Keyword: Portola Pharmaceuticals
Thursday, February 7, 2019
Lonza and Portola are hard at work; the FDA goes after a compounder; and an Indian biotech opts for continuous manufacturing.
After more than a two-year delay, Portola will see the commercial release of Andexxa, a bleeding antidote for anticoagulants Xarelto and Eliquis.
Portola has hired a 30-year pharma veteran to oversee its manufacturing after running into production delays for its blood thinner antidote.
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.