Thrombosis News and Research

Latest Thrombosis News and Research

Researchers develop new animal model for studying hemophilia A

Researchers at Yale School of Medicine have developed a new animal model for studying hemophilia A, with the goal of eventually treating people with the disorder.

3 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Iroko Cardio International Sàrl announces data on HDB dosing of tirofiban, abciximab in interventional cardiology

Iroko Cardio International Sàrl announces long-term, three-year, mortality data from the Phase III, open label, multi-national study comparing high-dose bolus (HDB) dosing of AGGRASTAT(tirofiban) (25mcg/kg bolus followed by a 0.15mcg/kg/min infusion for 18-24 hours) vs. ReoPro (abciximab) in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), presented at the 2010 European Society of Cardiology Meeting in Stockholm, Sweden.

3 Sep 2010

XARELTO achieves net clinical benefit in treatment of patients with DVT

Bayer HealthCare Pharmaceuticals today announced that XARELTO (rivaroxaban), a novel anti-clotting therapy, achieved improvement in net clinical benefit in a study looking at treatment of patients with deep vein thrombosis. DVT is the formation of a blood clot in a deep vein, usually in the legs, that partially or totally blocks the flow of blood.

2 Sep 2010

InfraReDx receives 510(k) clearance to market LipiScan IVUS Coronary Imaging System

InfraReDx, Inc., a medical device company developing intelligent cardiovascular diagnostic imaging technologies, today announced that it has received 510(k) clearance from the United States Food and Drug Administration to market the LipiScan IVUS Coronary Imaging System. LipiScan IVUS is the first cardiac catheter to combine intravascular ultrasound and near-infrared spectroscopy to help cardiologists identify and characterize the plaques that complicate stenting and are associated with acute coronary events.

2 Sep 2010

ESC releases new Clinical Practice Guidelines for management of Grown-up Congenital Heart Disease

The European Society of Cardiology (ESC) today announces the release of new Clinical Practice Guidelines covering the management of Grown-up Congenital Heart Disease (GUCH). More than two million adults in Europe are assumed to be affected by the condition, and the numbers are growing as a consequence of sharply increased survival rates due to advances in paediatric cardiology and heart surgery.

2 Sep 2010

Standard dose of UFH optimal for treatment of PCI patients on fondaparinux: Study

A landmark international study, coordinated by McMaster University, has found that lower doses of a blood thinner called unfractionated heparin (UFH) during angioplasty did not reduce bleeding or vascular complications compared to standard dose UFH in patients initially treated with a blood thinner, fondaparinux.

31 Aug 2010

CORDIS reports positive results from 10-year follow-up of CYPHER Sirolimus-eluting coronary stent study

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today at European Society of Cardiology in Stockholm that the results of follow-up tests undertaken ten years after the first patient was treated with a CYPHER(R) Sirolimus-eluting coronary stent have proven outstanding long-term efficacy and safety and were published earlier this year in "JACC: Cardiovascular Interventions".

31 Aug 2010

Phase 3 AVERROES trial reveals apixaban effective for atrial fibrillation patients unsuitable for warfarin

The phase 3 AVERROES (Apixaban Versus Acetylsalicylic acid (ASA) to Prevent Strokes) trial, designed to show the superiority of apixaban over aspirin for the prevention of stroke or systemic embolism in high-risk atrial fibrillation patients unsuitable for treatment with a vitamin K antagonist (warfarin), was terminated early following a recommendation from the Data Monitoring Committee.

31 Aug 2010

Data monitoring committee recommends early termination following impressive results of AVERROES study

The data monitoring committee of the AVERROES study, seeing overwhelming evidence of the success of apixaban in the prevention of stroke in patients with atrial fibrillation who are unsuitable for the conventional treatment of warfarin, has recommended early termination of this study. The decision came after repeated review and careful consideration of all efficacy and safety data.

31 Aug 2010

$Unfractionated heparin standard dose may be optimal treatment strategy in PCI patients on fondaparinux$

Unfractionated heparin standard dose may be optimal treatment strategy in PCI patients on fondaparinux

Results from the FUTURA/OASIS 8 study presented today at the ESC Congress provide initial evidence that a low dose of unfractionated heparin does not reduce the incidence of bleeding or vascular complications in PCI patients treated with the anticoagulant fondaparinux. Findings showed that the rates of peri-PCI major bleeding were 1.4% in those given low dose heparin and 1.2% the standard dose.

31 Aug 2010

Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

Johnson & Johnson Pharmaceutical Research & Development, announced today that the investigational, oral anticoagulant rivaroxaban successfully demonstrated non-inferiority compared to the standard of care for the prevention of recurrent venous thromboembolism (VTE) in patients with acute symptomatic deep vein thrombosis (DVT), with a comparable safety profile.

31 Aug 2010

LESSON I trial provides evidence of benefits of everolimus-eluting stent over sirolimus-eluting stent

Results from the LESSON I trial presented today provide preliminary evidence for the therapeutic benefit of the newer generation everolimus-eluting stent over the previous gold standard, the early generation sirolimus-eluting stent. Moreover, LESSON I provides evidence that the formation of blood clots (stent thrombosis) - the principal shortcoming of early generation drug-eluting stents - may be diminished with the newer generation everolimus-eluting stent.

31 Aug 2010

African-Americans at higher risk of developing stent thrombosis

African-American race is a distinct risk factor for developing life-threatening blood clots after receiving a drug-coated stent, according to research reported in Circulation: Journal of the American Heart Association.

31 Aug 2010

Lack of awareness among referring physicians limits intervention in venous system: MRG

Millennium Research Group (MRG), the global authority on medical technology market intelligence, finds that although venous procedures are set to grow by more than 10% through 2013, a lack of awareness among referring physicians is a major roadblock in increased interventions in the venous system.

26 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Tasigna receives approval for chronic myeloid leukemia in Canada

Tasigna (nilotinib) capsules have been approved with conditions in Canada as a new therapy for patients with CML, in the chronic phase (first phase) of the disease. Patients must be resistant to or intolerant of at least one prior therapy, including (Pr)Gleevec (imatinib mesylate), an established standard of care.

20 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

BIOTRONIK DREAMS implanted in first patient as part of BIOSOLVE-I clinical study

A significant milestone has been reached in the development of a new therapy for patients suffering from coronary artery disease. On July 27, 2010 the BIOTRONIK DREAMS (Drug Eluting Absorbable Metal Scaffold) was successfully implanted in the first patient by Prof. Dr. Michael Haude at the Lukaskrankenhaus in Neuss, Germany as part of the first-in-man clinical study BIOSOLVE-I.

13 Aug 2010

Pulse Therapeutics receives fund to develop novel magnetics technique to destroy blood clots

BioGenerator, a non-profit, seed-stage economic development funding group, today announced that it has led a round of early-stage financing for Pulse Therapeutics, Inc., a St. Louis company headquartered at the Center for Emerging Technologies. Pulse Therapeutics develops innovative magnetism-based technology to safely destroy blood clots related to ischemic stroke and deep vein thrombosis (DVT). Other investors who participated in the round were Missouri Technology Corporation (MTC), Washington University's Olin School of Business Skandalaris Student Venture Fund, and Integrated Magnetics, of Culver City, California. The funds will be used for further pre-clinical development.

12 Aug 2010

Thrombosis News and Research

Latest Thrombosis News and Research

Researchers develop new animal model for studying hemophilia A

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Iroko Cardio International Sàrl announces data on HDB dosing of tirofiban, abciximab in interventional cardiology

XARELTO achieves net clinical benefit in treatment of patients with DVT

InfraReDx receives 510(k) clearance to market LipiScan IVUS Coronary Imaging System

ESC releases new Clinical Practice Guidelines for management of Grown-up Congenital Heart Disease

Standard dose of UFH optimal for treatment of PCI patients on fondaparinux: Study

CORDIS reports positive results from 10-year follow-up of CYPHER Sirolimus-eluting coronary stent study

Phase 3 AVERROES trial reveals apixaban effective for atrial fibrillation patients unsuitable for warfarin

Data monitoring committee recommends early termination following impressive results of AVERROES study

Unfractionated heparin standard dose may be optimal treatment strategy in PCI patients on fondaparinux

Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

LESSON I trial provides evidence of benefits of everolimus-eluting stent over sirolimus-eluting stent

African-Americans at higher risk of developing stent thrombosis

Lack of awareness among referring physicians limits intervention in venous system: MRG

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Tasigna receives approval for chronic myeloid leukemia in Canada

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

BIOTRONIK DREAMS implanted in first patient as part of BIOSOLVE-I clinical study

Pulse Therapeutics receives fund to develop novel magnetics technique to destroy blood clots

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

Thrombosis News and Research

Latest Thrombosis News and Research

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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