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Pfizer commences recruitment for Phase I clinical trial of SA3Ag vaccine

Inhibitex, Inc. today announced that its collaborator, Pfizer, Inc., has initiated patient recruitment for 408-patient, randomized, double-blind Phase I clinical trial to evaluate the safety, tolerability, and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus (S. aureus) vaccine (SA3Ag) in healthy adults.

12 Jan 2010

DSG teams up with pharmaceutical technology company to speed early detection of major diseases

DSG, a leader in electronic data capture (EDC) has teamed up with a leading-edge pharmaceutical technology company to speed the early detection of Alzheimer’s, Parkinson’s, and Diabetes.

12 Jan 2010

Yoga lowers number of compounds in blood and reduces inflammation

Regularly practicing yoga exercises may lower a number of compounds in the blood and reduce the level of inflammation that normally rises because of both normal aging and stress, a new study has shown.

12 Jan 2010

Idenix Pharmaceuticals announces significant progress in HCV development programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced significant progress in three HCV programs

12 Jan 2010

Neoprobe submits IND amendment to FDA for RIGScan CR radiopharmaceutical

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, announced today that it has submitted an investigational new drug (IND) amendment to the United States Food and Drug Administration (FDA) which includes the design of a proposed Phase 3 clinical trial of Neoprobe’s RIGScan® CR radiopharmaceutical.

12 Jan 2010

Pfizer commences SBI-087 Phase 2 clinical trial for RA

Trubion Pharmaceuticals, Inc. today announced that its collaboration partner, Pfizer, has initiated a Phase 2 clinical trial of SBI-087 (PF-05230895) for the treatment of rheumatoid arthritis (RA). SBI-087 is a next-generation, humanized Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic directed against the CD20 antigen. SBI-087 is also being evaluated in Phase 1 clinical trials for RA and systemic lupus erythematosus (SLE).

12 Jan 2010

Antares Pharma, Population Council report positive Phase 2 results for novel NES/E2 contraceptive gel

Antares Pharma, Inc. and the Population Council today announced successful results from a dose-finding Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system. Based on this successful data, the two parties continue to expect to partner with a worldwide or regional pharmaceutical company in order to commercialize this novel contraceptive gel.

12 Jan 2010

Cancer drug may provide an effective secondary treatment for gut tumor

A drug that is already an approved therapy for some cancers also might be an effective secondary treatment for a rare tumor of the gastrointestinal tract, according to a team led by researchers from the University of Pittsburgh Cancer Institute (UPCI). The findings, based on experiments using cell cultures, were published in the Jan. 1 issue of Cancer Research.

12 Jan 2010

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

KemPharm, Inc. today announced positive results from a Phase 1 clinical trial of KP106, its novel prodrug for attention-deficit hyperactivity disorder (ADHD). KP106, a new chemical entity (NCE) composed of the active pharmaceutical compound d-amphetamine and a ligand, was created using KemPharm’s proprietary Ligand Activated Therapy (LAT) prodrug approach.

12 Jan 2010

BioMarin Pharmaceutical commences BMN 195 Phase 1 clinical study for DMD

BioMarin Pharmaceutical Inc. announced today that the first subject has initiated treatment in the Phase 1 clinical study of BMN 195, a small molecule utrophin upregulator, for the treatment of Duchenne muscular dystrohpy (DMD). Initial top-line results are expected in the third quarter of 2010.

12 Jan 2010

Study demonstrates benefits of allergen immunotherapy for children with allergic rhinitis

Allergy immunotherapy, generally referred to as allergy vaccinations or shots, reduce total health care costs in children with allergic rhinitis (hay fever) by one-third, and prescription costs by 16 percent, according to a study published this month in Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI).

11 Jan 2010

Sangamo BioSciences initiates two new clinical trials of ZFP Therapeutics

Sangamo BioSciences, Inc. announced the initiation of two new clinical trials of ZFP Therapeutics, a Phase 2b study in diabetic neuropathy (DN) and a Phase 1 trial in glioblastoma, as well as the renewal of $3.0 million in funding for the Phase 2b trial by the Juvenile Diabetes Research Foundation International (JDRF).

11 Jan 2010

Exercise may improve cognitive function

Moderate physical activity performed in midlife or later appears to be associated with a reduced risk of mild cognitive impairment, whereas a six-month high-intensity aerobic exercise program may improve cognitive function in individuals who already have the condition, according to two reports in the January issue of Archives of Neurology, one of the JAMA/Archives journals.

11 Jan 2010

Results from Phase 2a clinical trial of Raptor Pharmaceutical's cysteamine bitartrate published

Raptor Pharmaceutical Corp. ("Raptor" or the "Company"), today announced the publication of results from a Phase 2a clinical trial of a prototype formulation of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

11 Jan 2010

Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Vertex Pharmaceuticals Incorporated today provided an update on key 2010 business priorities in conjunction with the 28th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also discussed recent progress in its lead development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF) and outlined proof-of-concept clinical trials planned in other serious diseases for 2010.

11 Jan 2010

Autism spectrum disorders result from miswiring of connections in developing brain

Studying a rare disorder known as tuberous sclerosis complex (TSC), researchers at Children's Hospital Boston add to a growing body of evidence suggesting that autism spectrum disorders, which affect 25 to 50 percent of TSC patients, result from a miswiring of connections in the developing brain, leading to improper information flow.

10 Jan 2010

LFB completes conversion of all acquired preferred stock

GTC Biotherapeutics, Inc. announced that LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire Français du Fractionnement et des Biotechnologies S.A., Les Ulis, France) and a strategic shareholder in GTC, has converted the convertible preferred stock it previously purchased in November 2009 under the terms described in the financing agreements approved by GTC shareholders in July 2009 into a total of 5.3 million shares of common stock.

9 Jan 2010

FDA yet to review MannKind’s NDA for insulin therapy

MannKind Corporation announced that it was informed today by the Food and Drug Administration that the FDA will not be able to complete the review of MannKind’s new drug application (NDA) for its ultra rapid-acting insulin therapy by the action date of January 16, 2010.

9 Jan 2010

Jiangsu Government grants $1.8M for research and development of hUC-MSC technologies

The Jiangsu Government's Science and Technology Department has announced a $1.8 million grant - the Jiangsu Technological Achievements Transformational Grant - to support the research and development of human umbilical cord mesenchymal stem cell (hUC-MSC) technologies. The grant recipient and administrator, Shenzhen Beike Biotechnology Co., Ltd. (http://www.beikebiotech.com ), is working with Jiangsu University and Nanjing University's Drum Tower Hospital to fulfill the grant's requirements.

9 Jan 2010

Svelte Medical Systems initiates European clinical trial for SOAW delivery system

Svelte Medical Systems, Inc. is pleased to announce that it has initiated its European clinical trial at the Thoraxcenter Research Center in Rotterdam, the Netherlands for its “Stent-on-a-Wire” (SOAW) cobalt–chromium Bare Metal Stent.

9 Jan 2010

Clinical Trial News and Research

Pfizer commences recruitment for Phase I clinical trial of SA3Ag vaccine

DSG teams up with pharmaceutical technology company to speed early detection of major diseases

Yoga lowers number of compounds in blood and reduces inflammation

Idenix Pharmaceuticals announces significant progress in HCV development programs

Neoprobe submits IND amendment to FDA for RIGScan CR radiopharmaceutical

Pfizer commences SBI-087 Phase 2 clinical trial for RA

Antares Pharma, Population Council report positive Phase 2 results for novel NES/E2 contraceptive gel

Cancer drug may provide an effective secondary treatment for gut tumor

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

BioMarin Pharmaceutical commences BMN 195 Phase 1 clinical study for DMD

Study demonstrates benefits of allergen immunotherapy for children with allergic rhinitis

Sangamo BioSciences initiates two new clinical trials of ZFP Therapeutics

Exercise may improve cognitive function

Results from Phase 2a clinical trial of Raptor Pharmaceutical's cysteamine bitartrate published

Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Autism spectrum disorders result from miswiring of connections in developing brain

LFB completes conversion of all acquired preferred stock

FDA yet to review MannKind’s NDA for insulin therapy

Jiangsu Government grants $1.8M for research and development of hUC-MSC technologies

Svelte Medical Systems initiates European clinical trial for SOAW delivery system

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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