22:52 , Apr 26, 2019 |  BC Extra  |  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...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
17:36 , Mar 8, 2019 |  BC Week In Review  |  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...
22:10 , Mar 1, 2019 |  BC Extra  |  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...
02:49 , Jan 5, 2019 |  BioCentury  |  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...
01:48 , Jan 4, 2019 |  BC Week In Review  |  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...
21:09 , Dec 31, 2018 |  BC Extra  |  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...
22:55 , Sep 7, 2018 |  BC Extra  |  Company News

Amid launch troubles, Portola commercial chief Fu resigns

With its stock price near its 52-week low amid a disappointing launch of anticoagulant Bevyxxa betrixaban, Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said EVP and Chief Commercial and Business Officer Tao Fu is resigning to pursue other...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with...
17:51 , May 11, 2018 |  BC Week In Review  |  Clinical News

FDA approves Portola's Andexxa

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) added about $570 million in market cap on May 4 after FDA granted accelerated approval to a resubmitted BLA for its Andexxa andexanet alfa. The agency approved Andexxa to reverse the...