A subgroup analysis from the RE-LY trial has demonstrated that in patients with atrial fibrillation (AF), twice-daily dabigatran etexilate has better efficacy and lower rates of major bleeding when compared with warfarin, as reported at ACC.11, the American College of Cardiology’s 60th Annual Scientific Session.
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Upsher-Smith Laboratories is voluntarily expanding its previously announced recall of Jantoven (warfarin sodium) 3mg tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010.
Upsher-Smith Laboratories announced a nationwide voluntary recall of Jantoven (warfarin sodium) 3mg tablets with an expiration date of September 2012, Lot #284081NDC #0832-1214-00.
A prospective phase 2 study of the low-molecular-weight heparin (LMWH) tinzaparin for initial treatment and secondary prophylaxis of venous thromboembolism (VTE) associated with cancer treatment found the agent to be safe and efficacious, with the recurrent VTE event rate comparing favorably with that reported for another LMWH, dalteparin according to a study presented at the 52nd American Society of Hematology Meeting and Exposition.
Patients with newly diagnosed or previously treated multiple myeloma (MM) who receive thalidomide (T)- or lenalidomide (L)-based regimens are at high risk of venous thromboembolism (VTE), and it is uncertain whether thromboprophylaxis provides a clear benefit, especially in those who receive L-based therapy or have previously treated disease, according to results of a systematic review and meta-analysis that were shown at the 52nd American Society of Hematology Meeting and Exposition.
Novel oral anticoagulants, that do not require the laboratory monitoring associated with warfarin therapy, may alter the landscape of venous thromboembolism treatment and stroke prevention in atrial fibrillation, according to a study presented at the 52nd American Society of Hematology Meeting and Exposition.
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.
Boehringer Ingelheim announced that the FDA has approved Pradaxa (dabigatran etexilate capsules), an oral direct thrombin inhibitor, to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).
The FDA has granted Sandoz approval of a generic version of Lovenox (enoxaparin sodium injection, from sanofi aventis).