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...
00:38 , Jan 6, 2018 |  BioCentury  |  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...
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...
23:52 , Oct 6, 2017 |  BioCentury  |  Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
21:31 , Sep 29, 2017 |  BC Week In Review  |  Clinical News

China approves HCV drugs from Gilead and AbbVie

Gilead Sciences Inc. (NASDAQ:GILD) said China FDA approved Sovaldi sofosbuvir (GS-7977) 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...
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...
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...
07:00 , Oct 4, 2016 |  BC Extra  |  Company News

FDA adds warning to HCV drugs' labels

On Tuesday, FDA added a boxed warning to the labels of direct-acting antivirals for HCV. The warning describes the risk of reactivation of HBV infection in patients receiving the therapies. The agency said healthcare providers...
07:00 , Oct 3, 2016 |  BC Week In Review  |  Clinical News

Exviera dasabuvir: Phase IIIb data

Top-line data from the open-label, international Phase IIIb GARNET trial in 163 treatment-naive patients with chronic HCV genotype 1b infection without cirrhosis showed that once-daily Viekirax ombitasvir/paritaprevir/ritonavir plus twice-daily Exviera dasabuvir without ribavirin for 8...