BC Extra | Aug 28, 2019
Politics & Policy

Aug. 28 P&P Quick Takes: Liver failure warning for HCV drugs; plus FDA guidances and more

Liver failure linked to HCV drugs  FDA said it has identified 63 incidences of worsening liver function, including cases of liver failure and death, in patients with liver impairment taking HCV drugs Mavyret glecaprevir/pibrentasvir from...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BC Week In Review | Aug 10, 2018
Company News

Zepatier lands co-exclusive status on Express Scripts 2019 formulary

Express Scripts Holding Co. (NASDAQ:ESRX) announced its 2019 National Preferred Formulary Exclusions , noting that the exclusions were driven not only by the size of the rebate as in years past, but also by lower list...
BC Extra | Aug 9, 2018
Politics & Policy

China releases list of overseas drugs eligible for Priority Review

China’s Drug Evaluation Center posted a list of 48 drugs already approved in the U.S., EU or Japan that could be eligible for Priority Review in China. Last December, China's State Drug Administration released guidance...
BC Extra | Aug 7, 2018
Company News

Zepatier lands co-exclusive status on Express Scripts 2019 formulary

Express Scripts Holding Co. (NASDAQ:ESRX) announced its 2019 National Preferred Formulary Exclusions , noting that the exclusions were driven not only by the size of the rebate as in years past, but also by lower list...
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 | Nov 3, 2017
Regulation

Frame work

A little over four years into its implementation, FDA’s structured benefit-risk framework appears to be meeting its objectives of creating transparency into its approval decisions. The agency began to incorporate the framework templates into its...
BioCentury | Oct 6, 2017
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,...
BioCentury | Sep 9, 2017
Strategy

Some of the parts

The acquisition of Kite Pharma Inc. by Gilead Sciences Inc. could put the industry-leading CAR T pipeline in the hands of the company best-suited to expand the cell therapies into the as-yet-elusive solid tumor space....
BC Week In Review | Aug 4, 2017
Clinical News

European Commission approves Gilead’s HCV triple combo

Gilead Sciences Inc. (NASDAQ:GILD) said the European Commission approved Vosevi sofosbuvir/velpatasvir/voxilaprevir to treat HCV genotypes 1-6 infection in adults. The drug is approved as a 12-week regimen for patients without cirrhosis or with compensated cirrhosis...
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