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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

FDA grants unconditional approval for World Heart's Levacor VAD BTT study

World Heart Corporation, a developer of mechanical circulatory systems, announced today that it has received unconditional approval from the U.S. Food and Drug Administration ("FDA") for the bridge-to-transplant ("BTT") study of the Levacor Ventricular Assist Device ("VAD"). Study enrollment will encompass 160 subjects, a reduction from the approximately 200 subjects of the original statistical plan. As previously announced, the BTT study will begin initially at ten clinical sites.

8 Jan 2010

TetraLogic Pharmaceuticals commences its TL32711 SMAC mimetic Phase 1 clinical trial

TetraLogic Pharmaceuticals announced today that the Company has completed dosing of the first cohort in a Phase 1 clinical trial of its selective SMAC mimetic, TL32711. The Phase 1 trial is an open-label, dose-escalation study evaluating the safety and tolerability of TL32711 in adults with solid tumors or lymphoma refractory to standard therapies. The study will also assess the pharmacokinetics, pharmacodynamics and anti-tumor activity of TL32711.

8 Jan 2010

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

Chinese researchers have become the world's fifth most prolific contributors to peer-reviewed scientific literature on clock-reversing regenerative medicine even as a skeptical international research community condemns the practice of Chinese clinics administering unproven stem cell therapies to domestic and foreign patients.

8 Jan 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Cell Medica signs R&D agreement with the Center for Cell and Gene Therapy

Cell Medica, a clinical cellular therapeutics company developing proven cell therapies which address important unmet clinical needs in oncology and infectious diseases, announced today the signing of an R&D agreement with the Center for Cell and Gene Therapy, a joint program of Baylor College of Medicine, Texas Children’s Hospital and The Methodist Hospital, Houston, Texas.

8 Jan 2010

Clinical Trial News and Research

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

FDA grants unconditional approval for World Heart's Levacor VAD BTT study

TetraLogic Pharmaceuticals commences its TL32711 SMAC mimetic Phase 1 clinical trial

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

3Sbio submits registrational clinical trial application for Feraheme injection

Cell Medica signs R&D agreement with the Center for Cell and Gene Therapy

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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