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.
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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.
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.
Daiichi Sankyo Company announced results from a prespecified subgroup analysis of 771 cancer patients enrolled in its Phase 3 Hokusai-VTW study evaluating the use of edoxaban.
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).
Daiichi Sankyo has announced that a New Drug Application (NDA) has been submitted to the FDA for Savaysa (edoxaban) Tablets for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for the prevention of recurrence of symptomatic venous thromboembolism (VTE).
The FDA has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis (apixaban; Bristol-Myers Squibb Company and Pfizer) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE.
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.
Janssen and Bayer announced the results from their real-world study XALIA, showing that the rates of major bleeding and recurrent blood clots for Xarelto (rivaroxaban) in routine clinical practice were generally consistent with Phase 3 data in patients with deep vein thrombosis (DVT), with shorter hospital stays than standard anticoagulation.