Tag:
Xarelto
Latest Headlines
Latest Headlines
FDA panel draws blood in Xarelto's bid for new use
After a spirited debate over some missing study data, the advisory committee refused to back a big new use for the blood thinner. Between absent data on about 1,000 patients who withdrew from the trial and worries about its bleeding risks, Xarelto's bid for an expanded market went down.
J&J loses key FDA panel vote on Xarelto
The balloting turned against J&J after 6 of 10 outside experts concluded that the risk of bleeding and doubts about its pivotal data prevented them from endorsing an approval for preventing heart attacks and strokes among patients with heart problems.
FDA staff backs J&J's Xarelto for heart condition
The staffers' recommendation of approval comes ahead of Wednesday's advisory committee meeting on the expanded use of J&J and Bayer's Xarelto in ACS patients.
FDA review backs Xarelto for big new use in ACS patients
The anticoagulant won a thumbs-up from FDA reviewers ahead of Wednesday's advisory panel meeting, where FDA experts will weigh a lucrative new indication.
Bayer gets positive ruling from NICE on Xarelto
NICE has recommended the drug for stroke and embolisms in draft guidance, and final guidance may come in April.
Bayer eyes 16% pharma growth on new meds
Bayer CEO Marijn Dekkers is touting Xarelto 's multibillion-dollar prospects again. This time, though, it's just one of four prospective blockbusters drawing Dekkers' praise.
Pfizer, BMS face a delay on FDA's megablockbuster decision on apixaban
Pfizer ( $PFE ) and its partner Bristol-Myers Squibb ( $BMY ) will have to wait before hearing whether the FDA will sign off on marketing approval for apixaban, their blockbuster anti-clotting hopeful.
Pradaxa, Xarelto gain reprieve as FDA delays Eliquis decision
Pfizer ( $PFE ) and Bristol-Myers Squibb ( $BMY ) will have to wait three more months for the FDA's latest word on Eliquis . The anticoagulant drug has some of the strongest data among a new cadre of...
Bayer CEO Dekkers says price cuts threaten R&D
Bayer CEO Marijn Dekkers totted up a $2.7 billion price tag to research and develop the new anticoagulant Xarelto . And he's warning tight-fisted payers that the more they squeeze drug companies...
FDA puts Xarelto's ACS indication on fast track
The FDA has opened up the fast lane for Bayer and Johnson & Johnson's ( $JNJ ) new blood thinner Xarelto .
