BC Extra | Jul 8, 2019
Clinical News

July 8 Clinical Quick Takes: Hemophilia data from Sangamo-Pfizer, Novo; plus GamaMabs, Xarelto and more

Sustained Factor VIII levels for Sangamo, Pfizer hemophilia A gene therapy  Sangamo Therapeutics Inc. (NASDAQ:SGMO) and partner Pfizer Inc. (NYSE:PFE) presented data at the International Society on Thrombosis and Haemostasis (ISTH) meeting in Melbourne showing...
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...
BioCentury | Apr 6, 2019
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...
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...
BC Extra | Feb 7, 2019
Politics & Policy

J&J to include drug pricing in TV ads

Johnson & Johnson (NYSE:JNJ) this quarter will begin including the list price and potential out-of-pocket costs of its drugs in its television commercials, starting with anticoagulant Xarelto rivaroxaban. The company made the announcement in a...
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...
BC Extra | Sep 7, 2018
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...
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