  Clinical News

Daklinza daclatasvir: Phase III data

Top-line data from an open-label, Asian Phase III trial in 159 patients with chronic HCV genotype 1b infection who were intolerant or ineligible for interferon (IFN) therapies showed that once-daily 60 mg oral Daklinza daclatasvir...
02:39 , Feb 23, 2016 |  BC Extra  |  Clinical News

BMS's oral HCV combo under review in China

Bristol-Myers Squibb Co. (NYSE:BMY) presented data from an open-label Phase III trial evaluating a combination of its HCV drugs Daklinza daclatasvir plus Sunvepra asunaprevir in non-Japanese Asian patients with chronic HCV genotype 1b, and disclosed...
08:00 , Jan 7, 2016 |  BC Innovations  |  Distillery Therapeutics

Therapeutics: HCV NS5A protein

Infectious disease INDICATION: Hepatitis C virus (HCV) In vitro studies suggest combining inhibitors of HCV NS5A protein could help treat Daklinza daclatasvir-resistant HCV infection. Screening of HCV NS5A inhibitors in a human cell-based HCV replication...
08:00 , Nov 2, 2015 |  BC Week In Review  |  Clinical News

Daklinza daclatasvir: Phase II data

The open-label, Chinese Phase II SODAPI trial in 26 non-cirrhotic patients with chronic HCV genotype 1b infection showed that Harvoni ledipasvir/sofosbuvir plus Sunvepra asunaprevir (Group 1, n=12), Sovaldi sofosbuvir plus Daklinza daclatasvir and Olysio simeprevir...