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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

Study shows no difference between Bevacizumab and Ranibizumab efficacy in treating AMD

Researchers from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have conducted a study that failed to show a difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD).

4 Oct 2010

Research Roundups: Racial Disparities at end of life; stopping medicine mistakes; Grand Junction, Colorado's Cost Lessons

Racial Disparities In The Outcomes Of Communication On Medical Care Received Near Death Black patients receive more life prolonging measures and less comfort-directed care at the end of life (EOL) than white patients, such as increased rates of resuscitation, intensive care unit hospitalization, and feeding tube use at the EOL, write the authors of this study that examined whether differences in patient-physician communication contribute to these differences.

4 Oct 2010

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Array BioPharma Inc. today announced positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer.

4 Oct 2010

Efforts against drug-resistant malaria along Thai-Cambodian border show progress, but more 'aggressive' approach needed, health officials say

Efforts to prevent the spread of drug-resistant malaria along the border between Cambodia and Thailand are showing signs of progress, but additional work is needed to contain the new strain, health officials said on Friday, Deutsche Presse-Agentur/M&C reports.

4 Oct 2010

Bionovo enters definitive agreement to raise $3.0 million in registered direct offering

Bionovo, Inc., a drug discovery and development company focused on unmet needs in women's health and oncology, today announced that it has entered into definitive agreements to raise approximately $3.0 million in gross proceeds in a registered direct offering through the sale of common stock and warrants.

4 Oct 2010

Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

Isotechnika Pharma Inc. announces that the results of the CONFIRM1 clinical trial conducted by its medical device partner, Atrium Medical Corporation, were presented by Glenn Van Langenhove, MD, PhD (Middelheim Hospital in Antwerp, Belgium), the principal investigator, at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 Scientific Symposium in Washington, DC last week.

3 Oct 2010

VirtualScopics third-quarter revenues increase 25% to $3.5 million

VirtualScopics, Inc., a provider of quantitative imaging for clinical trials, today announced revenues for the third quarter ended September 30, 2010 exceeded $3.5 million, representing a greater than 25% increase over the comparable period in 2009 and a greater than 9% growth over the preceding quarter ended June 30, 2010. Year-to-date revenues increased over 30% for the period ended September 30, 2010 compared to the same period in 2009.

1 Oct 2010

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Emergent BioSolutions Inc. announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Emergent recently commenced a Phase I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

1 Oct 2010

Clinical Trial News and Research

BioSante to present LibiGel clinical trial update at NAMS Annual Meeting

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

Aeras Global receives FDA grant to develop biomarkers for TB vaccine

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

FDA awards $2.9 million to support tuberculosis research projects

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

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

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

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

Pharmatek adds roller compaction to GMP manufacturing facilities

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

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

Study shows no difference between Bevacizumab and Ranibizumab efficacy in treating AMD

Research Roundups: Racial Disparities at end of life; stopping medicine mistakes; Grand Junction, Colorado's Cost Lessons

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Efforts against drug-resistant malaria along Thai-Cambodian border show progress, but more 'aggressive' approach needed, health officials say

Bionovo enters definitive agreement to raise $3.0 million in registered direct offering

Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

VirtualScopics third-quarter revenues increase 25% to $3.5 million

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

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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