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Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE). [More]

Enrollment commences for Daiichi Sankyo's ENSURE-AF multinational phase 3 study in NVAF patients

Daiichi Sankyo Company, Limited today announced that it has started enrolling patients into the ENSURE-AF multinational phase 3 study, which will evaluate the efficacy and safety of its investigational oral, once-daily direct factor Xa-inhibitor edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm). [More]

ISTH declares Oct.13 as World Thrombosis Day

Bringing together nations and local communities to tackle thrombosis, the quiet, underlying disorder that is the common mechanism of the world's three top cardiovascular killers – heart attack, stroke and venous thromboembolism (VTE) – the International Society on Thrombosis and Haemostasis (ISTH) today announced that October 13 will be designated World Thrombosis Day, with the inaugural event to be held this year. [More]

ATS develops clinical practice guidelines to help clinicians identify, manage patients with sickle cell disease

The American Thoracic Society has developed clinical practice guidelines to help clinicians identify and manage patients with sickle cell disease who are at increased risk for mortality from pulmonary hypertension. [More]

FDA accepts Regado Biosciences' IND application for REG2

Regado Biosciences, Inc., a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced that the United States Food and Drug Administration has accepted the company's investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose Phase 1 clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future. [More]

Daiichi Sankyo submits Marketing Authorization Application for edoxaban to EMA

Daiichi Sankyo, Company Limited (hereafter, Daiichi Sankyo) today announced that the Marketing Authorization Application for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban has been submitted to the European Medicines Agency. [More]

Daiichi Sankyo submits LIXIANA supplemental NDA for review in Japan

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application for its oral, once-daily direct factor Xa-inhibitor LIXIANA® (Edoxaban Tosilate Hydrate) for review by the Japanese Ministry of Health, Labour and Welfare. Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation and symptomatic venous thromboembolism. [More]
Late-breaking abstracts on treatment of blood cancers and bleeding disorders presented at ASH meeting

Late-breaking abstracts on treatment of blood cancers and bleeding disorders presented at ASH meeting

A range of studies highlighting late-breaking research advances in the understanding and treatment of blood cancers and bleeding disorders are being presented today during the 55th American Society of Hematology Annual Meeting and Exposition in New Orleans. [More]
Findings may help clinicians determine which hospitalized children at greatest risk of VTE

Findings may help clinicians determine which hospitalized children at greatest risk of VTE

Life-threatening blood clots occur so rarely in children that the condition, known as venous thromboembolism (VTE), is often not on pediatricians' mental radar screens - an absence that can lead to woefully delayed recognition and treatment. [More]
Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La. [More]
Daiichi Sankyo presents subgroup analysis of Hokusai-VTE study at ASH annual meeting

Daiichi Sankyo presents subgroup analysis of Hokusai-VTE study at ASH annual meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced results of a prespecified subgroup analysis of 771 cancer patients enrolled in the phase 3 Hokusai-VTE study. [More]
French National Expert Committee on Maternal Mortality formulates twenty recommendations

French National Expert Committee on Maternal Mortality formulates twenty recommendations

Twenty recommendations have been formulated by the French National Expert Committee on Maternal Mortality with the aim of raising awareness among health professionals and prospective parents, in consultation with the French National College of Obstetricians and Gynaecologists and the French Society of Anaesthetists/Obstetric Anaesthesia Club. [More]
Phase III EINSTEIN trial program: XARELTO reduces risk of DVT and PE

Phase III EINSTEIN trial program: XARELTO reduces risk of DVT and PE

Janssen Pharmaceuticals, Inc. announced today a newly published, pooled analysis of the Phase III EINSTEIN trial program, showing XARELTO (rivaroxaban) is as effective as the standard of care in reducing the risk of deep vein thrombosis and pulmonary embolism in people with symptomatic DVT or PE, while reducing the incidence of major bleeding by 46 percent. [More]

Hokusai-VTE findings provide fresh insight into patients with pulmonary embolism

In the treatment of venous thromboembolism (VTE), the oral anticoagulant edoxaban resulted in equal efficacy and better safety compared to standard warfarin when either drug was used with initial low molecular weight heparin (LMWH), according to the results of the Hokusai-VTE trial. [More]
Multiple risk factors eliminate impact of AF on stroke risk, but more research is needed

Multiple risk factors eliminate impact of AF on stroke risk, but more research is needed

Dr Benn Christiansen said: "We know that atrial fibrillation increases the risk of ischemic stroke. And in patients with atrial fibrillation or previous ischemic stroke, the risk of stroke increases with the number of risk factors. [More]

"Risk calculator" enables doctors to estimate risk of venous thrombosis

In Austria, around 15,000 people a year develop a venous thrombosis, the occlusion of a vein that can result in a pulmonary embolism. A clot breaks free from a vein and travels via the bloodstream to the lungs, where it blocks vessels. [More]
August edition of NPS RADAR includes reviews for new medicines listed on PBS

August edition of NPS RADAR includes reviews for new medicines listed on PBS

The 10th anniversary edition of NPS RADAR contains reviews for new medicines listed on the Pharmaceutical Benefits Scheme including rivaroxaban (Xarelto), rotigotine patches (Neupro) and mifepristone (Mifepristone Linepharma) followed by misoprostol (GyMiso). [More]
ACC report helps clinicians optimize appropriate use of noninvasive vascular tests

ACC report helps clinicians optimize appropriate use of noninvasive vascular tests

A new report issued today by the American College of Cardiology (ACC) and developed in collaboration with 10 other leading professional societies provides detailed criteria to help clinicians optimize the appropriate use of certain noninvasive vascular tests when caring for patients with known or suspected disorders of the venous (veins) system. [More]
Celgene to discontinue treatment with REVLIMID in phase III ORIGIN trial

Celgene to discontinue treatment with REVLIMID in phase III ORIGIN trial

Celgene Corporation today announced that after consultation with the U.S. Food and Drug Administration Celgene will discontinue treatment with REVLIMID (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries. [More]
Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival. [More]