The Food and Drug Administration can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced way according to the American Clinical Laboratory Association (ACLA). ACLA, which represents the nation’s leading clinical laboratories, says that the factors supporting this approach include the growing role that such tests play in clinical decision making, especially in the area of new advanced diagnostics that derive from the mapping of the human genome and help fulfill the promise of personalized medicine.

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in regenerative therapies for the treatment of cardiovascular diseases, today announces positive safety data and preliminary efficacy results from its clinical trial of C-Cure(R), a breakthrough stem cell therapy for heart failure.

Advaxis, Inc.,, the live, attenuated Listeria monocytogenes (Lm) biotechnology company, enrolled and has administered its initial dose to its third patient in its US Food and Drug Administration (FDA)-approved, phase II clinical trial in cervical intraepithelial neoplasia (CIN), commonly known as cervical dysplasia.

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of the first clinical data for the Company’s IMGN388 anticancer compound at the 2010 Annual Meeting of the American Society of Clinical Oncology being held in Chicago, IL.

Alder Biopharmaceuticals Inc. today announced that patients with late-stage non-small cell lung cancer (NSCLC) showed improvement in cancer-related anemia and symptoms of the disease in a Phase 2a clinical trial of ALD518, a monoclonal antibody directed against interleukin-6 (IL-6).

ChemGenex Pharmaceuticals Limited announced that positive safety findings from a combined analysis of two clinical trials for its lead product candidate, OMAPRO’

Researchers, led by Kerri Boutelle, PhD, associate professor of pediatrics and psychiatry at the University of California, San Diego School of Medicine have found that obesity is a risk factor for depressive symptoms, but not for clinical depression, suggesting that weight status could play a part in the development of depression in some adolescent girls.

ImaginAb, Inc. and the GSK Clinical Imaging Centre (part of the GlaxoSmithKline Group of Companies) have concluded two research collaboration agreements around a clinical therapeutic antibody asset currently under development by GSK in the field of oncology.

Amgen Inc. today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denosumab, a subcutaneous RANK Ligand inhibitor. The BLA submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus Zometa® (zoledronic acid).

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, today announced the latest version of the Phase Forward Clinical Development Center, a centralized solution for integrating, managing and analyzing clinical information.