Thrombosis News and Research

Latest Thrombosis News and Research

PolyMedix's PMX-60056 Phase 1B/2 dose-ranging clinical study for heparin reversal meets study endpoints

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has successfully completed a Phase 1B/2 dose-ranging clinical study with PMX-60056, a synthetic small-molecule designed to reverse heparin and low molecular weight heparin anticoagulants.

11 Aug 2010

InspireMD announces availability of new delivery system for MGuard stent

InspireMD Ltd. is announcing today the availability of a new and improved delivery system for its MGuard coronary stent system. The new delivery system, which has already been introduced in selected regions around the world, will now make its launch in South America during SOLACI 2010, taking place at the Hilton Hotel in Buenos Aires, Argentina, August 11th-13th.

11 Aug 2010

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

9 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Blood coagulation, antimicrobial defence processes are functionally coupled: Research

The adaptive immune system can recognize and respond specifically to particular infectious agents. But the first line of defence against pathogens is the so-called innate immune system. This system reacts to invaders by initiating unspecific inflammatory responses which attract various types of specialized cells such as neutrophils to the site of the incursion.

4 Aug 2010

Boston Scientific initiates enrollment in EVOLVE clinical trial of SYNERGY Coronary Stent

Boston Scientific Corporation today announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY™ Coronary Stent. The first patient was enrolled by Ian Meredith, M.B.B.S., Ph.D., Professor and Director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.

4 Aug 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

First generic version of Lovenox receives FDA approval for DVT

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis, a potentially deadly blood clotting condition.

23 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

GTC Biotherapeutics regains US commercialization rights to ATryn from Lundbeck

GTC Biotherapeutics, Inc. announced today that it has signed a definitive agreement whereby the Company has regained US commercialization rights to ATryn from Lundbeck, Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark.

17 Jul 2010

BioInvent reports net revenues of SEK 63.1M for January - June 2010 period

BioInvent reached an important milestone when the results of a phase II trial of TB-402 following orthopaedic surgery, were reported in May. The data showed that TB-402 is statistically better at preventing thrombosis than enoxaparin, the current standard treatment. Supported by these good results, BioInvent and the company's partner, ThromboGenics, will now prioritise securing a development partner for the programme to ensure that the necessary resources is in place to take the product candidate to the market.

14 Jul 2010

Accumetrics, Daiichi Sankyo, Eli Lilly collaborate to raise awareness about antiplatelet therapy

Accumetrics, Inc., Daiichi Sankyo, Inc, and Eli Lilly and Company announced today that the companies have entered into a strategic collaboration in the United States to raise awareness about antiplatelet therapy and the role of platelet function testing.

12 Jul 2010

AngioDynamics adds low-profile, mini models to Smart Port CT family of power-injectable ports

AngioDynamics announced today the global expansion of its Smart Port CT family of power-injectable ports, featuring its patented Vortex® port technology - to include low-profile and mini models for repeated treatments such as chemotherapy and for use with computed tomography (CT).

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec and Swedish Orphan Biovitrum AB today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies' long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

12 Jul 2010

Semuloparin reduces incidence of VTE in orthopedic surgery patients, study finds

An ultra-low-molecular-weight heparin called semuloparin has been found to reduce the incidence of venous thromboembolism in orthopedic surgery patients in a large clinical program being lead by a steering committee chaired by McMaster University professor Dr. Alexander Turpie.

9 Jul 2010

Phase II trial results of TB-402 presented at International Congress on Thrombosis

BioInvent International AB and ThromboGenics NV announce that the positive results from a Phase II trial of TB-402 (Anti-Factor VIII antibody) were presented at the 21st International Congress on Thrombosis in Milan, Italy yesterday. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism following orthopaedic surgery.

9 Jul 2010

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Daiichi Sankyo, Inc. and Eli Lilly and Company appreciate the availability of a "Clinical Alert" from the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) in response to the FDA's Boxed Warning about Plavix® (clopidogrel), and commend the leading cardiovascular medical societies for providing perspective on the importance of genetic make-up and the variability in response of certain oral anti-platelet (OAP) therapy for patients with acute coronary syndrome (ACS) who are managed with angioplasty and stenting (known as PCI).

29 Jun 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

Phadia's four new EliA autoimmune antibody assays receive FDA clearance

Today Phadia announced that it has received FDA 510 (K) clearance for four new EliA autoimmune antibody assays. These new assays will provide physicians with additional tools needed to aid in the diagnosis of Antiphospholipid Syndrome. The newly available EliA assays, anti-cardiolipin (aCL) IgG/IgM and anti-B2-glycoprotein 1 (anti-B2-GP1) IgG/IgM, have proven to be essential, sensitive, and specific markers to aid in the diagnosis of APS.

25 Jun 2010

Thrombosis News and Research

Latest Thrombosis News and Research

PolyMedix's PMX-60056 Phase 1B/2 dose-ranging clinical study for heparin reversal meets study endpoints

InspireMD announces availability of new delivery system for MGuard stent

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Blood coagulation, antimicrobial defence processes are functionally coupled: Research

Boston Scientific initiates enrollment in EVOLVE clinical trial of SYNERGY Coronary Stent

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

First generic version of Lovenox receives FDA approval for DVT

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

GTC Biotherapeutics regains US commercialization rights to ATryn from Lundbeck

BioInvent reports net revenues of SEK 63.1M for January - June 2010 period

Accumetrics, Daiichi Sankyo, Eli Lilly collaborate to raise awareness about antiplatelet therapy

AngioDynamics adds low-profile, mini models to Smart Port CT family of power-injectable ports

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Semuloparin reduces incidence of VTE in orthopedic surgery patients, study finds

Phase II trial results of TB-402 presented at International Congress on Thrombosis

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Japan's MHLW grants full marketing authorization to REVLIMID

Phadia's four new EliA autoimmune antibody assays receive FDA clearance

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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