Anticoagulant News and Research

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FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

European Commission approves Boehringer Ingelheim's Pradaxa for prevention of DVT and PE

Boehringer Ingelheim today announces that Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE).

6 Jun 2014

Registration now open for interactive one day workshop for GPs

Registration is now open for an interactive one day workshop in Brisbane, designed by GPs for GPs, that will cover five hot topics — including statin prescribing and whether the hype is justified on newer oral anticoagulants.

19 May 2014

Anticoagulation therapy with low-dose aspirin can be used with new generation mechanical heart valve

Less aggressive anticoagulation therapy, combined with low-dose aspirin, can be used safely in conjunction with a newer generation mechanical heart valve.

16 May 2014

AFib patients who are on blood thinning medications are at higher risk of developing dementia

A new study by researchers at the Intermountain Medical Center Heart Institute in Salt Lake City has found that atrial fibrillation patients who are on blood thinning medications are at higher risk of developing dementia if their doses are not in the optimal recommended range.

12 May 2014

Ambrisentan cleared for use with phenprocoumon

Starting treatment with ambrisentan does not necessitate adjusting the dose of the oral anticoagulant phenprocoumon in patients with pulmonary hypertension who require both medications, report researchers.

7 May 2014

AstraZeneca’s EPANOVA receives FDA approval for treatment of adults with hypertriglyceridemia

AstraZeneca today announced the US Food and Drug Administration (FDA) approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

7 May 2014

Teva's SYNRIBO for injection receives FDA approval for home administration

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved SYNRIBO® (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use.

6 May 2014

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) providing regular approval for Soliris® (eculizumab) for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

6 May 2014

Armetheon reaches agreement with FDA on SPA for final pivotal trial of tecarfarin

Armetheon, Inc., today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the final pivotal trial of tecarfarin.

29 Apr 2014

Biomedical engineer develops highly innovative technology to make blood transfusions safer

A biomedical engineer at the University of Houston (UH) is working to develop highly innovative technology to make blood transfusions safer. His work is supported by a $1.8 million grant from the National Institutes of Health (NIH).

25 Apr 2014

Alexion Pharmaceuticals obtains orphan drug designation from EC for Soliris

Alexion Pharmaceuticals, Inc. today announced that the European Commission has granted an orphan drug designation (ODD) to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of graft rejection following solid organ transplantation. Graft rejection can cause severe injury to the transplanted organ and is a significant barrier to successful transplantation.

23 Apr 2014

Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Johnson & Johnson today announced sales of $18.1 billion for the first quarter of 2014, an increase of 3.5% as compared to the first quarter of 2013. Operational results increased 5.3% and the negative impact of currency was 1.8%. Domestic sales increased 2.2%. International sales increased 4.5%, reflecting operational growth of 7.9% and a negative currency impact of 3.4%.

15 Apr 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc.

8 Apr 2014

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).

8 Apr 2014

Perioperative aspirin increases risk of serious bleeding after non-heart-related surgery

Patients given aspirin to prevent heart problems after non-heart-related surgery had a higher risk of serious bleeding than the patients who did not receive aspirin.

1 Apr 2014

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy.

31 Mar 2014

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).

31 Mar 2014

Poor blood pressure control increases stroke risk in patients with atrial fibrillation

Poor blood pressure control among patients with atrial fibrillation is associated with a 50-percent increased risk of stroke, according to an analysis presented by Duke Medicine researchers.

31 Mar 2014

Genetic testing could help determine drug dosage, reduce side effects

Usually pharmaceutical companies determine the drug dosage just as a mean value. This amount may be too much for patients who absorb the substance faster, and too little for those with a slower metabolism.

27 Mar 2014

Anticoagulant News and Research

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

European Commission approves Boehringer Ingelheim's Pradaxa for prevention of DVT and PE

Registration now open for interactive one day workshop for GPs

Anticoagulation therapy with low-dose aspirin can be used with new generation mechanical heart valve

AFib patients who are on blood thinning medications are at higher risk of developing dementia

Ambrisentan cleared for use with phenprocoumon

AstraZeneca’s EPANOVA receives FDA approval for treatment of adults with hypertriglyceridemia

Teva's SYNRIBO for injection receives FDA approval for home administration

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

Armetheon reaches agreement with FDA on SPA for final pivotal trial of tecarfarin

Biomedical engineer develops highly innovative technology to make blood transfusions safer

Alexion Pharmaceuticals obtains orphan drug designation from EC for Soliris

Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

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

Perioperative aspirin increases risk of serious bleeding after non-heart-related surgery

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

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

Poor blood pressure control increases stroke risk in patients with atrial fibrillation

Genetic testing could help determine drug dosage, reduce side effects

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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