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.
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