Bayer Completes Enrollment into Major Phase III Study with Rivaroxaban
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- Category: Bayer
Bayer Schering Pharma has completed patient enrollment into the Phase III ROCKET AF study (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF study is assessing the efficacy and safety of rivaroxaban (Xarelto®) 20 mg once-daily, a novel oral, direct Factor Xa inhibitor, compared to the current standard of care, warfarin, a vitamin K antagonist (VKA) dose-adjusted, for the prevention of stroke and non-CNS systemic embolism in patients with Atrial Fibrillation (AF).
Studies Published in The Lancet Show Roflumilast Improves Lung Function and Reduces Exacerbations
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- Category: Clinical Trials
Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer and Nycomed, a privately owned pharmaceutical company, announced that results of four phase III trials have been published in the prestigious peer-reviewed medical journal The Lancet showing that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced exacerbations in patients with moderate to severe COPD.
Abbott to Collaborate With Pfizer Inc on Companion Diagnostic Test
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- Category: Abbott
Abbott has entered into an agreement with Pfizer Inc to develop a molecular diagnostic test intended to screen non-small cell lung cancer (NSCLC) tumors for the presence of gene rearrangements. Pfizer has developed a novel investigational agent that selectively targets cancer-causing genes implicated in the progress of many cancers.
Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy
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- Category: Amgen
Amgen (Nasdaq: AMGN) announced that in a large, randomized, double-blind, placebo-controlled, Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia and type-2 diabetes (the Trial to Reduce Cardiovascular Endpoints with Aranesp((R)) Therapy, or TREAT), treatment of anemia with Aranesp((R) )(darbepoetin alfa) to a hemoglobin target of 13 g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment.
Health Canada Approves Abbott's XIENCE V(R) Drug Eluting Stent
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- Category: Abbott
Abbott (NYSE: ABT) has received approval from Health Canada for the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease (CAD). XIENCE V is the only drug eluting stent to have demonstrated superiority over the TAXUS Paclitaxel-Eluting Coronary Stent System (TAXUS) in the primary endpoints of two randomized, pivotal (phase III) clinical trials.
Lilly Reports on Outcome of Phase III Study of Arzoxifene
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- Category: Eli Lilly and Company
Eli Lilly and Company (NYSE: LLY) has announced that initial results from its pivotal, five-year, Phase III GJAD "GENERATIONS" trial for arzoxifene failed to demonstrate a statistically significant difference in key secondary efficacy endpoints, such as non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function, compared to placebo.
Novartis drug Femara® is superior to tamoxifen after breast cancer surgery
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- Category: Novartis
Newly published data in The New England Journal of Medicine affirm five-year upfront use of Femara® (letrozole) following surgery as an optimal treatment approach versus tamoxifen for postmenopausal women with early stage breast cancer (hormone-receptor positive).
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