Keyword: Portola Pharmaceuticals
Portola has won FDA approval of Andexxa, its antidote for some next-gen bloodthinners, but a manufacturing upgrade will limit initial supplies.
The FDA has again delayed consideration of AndexXa, a bleeding antidote for anticoagulants from Pfizer and Bristol-Myers, as well as Bayer and J&J.
Thanks to an FDA nod, Portola can finally go full throttle on its Bevyxxa launch with an inventory that had been on hold.
With another win, Bayer and Johnson & Johnson are now three for three in fending off lawsuits over the bleeding risks of blockbuster Xarelto.
Halfway into 2017, the FDA has beaten last year's drug-approvals tally with a crop featuring controversy, sales firepower and one very high price.
The FDA has approved Portola Pharmaceuticals’ factor Xa inhibitor Bevyxxa, but now the company is facing plenty of challenges as it gets the drug off the ground.
South San Francisco-based Portola Pharmaceuticals has snagged $50 million in loans from Pfizer and Bristol-Myers Squibb to help cover the additional costs tied to a CRL for its anticoagulant reversal agent.
Tuesday, Portola unveiled some solid data for its next-gen anticoagulant reversal agent that may help soften the blow of a recent FDA rejection.
Boehringer's Pradaxa won an edge on its new-age anticoagulant rivals last year when the FDA approved a reversal agent. It'll hang onto that edge, at least for now.
Portola has gotten an FDA CRL largely focused on manufacturing issues for AndexXa, its breakthrough anticoagulant reversal agent. It joins a number of other companies that this year also received manufacturing-related CRLs.