Sunday, 2 November 2008

FDA Approves Astellas' Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed In 5% Dextrose For The Treatment Of Hyponatremia

Astellas Pharma US, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new premixed formulation of Vaprisol: Vaprisol(R) (conivaptan hydrochloride injection) Premixed in 5% Dextrose. Discovered and developed by Astellas, Vaprisol, an arginine vasopressin (AVP) receptor antagonist, is the first and only approved drug indicated for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients.

Test Shown To Reduce Mortality By 42% For Patients With Hospital-Acquired Enterococcus Faecium Bloodstream Infections

AdvanDx today announced that a new medical study demonstrated use of AdvanDx's PNA FISHв„ў test reduced mortality by 42% for patients with highly drug resistant Hospital-Acquired Enterococcus faecium bloodstream infections (BSI's). In addition, the study demonstrated that PNA FISH reduced the time to reporting of laboratory identification results for all enterococcal BSI's by 2.6 days and reduced time to appropriate antimicrobial therapy for E. faecium BSI's by 1.8 days.

Donor Cells For Immune Therapy For Patients With Leukaemia

In the future, the bone marrow transfer to patients with leukaemia could be more secure. Experiments with mice have shown already that certain cells of the immune system (regulatory T cells or Tregs) can suppress the dangerous side effects resulting from the treatment. Such cells control aggressive immune cells and, thus, unwanted immune reactions by the graft can be avoided. However, to date, there were no adequate techniques available to securely isolate the regulatory T cells. Now, Dr.

World's First Blood-Based Diagnostic Test For Human Appendicitis - FDA 510(k) Clinical Trial Progress For AppyScore

AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported the enrollment level in the ongoing FDA 510(k) clinical trial for AppyScore(TM), the world's first blood-based diagnostic test for human appendicitis, has reached approximately 70%.

Variant CJD And Blood Transfusion

Until recently the risk of developing CJD as a consequence of a blood transfusion was a theoretical concern. However, in December 2003 a patient died from vCJD after receiving a blood transfusion from a donor who subsequently also had vCJD. Since then, three further patients have been identified. One patient died of an unrelated condition, but a post mortem examination established that the abnormal form of the prion protein was present in their body.

PharmaMar Presents New Data Of Zalypsis(R) And Irvalec(R) In Pediatric, Solid Tumours And Lymphoma

PharmaMar, a biotechnology company of Zeltia Group, has presented new data on two antitumoral compounds of marine origin, Zalypsis^ and Irvalec^, in Phase I trials in clinical development and in vitro studies and with animal models. Zalypsis^ is a novel chemical entity related to the marine natural compounds Jorumycin and the family of Renieramycins, obtained from molluscs and sponges, respectively.

Cancer Drug Vidaza(R) Receives Positive Opinion From European Regulatory Authority For Treatment Of MDS And AML

The positive opinion includes important survival data from the AZA-001 trial in higher-risk MDS patients. The CHMP, which reviews applications for all 27 Member States in the European Union (EU) as well as Norway and Iceland, has recommended approval for azacitidine. The CHMP's positive opinion will be forwarded to the European Commission, which generally follows the recommendation of the CHMP and typically issues final marketing approval within two to three months.

GPC Biotech Presents New Pre-Clinical Data On RGB-286638 Broad-Spectrum Kinase Inhibitor At EORTC-NCI-AACR Meeting

GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today reported that pre-clinical data on RGB-286638, the Company's multi-targeted protein kinase inhibitor, were presented at the 20th EORTC-NCI-AACR Symposium: Molecular Targets and Cancer Therapeutics in Geneva, Switzerland in a poster entitled, "RGB-286638 is a novel multi-targeted protein kinase inhibitor with activity in chronic myelogenous leukemia (CML) models," (Abstract #578).

Statins Show Promise For Blood Clot Prevention

Statins, the class of drugs commonly used for lowering cholesterol, are now showing promise at preventing deep vein thrombosis (DVT) or blood clots, an affliction that occurs in nearly 2 million Americans each year.

Publication On 'Tregitopes' In Blood Journal Of October 2008

Dr. Annie De Groot, CEO of EpiVax, is the lead author on an article highlighting key findings about the activation of natural regulatory T cells by IgG Fc-derived peptide, also known as Epi-13 or "Tregitopes." These findings were published in the October 8 issue of the prestigious Blood, the medical journal published by the American Society of Hematology.

Myelodysplastic Syndromes: Vidaza Receives Positve Opinion From European CHMP

The Aplastic Anemia & MDS International Foundation is pleased to inform patients that the European Committee for Medicinal Products for Human Use (CHMP) has awarded Vidaza (azacitidine) a positive opinion for the treatment of myelodysplastic syndromes (MDS) patients who are not eligible for stem cell transplants. The CHMP's positive opinion is based on data from the AZA-001 trial, which demonstrated an overall, unprecedented survival benefit for higher-risk MDS patients.

New Insight For Treating Vascular Disease

The blood circulates through the body in an intricate process that researchers are only beginning to understand. Now, University of Missouri researcher Steven Segal has received the National Heart, Lung and Blood Institute's prestigious Method to Extend Research in Time (MERIT) Award for his work in defining the signaling processes that control blood flow in the smallest, microscopic blood vessels, the microcirculation.

Better Instructions Reduce Complications Among Patients Using Common Blood Thinner

Patients who report receiving written and verbal instructions on the proper way to take the blood thinner warfarin are significantly less likely to suffer the serious gastrointestinal and brain bleeding problems that are associated with misuse of the drug, according to new research from the University of Pennsylvania School of Medicine.

The MDS Foundation Supports Vidaza's Recommendation For European Approval

The Myelodysplastic Syndromes (MDS) Foundation supports the positive opinion from the European Union's Committee for Medicinal Products for Human Use (CHMP) recommending approval of VIDAZA (azacitidine) for specific types of MDS patients, including those with high-risk MDS, chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML).

Simple Test To Predict Pre-Eclampsia In Sight

A team of UK researchers has found that women who develop pre-eclampsia in pregnancy have lower than normal levels of a marker protein in their blood at the three-month stage and this could open the door to developing a simple blood test for this potentially life-threatening condition.

Concert Pharmaceuticals Announces Preclinical Results Suggesting Potential For Once Daily Dosing Of Novel Oxazolidinone Antibiotic

Concert Pharmaceuticals, Inc. today announced findings from a preclinical study suggesting that C-20081, a novel, deuterium-containing oxazolidinone antibiotic, may be suitable for once-daily oral and intravenous dosing. In the preclinical study, C-20081 had a 43% increase in plasma half-life compared to linezolid, which might allow for lower overall drug exposure and improved tolerability with a once-daily dose.

Advances In The Science And Practice Of Transfusion And Transplantation Included In New Book

Transfusion science, a discipline of biomedicine concerned with preventing the transmission of diseases associated with blood transfusion and tissue transplantation, has made significant progress in recent years. The second edition of an informative book in this field, Transfusion Science, was recently released by Scion Publishing (http://www.scionpublishing.com).

Link Between 'Old Blood' And Infection

Blood stored for 29 days or more, nearly 2 weeks less than the current standard for blood storage, is associated with a higher infection rate in patients who received transfusions with the blood.

Gemin X Pan Bcl-2 Inhibitor Obatoclax Shows Biological, Clinical Activity In Heavily Pre-Treated Patients With Advanced Chronic Lymphocytic Leukemia

Gemin X, a clinical stage biopharmaceutical company developing novel, targeted cancer therapeutics, today announced that one of its lead oncology candidates, obatoclax, has demonstrated biological and anti-cancer activity in heavily pre-treated patients with advanced chronic lymphocytic leukemia (CLL). The results are from a Phase 1 study, and have been published in the online version of Blood, the Journal of the American Society of Hematology.

Stanford Blood Center To Honor People Who Have Donated More Than 100 Times

On Oct. 30, the Stanford Blood Center will honor more than 400 donors who have made 100 or more blood donations. "This is not your typical Silicon Valley business breakfast. This amazing group of people has helped save countless lives and their commitment to our community is remarkable," said center spokesperson Michele Hyndman. Between 7:30 and 9 a.m., donors and staff will gather at the Sheraton Hotel, 625 El Camino Real in Palo Alto, to enjoy a buffet breakfast.

Karo Bio: Successful Phase II Study Expands The Potential For Eprotirome In Dyslipidemia Treatment

Karo Bio (STO:KARO) has successfully completed a 10 week phase IIb study with eprotirome given to dyslipidemia patients undergoing treatment with the cholesterol absorption inhibitor ezetimibe. Eprotirome induced a statistically significant and clinically relevant lowering of serum LDL-cholesterol, triglycerides and lipoprotein(a) and was safe and well tolerated. Data show that eprotirome in combination with ezetimibe can become an important treatment option for patients with dyslipidemia.

Northfield Laboratories Inc. Announces Submission Of BLA For PolyHeme(R) - Human Hemoglobin-based Red Cell Substitute

Northfield Laboratories Inc. (Nasdaq: NFLD) announced today it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for PolyHeme^, the Company's human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available. Northfield also requested Priority Review, based on the potential for PolyHeme to address a critical, unmet medical need.

New Grant For Blood Substitutes

Researchers in the Department of Biological Sciences at the University of Essex have been awarded almost rS115,000 to develop a life-saving blood substitute. Anyone who has given blood or received a transfusion knows just how vital blood supplies are. Although no one would doubt the need for blood in life-saving emergencies, there are growing concerns about its use in routine operations.

Influence Of Serum Deprivation On Adherence And Proliferation Of Murine Mesenchymal Progenitor Cells Analysed With Rocherds XCELLigence System

The xCELLigence Real-Time Cell Analyzer (RTCA) System from Roche Applied Science utilizes impedance read-out to noninvasively quantify cellular status in real-time. Several cell-based applications have been developed for the xCELLigence System so far. Among them are cellular quality control, cell proliferation or cytotoxicity.

How The Body's Clot-Busting System Speeds Up Atherosclerosis

Sometimes it's hard to tell friends from foes, biologically speaking. Naturally produced in the body, urokinase plasminogen activator and plasminogen interact to break up blood clots and recruit clean-up cells to clear away debris related to inflammation. In fact, urokinase manufactured as a drug effectively clears clogged arteries by generating clot-busting plasmin from blood-derived plasminogen.

Monday, 20 October 2008

Belt And Braces Approach May Prevent Deep Vein Thromboses

Combining short periods of leg compression with medications such as heparin is more effective at preventing blood clots in high-risk patients than using either preventative measure alone. A team of Cochrane Researchers believe that this 'belt and braces' approach can significantly decrease a patient's risk of deep vein thrombosis (DVT). DVT can be fatal if the clot breaks free and travels to the lungs (pulmonary embolism).

Studying The Prevention Of Blood Clots In Cancer Patients

As more individuals with cancer are being treated as outpatients, the University of Rochester Medical Center is working on an emerging problem: how to prevent the life-threatening blood clots that can accompany some newer cancer drugs. A team of researchers, awarded $3 million this month by the National Heart, Lung and Blood Institute, is seeking to change the current standard of care by conducting a landmark clinical trial.

The International Myeloma Foundation Congratulates Friend And Collaborator Dr. Luc Montagnier For Being Awarded The Nobel Prize

The International Myeloma Foundation (IMF) - supporting research and providing education, advocacy, and support for myeloma patients, families, researchers, and physicians - today congratulated French researcher Dr. Luc Montagnier as co-recipient of the 2008 Nobel Prize in medicine. Dr.

Interim Analysis Indicating Superiority Of Fibrin Pad Versus SURGICEL In Mild To Moderate Bleeding

Omrix Biopharmaceuticals, Inc. ("Omrix") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today interim results from its U.S. Phase II clinical trial evaluating the safety and hemostatic effectiveness of the Company's Fibrin Pad product candidate as an adjunct to control mild to moderate soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery.

Study Shows Once-Daily Exjade Removes Iron From The Heart In Transfused Patients With Beta-thalassaemia

Interim study results show that once-daily Exjade^ (deferasirox) reduces iron that can build up in key organs in patients who undergo repeated blood transfusions as part of their treatment for thalassaemia.

Initial Clinical Experience With A Novel Spectroscopy Catheter That Can Identify Lipid-core Coronary Plaques

There is an unmet need for a method to identify lipid-core coronary plaques, the structures associated with most heart attacks and not detectable by conventional coronary angiography. On April 25, 2008 the U. S. FDA granted clearance to InfraReDx, Inc. for marketing of its LipiScan(TM) System to identify lipid core containing coronary plaques. Dr.

Massive Transfusion At Major Trauma Centers To Be Studied By UT Researchers

The U.S. Department of Defense has awarded The University of Texas Health Science Center at Houston a $9.2 million grant to conduct a multi-center clinical trial that could lead to an improved survival rate for trauma patients - both soldiers and civilians -- who require massive blood transfusions. The university's Center for Clinical and Translational Sciences (CCTS) is contracting with the U.S.

On The Trail Of A Targeted Therapy For Blood Cancers: Exploring Protein Critical To Blood Cell Development

Investigators from the Herman B Wells Center for Pediatric Research at the Indiana University School of Medicine are focusing on a family of blood proteins that they hope holds a key to decreasing the toxic effects of chemotherapy in children and adults. Their findings may one day help in the development of targeted therapies for leukemia, multiple myeloma and other cancers of the blood. The researchers, led by Kristin T. Chun, Ph.D.

Cerus Presents Data On Intercept Blood System At AABB Annual Meeting

Cerus Corporation (NASDAQ: CERS) announced results from 10 studies on the INTERCEPT Blood System, presented this week at the AABB annual meeting in Montreal, Canada. Study outcomes highlighted the application of the INTERCEPT Blood System for inactivation of harmful bacteria in the blood supply in place of standard bacterial screening methods and meeting certain international accreditation standards required by the AABB.

Cyclacel Announces Completion Of Enrollment In Phase 2 Trial Of Sapacitabine In Elderly AML

lCyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) announced today the completion of enrollment as per protocol in the Phase 2 clinical trial of sapacitabine, the Company's oral nucleoside analogue, in elderly patients with acute myeloid leukemia (AML). Interim results from this trial are expected to be available by the end of 2008 and final results during the second half of 2009.

Abdominal Venous Thrombosis Risk Factors

Abdominal venous thrombosis may present as BCS or SVT. Hereditary and acquired risk factors have been implicated in the etiopathogenesis of abdominal venous thrombosis. Hereditary risk factors for thrombophilia include Factor V Leiden gene mutation, Prothrombin gene mutation, homozygous methyl tetrahydrofolate reductase (MTHFR) gene mutation and deficiencies of coagulation inhibitor Protein C, Protein S and Antithrombin III.

FDA Licenses Drug To Prevent Joint Damage In Children With Hemophilia A

The U.S. Food and Drug Administration has approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia. Hemophilia A is a rare, hereditary, bleeding disorder in which a protein needed to form blood clots, factor VIII, is missing or its level is reduced. The disorder affects about 15,000 individuals in the United States, nearly all of whom are male.

Blood Supply Slipping As Economy Tumbles

New York Blood Center (NYBC), serving New York City, Long Island, Hudson Valley and New Jersey, is reporting slipping blood reserves due to increased September demand from hospitals and current economic strife. "Businesses are among our most dedicated supporters," said NYBC President and CEO Dr. Robert Jones. "Some of their scheduled corporate drives have understandably been cut back or canceled, and at the same time, demand has been going up.

FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment For Routine Prophylaxis In Children With Hemophilia A

Bayer HealthCare LLC announced that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate(R) FS Antihemophilic Factor (Recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage.

Triple Antiplatelet Therapy Appears Superior To Dual Antiplatelet Therapy

Results of five research studies and a clinical registry first-report presentation scheduled for the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF), suggest that triple antiplatelet therapy for patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents achieves greater platelet inhibition than conventional dual antiplatelet therapy.

Surgeons Test Blood Chemicals To Spot Early Signs Of Organ Injury Or Failure

Investigators at two major academic medical centers in the United States are analyzing blood chemicals that may identify the patients who are in danger of organ injury after certain types of surgery or organ failure after trauma. The hope is to develop bedside blood tests that will quickly and reliably determine which patients are at risk for organ damage so they may receive preventive treatment.

SiDMAP Launches A Metabolomics Service For Early Detection Of Drug-Induced Liver And Kidney Toxicity

SiDMAP, LLC, announced that it has expanded its SiDToxв„ў services to enable rapid and specific detection of drug-induced organ toxicity. Using its proprietary metabolomics technology platform, SiDMAP is able to monitor changes in vital metabolite fluxes in response to drug treatment to quickly determine organ toxicity before structural or morphological damage occurs. With recent advances in drug discovery, large numbers of potential new drugs have been identified.

Larger Labs Report Kidney Function Routinely

Labs that conduct the highest number of routine blood tests are more likely than others to report estimated glomerular filtration rate (eGFR), an important measure of kidney function that can identify early kidney disease, according to a survey funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH). The work is reported in the October issue of the American Journal of Kidney Diseases.

Multiple Myeloma Research Consortium Initiates Phase 1B Study Of Elotuzumab Monoclonal Antibody In Combination With REVLIMID And Dexamethasone

The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a three-drug combination study of elotuzumab (also known as HuLuc63), a humanized anti-CS1 monoclonal IgG1 antibody administered intravenously, in combination with REVLIMID^ (lenalidomide), and dexamethasone for the treatment of multiple myeloma in patients who are experiencing a relapse. Emory University's Winship Cancer Institute, Washington University, and St.

$2 Egg-Beater Could Save Lives In Developing Countries By Replacing Expensive Centrifuges

Plastic tubing taped to a handheld egg-beater could save lives in developing countries, the Royal Society of Chemistry's journal Lab on a Chip reports. The low-cost centrifuge replacement can separate plasma from blood in minutes, which is used in tests to detect lethal infectious diseases responsible for half of all deaths in developing countries.

ANGIOMAX Reduced Cardiac Mortality By 43 Percent And Improved Overall Survival By 31 Percent In Horizons-AMI Trial

The Medicines Company (NASDAQ: MDCO) today announced one-year follow-up data from the landmark HORIZONS-AMI trial demonstrated that Angiomax_ (bivalirudin) significantly reduced cardiac-related death by 43 percent (p=0.005), improved overall survival by 31 percent (p=0.029) and reduced major bleeding complications by 39 percent (p

Chronic Myeloid Leukemia - Data From EUTOS For CML Demonstrate Need For Improved Management And Dose Optimization Across Europe

One-year data from the European Treatment and Outcome Study (EUTOS) for Chronic Myeloid Leukemia (CML), presented here today, provide a clear rationale for the initiative's program of close disease management and therapeutic monitoring.

Bivalirudin Tops Treatment Standard In STEMI Patients Undergoing PCI

WASHINGTON DC- Bivalirudin (AngiomaxR) is more effective than conventional therapy involving heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), according to updated results of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial.

Researchers ID Switch Critical For Survival In Hypoxia

Hypoxia-induced injury occurs in the case of heart attack, stroke or other neurological or respiratory conditions which diminish the supply of oxygen to vital tissues and organs. Scientists know that most life forms are able to somehow suppress non-essential activity in order to survive oxygen deprivation, but they didn't know why or how this metabolic slowdown occurred.

Unique Collaborative Research Program Between Novartis And Leukaemia Physicians Across Europe Moves CML Management Forward

Data on 2,500 patients with chronic myeloid leukaemia (CML) and results from state-of-the art monitoring are providing new insights into the management of the condition, according to one-year data from a unique collaborative research programme designed to optimise the treatment and monitoring of patients throughout Europe. The

Thursday, 2 October 2008

Costs Of Home Hemodialysis Offset By Better Health, Fewer Hospitalizations

Daily hemodialysis administered in patients' homes is associated with better health outcomes compared with peritoneal dialysis, according to an article in the October issue of the American Journal of Kidney Diseases, the official journal of the National Kidney Foundation.

Young People To Learn About The Power Of Giving

Students in classrooms across the UK will be able to learn about the dramatic effects of blood, organ, bone marrow and tissue donation and how they, too, can become lifesavers by choosing to donate, thanks to 'Give and Let Live', a free education pack issued by NHS Blood and Transplant (NHSBT). The teaching resource is aimed primarily at 14 to16 year old students but can be adapted for younger pupils, or 6 th formers.

Warfarin Linked To Increased Bleeding In Brain

A new study shows that people who take the commonly used blood thinning drug warfarin may have larger amounts of bleeding in the brain and increased risk of death if they suffer a hemorrhagic stroke. The study is published in the September 30, 2008, print issue of Neurology^, the medical journal of the American Academy of Neurology. Warfarin is commonly prescribed to prevent blood clotting.

Response To 'Blood Thinning Drug Linked To Increased Bleeding In Brain' In Neurology

Dr Peter Coleman from The Stroke Association commented: "We urge people to continue to take Warfarin as prescribed by their doctor. It is important that they know the correct dosage and that they have follow up blood tests so make sure the speed at which the blood is clotting is controlled. This will prevent uncontrolled bleeding.

Non-invasively Measuring Blood Flow Using Magnetic Resonance Imaging - NOVAв„ў Now Available In Europe

NOVAв„ў, the most advanced technology to quantitatively and non-invasively measure blood flow using magnetic resonance imaging, will now be available to vascular patients in Europe. Developer and producer VasSol, Inc. this month announced their partnership with Italian distributor Tekmed Instruments. Starting in October, Tekmed Instruments will offer NOVAв„ў (Non-invasive Optimal Vessel Analysis) Quantitative MRA, or QMRA, software for licensing throughout Italy.

British Lymphology Society Chooses Belfast For Prestigious Annual Conference

The British Lymphology Society (BLS), the only UK body representing the medical professionals who treat lymphoedema, has chosen Belfast as the venue for its high profile annual conference. Nearly 200 nursing and physiotherapy delegates, plus 11 pharmaceutical companies will be gathering at the Wellington Park Hotel for three days; 5-7 October.

Scientists Establish New Blood Test To Better Evaluate Prostate Cancer

An international study led by researchers at The Institute of Cancer Research will pave the way for a test to be used to better tailor treatments and hopefully extend the survival of men with aggressive forms of metastatic prostate cancer.

The International Myeloma Foundation Applauds Expansion Of VELCADE(R) For Previously Untreated Patients In Europe And Canada

The International Myeloma Foundation (IMF) - supporting research and providing education, advocacy, and support for myeloma patients, families, researchers, and physicians - today heralded the expansion of treatment options for previously untreated patients with multiple myeloma, giving patients in Canada and Europe access to drugs similar to what is available to patients in the United States.

Stroke Patients Benefit From Dissolving A Blood Clot In The Brain Up To 4.5 Hours After A Stroke

Patients can still benefit up to 4.5 hours after a stroke if a drug that dissolves blood clots in the brain is administered. Thus far, three hours had been considered the useful limit for administering thrombolytic drugs. The results of the "European Cooperative Acute Stroke Study 3" (ECASS 3) have now been published in the New England Journal of Medicine.

Bayer's Novel Anticoagulant Xarelto^ Now Also Approved In The EU

The Bayer Group has achieved a major success in its product development: The European Commission has granted marketing approval for Xarelto^ (rivaroxaban), a novel anticoagulant taken as one tablet, once-daily, for the prevention of venous blood clots in adult patients undergoing elective (planned) hip or knee replacement surgery. Bayer HealthCare will start launching the product in the EU member states very soon.

AHRQ Awards $3 Million To Help Reduce Central Line-Associated BloodStream Infections In Hospital ICUs

The Agency for Healthcare Research and Quality has awarded nearly $3 million for a contract to help reduce central line-associated bloodstream infections in hospital intensive care units (ICUs) by spreading the knowledge gained from a previous AHRQ-funded project. The Health Research & Educational Trust, an affiliate of the American Hospital Association, has been selected to coordinate the new 3-year project, which is part of an AHRQ initiative to reduce health care-associated infections.

Research Shows New Class Of Stent Effective In Preventing Thrombosis, Restenosis, And Reocclusion

CeloNova BioSciences, Inc., announced that Masahiko Ochiai MD, Associate Professor, Division of Cardiology, Yokohama Hospital, Kanagawa, Japan has selected the CATANIA(TM) Coronary Stent System featuring NanoThin Polyzene(R)-F for treating a patient with a chronic total occlusion (CTO) during a live case symposium at the Paris Cardiovascular Interventions (Francophone) Congress.

CLSI Publishes Updated Standard For Collection Of Diagnostic Capillary Blood Specimens

Clinical and Laboratory Standards Institute (CLSI) recently published an updated standard, Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard--Sixth Edition (H04-A6), which provides a technique for the collection of diagnostic capillary blood specimens, including recommendations for collection sites and specimen handling and identification.

Tuesday, 30 September 2008

Genmab Completes Recruitment Of Patients In The Phase II Study Of Ofatumumab In Combination With CHOP Chemotherapy

Genmab A/S (OMX: GEN) announced it has completed recruitment of 56 previously untreated follicular non-Hodgkin's lymphoma (NHL) patients in the Phase II study of ofatumumab (HuMax-CD20(R)) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP). "We are happy to finish enrolment in this first study with ofatumumab in front line follicular NHL patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer at Genmab.

Healthy Blood Vessels May Prevent Fat Growth

The cells lining blood vessels are known to be important for maintaining health, but researchers at the Indiana University School of Medicine believe these cells may perform an unsuspected task - controlling the development of fat cells. Their findings are reported in the September issue of the journal Stem Cells.

Iron-Moving Malfunction May Underlie Neurodegenerative Diseases, Aging

A glitch in the ability to move iron around in cells may underlie a disease known as Type IV mucolipidosis (ML4) and the suite of symptoms---mental retardation, poor vision and diminished motor abilities---that accompany it, new research at the University of Michigan shows.

NIH Fast Track Grant Awarded To Arteriocyte For Critical Limb Ischemia Research

Arteriocyte, a clinical stage biotechnology company announced today the receipt of a fast track Phase I/II Small Business Innovation Research Grant Award (R44HL092706-01) from National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of Health (NIH). The grant award, is the first installment of the combined $2.

Potential Cure For Children With Sickle Cell Disease Evaluated In Nationwide Research Study

A first-of-its-kind clinical trial may provide new treatment options to children with sickle cell disease (SCD), an inherited blood disorder that affects 70,000 people in the United States. The Sickle Cell Unrelated Transplant (SCURT) research study is a Phase II, multi-site clinical trial that will start accepting qualified patients later this month. Currently, marrow or blood stem cell transplantation is the only potential cure for severe SCD.

Omrix Completes Enrollment Of Initial 90 Patients Needed To Conduct Interim Analysis In Fibrin Pad U.S. Phase II Clinical Trial

Omrix Biopharmaceuticals, Inc. ("Omrix") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has completed enrollment of the first 90 patients in its Phase II clinical trial for the Fibrin Pad in mild to moderate bleeding. The Company expects to release 90 patient interim efficacy analysis by the end of October 2008.

AVEO Pharmaceuticals Initiates First Clinical Trial Of Novel HGF Antagonist In Patients With Advanced Solid Tumors And Lymphomas

AVEO Pharmaceuticals, Inc., announced that it has initiated a Phase 1 clinical trial to evaluate the safety, tolerability and recommended dose of SCH900105 (AV-299), its novel, highly potent antibody to hepatocyte growth factor (HGF), administered intravenously in patients with relapsed or refractory solid tumors or lymphoma. SCH900105 (AV-299) is being developed in collaboration with Schering-Plough (NYSE: SGP).

Beaumont Doctor Invents Device To Improve Blood Clot Treatment Outcomes

The Beaumont Commercialization Center, a medical device development company within Beaumont Hospitals, has a new surgical instrument available for licensing. Paul J. Arpasi, M.D., a Beaumont radiologist, developed a device that will help reduce the risk for excessive bleeding and infection by allowing multiple catheters or other devices to be connected to a patient from a single puncture site.

Maisonneuve Rosemont Hospital To Become Leader In Stem Cell Research, Canada

Maisonneuve-Rosemont Hospital (MRH), which is affiliated to the UniversitsY de MontrsYal, plans to open the Centre d'excellence en thsYrapie cellulaire (CETC) in 2010. The CETC will focus on stem cell research, regenerative medicine and different types of blood cancers. "Our hope is to have a world class hemo-oncology center such as the Sloan-Kettering Cancer Center in New York," says hematologist Dr.

Nice Approves Pradaxa(R)(Dabigatran Etexilate) - 1st New Oral Anticoagulant In UK For Over 50 Years

Clinicians and patient groups have welcomed today's announcement by the National Institute of Health and Clinical Excellence (NICE) recommending Pradaxa(R) (dabigatran etexilate) as an option for the primary prevention of venous thrombembolic events in adults who have undergone elective total hip or total knee replacement surgery.

Non-Hodgkin's Lymphoma - Recruitment Completed In Ofatumumab NHL Pivotal Study

Genmab A/S (OMX: GEN) announced it has completed recruitment of patients in the pivotal Phase III study of ofatumumab (HuMax-CD20(R)) in rituximab refractory follicular non-Hodgkin's lymphoma (NHL). Eighty-one patients receiving treatment at the 1000 mg dose level of ofatumumab have been recruited in the study. Data from these patients will be included in the primary efficacy analysis.

AdvanDx Receives FDA 510(k) Clearance For Yeast Traffic Light PNA FISH

AdvanDx announced it received FDA 510(k) clearance of the Yeast Traffic Light PNA FISHв„ў to identify Candida yeast species directly from positive blood cultures. The Yeast Traffic Lightв„ў is the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISHв„ў diagnostics platform that provides rapid identification of bloodstream pathogens in hours instead of days.

Zibor(R), A Second-generation Low Molecular Weight Heparin, Only One Licensed In The UK

Archimedes Pharma UK Limited, the UK based, pan-European specialty pharmaceutical company, announces the launch of Zibor^ (bemiparin sodium) to the UK market. A second-generation low molecular weight heparin (LMWH), Zibor is the only LMWH licensed in the UK for post-operative initiation of thromboprophylaxis in any patients undergoing orthopaedic and general surgery. Already used by over 5 million patients worldwide, Zibor enters the UK market as the lowest priced LMWH.

DKMS And The Leukemia & Lymphoma Society's New York City Chapter Announce Partnership

DKMS, the world's largest bone marrow donor center, and The Leukemia & Lymphoma Society's New York City Chapter will team up at this year's Light The Night Walk(R) to pay homage to patients battling cancer and to recruit bone marrow donors needed to give hope to more patients suffering from life-threatening blood diseases, such as leukemia and lymphoma.

PolyMedix Initiates Dosing In Phase I Clinical Study Of Novel Anticoagulant Antagonist Compound

PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a Phase I clinical study in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).

Joint Commission Alert: Prevent Blood Thinner Deaths And Overdoses

A number of recent high profile errors related to commonly used blood thinners highlight a safety issue that too frequently results in harm or even death to patients, according to a Joint Commission alert issued that offers solutions to this medication safety issue.

Joint Commission Alert: Prevent Blood Thinner Deaths And Overdoses - Anticoagulant Therapy Linked To High Rate Of Errors

A number of recent high profile errors related to commonly used blood thinners highlight a safety issue that too frequently results in harm or even death to patients, according to a Joint Commission alert issued today that offers solutions to this medication safety issue.

Chinese Officials Announce Stricter Punishment For Contaminated Blood Sales

The Supreme People's Court and the Supreme People's Procuratorate of China recently released details of a new law regarding illegal blood sales, which state that any agent collecting or supplying blood that causes at least five people to become infected with HIV/AIDS, hepatitis B, hepatitis C or syphilis could face a sentence of 10 years to life in prison, the

NICE Issues Guidance On The Prevention Of Venous Thromboembolism, UK

The National Institute for Health and Clinical Excellence (NICE) has published final guidance on the use of dabigatran etexilate for the prevention of venous thromboembolic events after elective total hip or elective total knee replacement surgery in adults. NICE produced the guidance as part of its rapid single technology appraisal (STA) work programme.

Novartis' Once Daily Iron Chelator, Exjade(R) (deferasirox) Awarded Prestigious UK Prix Galien Medicines Prize

Exjade (deferasirox) has been awarded a prestigious Prix Galien award for innovative research and development in orphan drugs. The once-daily oral iron chelator from Novartis treats patients with transfusion iron overload. Novartis' new anti-cancer targeted agent, Tasigna (nilotinib) was also commended by judges, including Sir Michael Rawlins of National Institute for Health and Clinical Excellence.

Nottingham Scientists To Develop Blood Test For Alzheimer's

Researchers from Nottingham's two universities are joining forces to develop a simple blood test to diagnose Alzheimer's disease. The rS200,000 study, funded by the leading charity the Alzheimer's Research Trust, will aim to find out whether 'biomarkers' in blood could be used to identify someone with Alzheimer's. A biomarker is a term for something present in the body which can indicate disease, such as a certain protein or molecule.

Core Needle Breast Biopsies Safe For Patients Taking Blood Thinners

It is safe to take anticoagulants (blood thinners) before core needle breast biopsies, according to a study performed at the Elizabeth Wende Breast Clinic in Rochester, NY. Core needle biopsies are offered as an alternative to surgical biopsy when a tissue sample of an irregular area in the breast is found by mammogram or sonogram. "They are safer than surgical procedures, require fewer anesthetics, and are accurate," according to Patricia Somerville, MD, lead author of the study.

Survey Shows General Public More Worried About Cancer Today Than 10 Years Ago

New research has revealed we are more concerned about cancer now than we were 10 years ago - even though we know the outlook for anyone diagnosed with cancer today is more positive than ever1.

Do You Know Your Nodes? Message From The Lymphoma Association And Leukaemia CARE, UK

Know Your Nodes! That's the message the Lymphoma Association and Leukaemia CARE are spreading ahead of World Lymphoma Awareness Day (WLAD), an event held annually on September 15th which aims to inform the public about lymphoma; the sixth most common cancer in the UK.