BC Week In Review | Jun 1, 2018
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...
BC Extra | May 30, 2018
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...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BioCentury | Dec 2, 2017
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...
BC Extra | Sep 25, 2017
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...
BioCentury | Jul 7, 2017
Finance

Onward and upward

The top three market cap tiers continued to outperform smaller caps in 2Q17, led by companies valued between $1 billion and $9.9 billion. Companies valued below $1 billion failed to carry over their momentum from...
BC Week In Review | May 4, 2017
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...
BioCentury | Apr 28, 2017
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 if...
BC Extra | Apr 28, 2017
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...
BC Extra | Apr 26, 2016
Politics & Policy

CFDA names HCV drugs in expedited pathway

China FDA said HCV treatments from seven domestic and multinational companies have been selected for expedited review via a new pathway, L.E.K. Consulting's Helen Chen told BioCentury. The therapies include ravidasvir ( ASC16 ) from Ascletis Pharmaceuticals...
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