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 the effect of anticoagulant drugs Eliquis apixaban or Xarelto rivaroxaban in adults with life-threatening or uncontrolled bleeding.
Ondexxya is a modified human Factor Xa protein that acts as a decoy to target and sequester Factor Xa inhibitors. Portola gained $1.02 to $37.01 Friday...
BCIQ Company Profiles