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Saneron receives grant to develop safety guidelines for transplanting HUBC cells in Alzheimer's disease

The National Institutes of Health has awarded a three-year, $2.6-million grant to the University of South Florida and Tampa-based biotechnology company Saneron-CCEL Therapeutics, Inc., to establish dosing and safety guidelines for transplanting human umbilical cord blood cells (HUBC) into animal models of Alzheimer's disease.

6 Oct 2010

Amino acid mixture increases survival in mice

When mice are given drinking water laced with a special concoction of amino acids, they live longer than your average mouse, according to a new report in the October issue of Cell Metabolism, a Cell Press publication. The key ingredients in the supplemental mixture are so-called branched-chain amino acids, which account for 3 of the 20 amino acids (specifically leucine, isoleucine, and valine) that are the building blocks of proteins.

6 Oct 2010

Lixte, NCI collaborate for clinical evaluation of LB-100 compound

Lixte Biotechnology Holdings announced today that the National Cancer Institute Experimental Therapeutics (NExT) Program Senior Advisory Committee (SAC), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), National Institutes of Health (NIH), signed a NExT Material Transfer Agreement formalizing a collaboration with Lixte Biotechnology Holdings, Inc. for clinical evaluation of LB-100, one of Lixte's lead anti-cancer compounds.

6 Oct 2010

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

Liquidia Technologies, a privately held nanotechnology company developing particle-based vaccines and therapeutics, today announced the initiation of human dosing of its lead vaccine product candidate, LIQ-001, in a Phase 1 clinical trial. LIQ-001, the first in a pipeline of PRINT® vaccines, is being developed as a seasonal influenza vaccine for enhanced protection in the elderly and represents the company's migration from proof of concept to the clinical application of PRINT technology.

5 Oct 2010

DATATRAK receives consulting contract to provide clinical data management

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the award of a consulting contract with an existing global research-based biopharmaceutical client to provide clinical data management and trial design services.

5 Oct 2010

FDA grants orphan drug designation to hGH-CTP for treating growth hormone deficiency

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone for the treatment of growth hormone deficiency.

5 Oct 2010

Supplemental brief dynamic therapy does not benefit patients with obsessive-compulsive disorder: Study

This study demonstrates that supplemental brief dynamic therapy in the treatment of patients with obsessive compulsive-disorder with concurrent major depressive disorder (who are receiving effective medication) has no significant clinical effect on both obsessive and depressive symptoms.

5 Oct 2010

RHUCIN clinical trial results published in JACI journal

Santarus, Inc., a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI).

5 Oct 2010

BioSante to present LibiGel clinical trial update at NAMS Annual Meeting

BioSante Pharmaceuticals, Inc. today announced that it will present a LibiGel clinical trial update at the 21st Annual Meeting of The North American Menopause Society (NAMS) being held from October 6-9, 2010 at the Sheraton Chicago Hotel & Towers in Chicago, Illinois.

5 Oct 2010

Family based treatment more effective than traditional individual-based therapy for anorexia nervosa

An anorexia nervosa treatment strategy that promotes parental involvement in restoring an adolescent to healthy weight and eating habits is more effective than traditional individual-based anorexia nervosa therapy, according to new research.

5 Oct 2010

Aeras Global receives FDA grant to develop biomarkers for TB vaccine

The Aeras Global TB Vaccine Foundation is pleased to announce receipt of a grant from the United States Food and Drug Administration (FDA) to develop new biological and immunological biomarkers for TB vaccine development. The FDA grant, which supports the coordination of a multi-investigator project with researchers from the United States, the United Kingdom and South Africa, will provide $362,102 in the first year of funding.

5 Oct 2010

Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Celldex Therapeutics, Inc. today announced that the Company presented initial clinical data on CDX-1401 at the 25th Annual Meeting of the International Society of Biological Therapy of Cancer (iSBTc) in Washington, DC. CDX-1401 is a novel antibody-based targeted cancer vaccine candidate being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.

5 Oct 2010

FDA awards $2.9 million to support tuberculosis research projects

The U.S. Food and Drug Administration today announced the award of $2.9 million to support six research projects that will help with the diagnosis, treatment, and prevention of tuberculosis (TB).

5 Oct 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Enzo Biochem, Inc., announced today that, following filing of a investigational new drug (IND) application with the FDA, its Enzo Therapeutics division is commencing a clinical trial of Optiquel™ , the Company's proprietary oral therapeutic for chronic non-infectious uveitis. The trial is designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up and is being conducted by the National Institute of Health's National Eye Institute (NEI).

4 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Pharmatek adds roller compaction to GMP manufacturing facilities

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has added roller compaction to its solid oral dosage form manufacturing capabilities. The company has purchased two roller compactors, a pilot-scale Vector TFC-220 roller compactor with a rate of 20 kg/hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a rate of 1 kg/hour. Both machines have been integrated into Pharmatek's GMP facility and are ready for GMP manufacturing.

4 Oct 2010

AVEO Pharmaceuticals to present tivozanib Phase 2 study results at IKCS Symposium

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) will be presented at the Ninth International Kidney Cancer Symposium (IKCS) in Chicago, Illinois, October 1-2, 2010.

4 Oct 2010

Look AHEAD intervention program improves risk factors in obese, type 2 diabetic patients

An intensive lifestyle intervention program designed to achieve and maintain weight loss improves diabetes control and cardiovascular disease risk factors in overweight and obese individuals with type 2 diabetes, according to four-year results of the Look AHEAD study, funded by the National Institutes of Health and the Centers for Disease Control and Prevention. The results are published in the Sept. 27, 2010, issue of the Archives of Internal Medicine.

4 Oct 2010