19:28 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Gilead's Epclusa approved in China for HCV

Gilead Sciences Inc. (NASDAQ:GILD) said China's State Drug Administration (formerly China FDA) approved Epclusa sofosbuvir/velpatasvir to treat adults with chronic HCV genotypes 1-6. The agency also approved Epclusa plus ribavirin to treat adults with HCV...
16:11 , May 30, 2018 |  BC Extra  |  Company News

Gilead's Epclusa approved in China for HCV

Gilead Sciences Inc. (NASDAQ:GILD) said China's State Drug Administration (formerly China FDA) approved Epclusa sofosbuvir/velpatasvir to treat adults with chronic HCV genotypes 1-6. The agency also approved Epclusa plus ribavirin to treat adults with HCV...
01:27 , Dec 2, 2017 |  BioCentury  |  Strategy

Opening the gates in China

A flurry of approvals of HCV drugs in China this year illustrates how the country’s regulatory reforms have leveled the playing field for multinational drug sponsors, who had been disadvantaged compared with domestic companies. As...
21:43 , Oct 27, 2017 |  BC Week In Review  |  Company News

Arcturus, JNJ to develop nucleic acids to treat HBV

Arcturus Therapeutics Inc. (San Diego, Calif.) and the Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) partnered to develop and commercialize nucleic acid-based compounds to treat HBV. The companies will use Arcturus' unlocked nucleomonomer...
21:09 , Sep 15, 2017 |  BC Week In Review  |  Company News

J&J drops Achillion HCV deal

Johnson & Johnson (NYSE:JNJ) terminated a 2015 deal with Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) to develop and commercialize HCV therapies, including triplet therapy JNJ-4178 . J&J said it decided to discontinue development of JNJ-4178 “in light...
00:12 , Sep 12, 2017 |  BC Extra  |  Company News

Achillion down after J&J drops HCV compound

Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) lost $1.08 (22%) to $3.83 Monday after Johnson & Johnson (NYSE:JNJ) terminated a 2015 deal to develop and commercialize HCV therapies, including triplet therapy JNJ-4178 . J&J said it decided to...
23:55 , Apr 28, 2017 |  BioCentury  |  Politics, Policy & Law

Access and innovation in Japan

Regulatory reforms have paved the way for innovative therapies to launch in Japan before anywhere else in the world. This should result in earlier access to more innovative medicines than ever before - but only...
00:52 , Jan 11, 2017 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Hepatitis C virus (HCV) Cell culture studies identified cajanine and its analogs as CSGALNACT1 inhibitors that could treat HCV infection. A human hepatoma cell line-based mRNA assay identified cajanine as an inhibitor of CSGALNACT1....
01:42 , Dec 30, 2016 |  BC Week In Review  |  Clinical News

JNJ-4178: Ph IIb OMEGA-1 started

Achillion said Johnson & Johnson began the open-label, international Phase IIb OMEGA-1 trial to evaluate oral JNJ-4178 once daily for 6 or 8 weeks in about 300 patients without cirrhosis. JNJ-4178 comprises 800 mg AL-335...
23:15 , Dec 15, 2016 |  BC Week In Review  |  Clinical News

Direct-acting antivirals regulatory update

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) completed a safety review confirming that patients treated with direct-acting antivirals (DAAs) to treat HCV infection may be at risk for HBV reactivation. The committee recommended screening for HBV...