BC Extra | Jan 2, 2020
Politics & Policy

Drug price hikes would have been impossible under pending bipartisan legislation backed by White House, Democrats

The latest round of increases in the list prices of drugs highlights how pending bipartisan legislation could force biopharma companies to rethink their business models. In what has become a predictable biannual event, manufacturers announced...
BioCentury | Dec 21, 2019
Politics, Policy & Law

U.S. drug industry hopes China deal ends stealth attack on IP

Innovator pharmaceutical manufacturers hope the new “phase one” U.S.-China trade deal will create a cease-fire in the stealth war on pharma IP in China. The deal, announced Dec. 13, comes at the end of a...
BioCentury | Oct 9, 2019
Politics, Policy & Law

Time to fulfill China’s promise of IP reform

Two years ago, on Oct. 8, 2017, the top bodies of the Chinese Communist Party and the Chinese government created a pathway to IP reform that promised to propel the nation into the global innovation...
BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BC Extra | Apr 26, 2019
Company News

European regulatory roundup: CHMP opinions and a Portola approval

EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies. Also Friday, the European Commission granted conditional approval to Ondexxya andexanet alfa from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to reverse...
BC Week In Review | Mar 8, 2019
Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions on March 1, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first...
BC Extra | Mar 1, 2019
Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions Friday, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first approved antidote...
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 | Jan 4, 2019
Clinical News

Portola gains next-generation Andexxa approval, aims for wider U.S. launch

FDA approved a Prior Approval Supplement for Andexxa recombinant coagulation factor Xa inactivated-zhzo (formerly andexanet alfa) to be manufactured with a second generation process, which Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said will support a broader launch...
BC Extra | Dec 31, 2018
Company News

Portola gains next-generation Andexxa approval, aims for wider U.S. launch

FDA approved a Prior Approval Supplement for Andexxa recombinant coagulation factor Xa inactivated-zhzo (formerly andexanet alfa) to be manufactured with a second generation process, which Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said will support a broader launch...
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