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.
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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).
GenMark Diagnostics announced that it has received clearance from the FDA for its eSensor Respiratory Virus Panel (RVP) for use on its XT-8 system, intended to simultaneously detect and differentiate 14 clinically relevant viruses from patients with influenza-like illness.
Boehringer Ingelheim announced that the Pradaxa (dabigatran etexilate mesylate capsules) prescribing information has been updated to affirm that Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin
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).
The FDA has notified healthcare professionals that it is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim).