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...
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...
07:00 , Aug 3, 2015 |  BC Week In Review  |  Clinical News

Daklinza daclatasvir regulatory update

FDA approved an NDA from Bristol-Myers Squibb for its Daklinza daclatasvir in combination with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD, Foster City, Calif.) to treat HCV genotype 3 infection. On July 24, BMS said...
02:53 , Jul 28, 2015 |  BC Extra  |  Company News

FDA approves Daklinza for HCV genotype 3

FDA approved Daklinza daclatasvir from Bristol-Myers Squibb Co. (NYSE:BMY) in combination with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat HCV genotype 3. BMS spokesperson Robert Perry said BMS expects to launch Daklinza within...
01:13 , Jul 24, 2015 |  BC Extra  |  Company News

BMS beats Street, posts ex-U.S. HCV sales

Bristol-Myers Squibb Co. (NYSE:BMY) reported total revenues of $4.2 billion in 2Q15, including $479 million from ex-U.S. sales of HCV drugs Daklinza daclatasvir and Sunvepra asunaprevir . The overall sales beat the Street's estimate of...
07:00 , Jun 29, 2015 |  BC Week In Review  |  Company News

Bristol-Myers infectious news

Bristol-Myers said it will discontinue drug discovery in virology and cut about 100 jobs as part of an ongoing R&D reorganization announced in 2013. The company said the change will not affect its clinical-stage and...
01:23 , Jun 26, 2015 |  BC Extra  |  Company News

BMS ending virology discovery, building Cambridge hub

Bristol-Myers Squibb Co. (NYSE:BMY) said it will discontinue drug discovery in virology as part of an ongoing R&D reorganization. The company said the change will not affect its clinical-stage and marketed virology products. BMS will...
01:56 , May 21, 2015 |  BC Extra  |  Company News

FDA narrows breakthrough designation for BMS HCV combo

Bristol-Myers Squibb Co. (NYSE:BMY) said a combination of its daclatasvir ( BMS-790052 ) and Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) received an amended breakthrough therapy designation from FDA to treat HCV genotype 1 infection...
07:00 , Apr 13, 2015 |  BioCentury  |  Product Development

HCV race in China

Armed with positive Phase II HCV data, Ascletis Pharmaceuticals Co. Ltd. may be able to leapfrog Gilead Sciences Inc. to market in China even though both companies are now seeking approval to begin Phase III...
07:00 , Apr 6, 2015 |  BioCentury  |  Finance

Up, up and acquired

For the first time since 1Q14, none of the biotech market cap segments fell. While the $200-$499 million tier treaded water, all other segments finished in the black, led by the $1-$4.9 billion segment. Large...