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.