Bristol-Myers Squibb and Pfizer announced results from a six month Phase 3 AMPLIFY trial in patients with acute venous thromboembolism who received Eliquis (apixaban) or the current standard of care, parenteral enoxaparin treatment overlapped by warfarin therapy.
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Bristol-Myers Squibb and Pfizer announced that the reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis (apixaban) compared to warfarin (Coumadin; Bristol-Myers Squibb) in the Phase 3 ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation; these were results from a subanalysis from the study.
Bristol-Myers Squibb and Pfizer announced that the FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
CSL Behring announced that the FDA has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (eg, warfarin) in patients with acute major bleeding.
CSL Behring announced results of a Phase 3b study that showed that a balanced, human 4-factor prothrombin complex concentrate (PCC) is as effective as the current standard of treatment in stopping bleeding in patients receiving vitamin K antagonist therapy (eg, warfarin).
Bristol-Myers Squibb and Pfizer announced the results from its Phase 3 ARISTOTLE trial evaluating Eliquis (apixaban) for the prevention of stroke or systemic embolism in patients with atrial fibrillation and at least one risk factor for stroke compared to warfarin.
Bristol-Myers Squib and Pfizer announced results from their Phase 3 ARISTOTLE study of Eliquis (apixaban tablet) in patients with atrial fibrillation (AF) and at least one additional risk factor for stroke.
Daiichi Sankyo announced that it has completed patient enrollment for its Phase 3 study of edoxaban, to prevent the occurrence of strokes and systemic embolic events (SEE) in patients with atrial fibrillation (AF).
Johnson & Johnson Pharmaceutical Research & Development announced results from its Phase 3 study of rivaroxaban in non-valvular atrial fibrillation (AF) patients to reduce the risk of stroke and non-CNS systemic embolism.