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...
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...
23:47 , Feb 7, 2019 |  BC Extra  |  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...
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...
18:51 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

J&J's Xarelto misses in pair of Phase III trials in acute medically ill and heart failure patients

Johnson & Johnson (NYSE:JNJ) reported that anticoagulant Xarelto rivaroxaban missed the primary endpoints in both the Phase III MARINER and COMMANDER HF trials. Data were presented at the European Society of Cardiology meeting in Munich...
21:38 , Jun 7, 2018 |  BC Extra  |  Politics & Policy

CDER to resolve formal disputes at the center level

FDA Center for Drug Evaluation and Research Director Janet Woodcock said the Office of Executive Programs will now manage CDER's formal dispute resolution (FDR) program. The process allows sponsors of user fee drug and generics...