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ConvaTec presents Vitala Continence Control Device Phase 2 data at 2010 WOCN/WCET joint conference

ConvaTec, a world-leading developer of innovative medical technologies for community and hospital care, today presented data supporting the safety and efficacy of Vitala™, a novel, non-intrusive pouchless ostomy device that provides temporary continence to people with a colostomy. The clinical trial data were presented at the 2010 Joint Conference of the Wound, Ostomy and Continence Nurses Society (WOCN) and World Council of Enterostomal Therapists (WCET), where the new device is being previewed to U.S. and global healthcare professionals.

15 Jun 2010

MultiCell retains CDSS to manage MCT-125 Phase IIb clinical trial for PMSF in UK

MultiCell Technologies, Inc. has retained Clinical Development & Support Services, Ltd. (CDSS) of Cheshire, England to manage its planned Phase IIb clinical trial in the United Kingdom for MCT-125, the Company's lead drug candidate for treatment of primary multiple sclerosis-related fatigue (PMSF).

14 Jun 2010

Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Upsher-Smith Laboratories, Inc. today announced the initiation of a global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology. USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

14 Jun 2010

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Calistoga Pharmaceuticals, Inc., the leader in the development of isoform-selective phosphatidylinositol 3 kinase (PI3K) inhibitors for the treatment of cancer and inflammatory diseases, today presented preclinical and clinical data on CAL-101, the Company's oral, delta selective PI3K inhibitor at the 15th Congress of the European Hematology Association in Barcelona, Spain.

14 Jun 2010

Medidata Solutions launches new RTSM solution for clinical research sponsors, sites

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today introduced Medidata Balance™, a new randomization and trial supply management (RTSM) solution for clinical research sponsors and sites.

14 Jun 2010

Study evaluates correlation between EverOn system and detection of patient deterioration in hospitals

EarlySense, developer of the EverOn contact-free, patient supervision system for hospital and post acute care, announced today the results of a multicenter study conducted at several hospitals in the United States and Israel. The data were recently made public by Drs. Eyal Zimlichman, Martine Szyper-Kravitz, Howard Amital, and Yehuda Shoenfeld at the American Thoracic Society Conference in New Orleans in a presentation titled, Recognizing Specific Respiratory Patterns Preceding in Hospital Clinical Deterioration, a Multicenter Study.

14 Jun 2010

BioClinica eClinical Technology Suite and BIOP to be showcased at DIA Annual Meeting

BioClinica, Inc., a global provider of clinical trial management services, will exhibit at the 46th Drug Information Association Annual Meeting from June 13-17, 2010 in Washington, D.C., where it will showcase the BioClinica eClinical Technology Suite as well as introduce the BioClinica Integrated Operations Platform.

From Clario 14 Jun 2010

Endosense awards DATATRAK first two EFFICAS studies

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced that medical technology company Endosense has awarded DATATRAK the first two studies in the EFFICAS study series. The EFFICAS studies are intended to demonstrate that the use of contact force control during cardiac ablation utilizing Endosense's TactiCath® force-sensing catheter results in superior outcomes as compared to ablations performed without a force sensor.

14 Jun 2010

Medidata Solutions introduces Grants Manager 3.0 to select correct procedure for budgeting in trial

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today introduced Medidata Grants Manager 3.0, the newest version of its trial budgeting application in use today by many of the innovative clinical research sponsors in the life sciences industry. Now offered as a web-based solution, Grants Manager 3.0 enables users to build clinical trial grant budgets and benchmark them against Medidata's unique PICAS database of negotiated trial costs without the need to install software.

14 Jun 2010

CAMD releases first combined clinical trial data on neuro-degenerative diseases

A new database of more than 4,000 Alzheimer's disease patients who have participated in 11 industry-sponsored clinical trials will be released today by the Coalition Against Major Diseases (CAMD). This is the first database of combined clinical trials to be openly shared by pharmaceutical companies and made available to qualified researchers around the world.

14 Jun 2010

Synexus invests in Doppler Ultrasound for 7 UK-based Dedicated Research Centres

Manchester-based Synexus, the world's largest multi-national company dedicated to the recruitment and running of clinical trials, has recently invested in Doppler Ultrasound equipment for each of its seven UK-based Dedicated Research Centres. After training for all Synexus' doctors, the facilities are now being used as part of the drive to recruit patients to a new diabetes study.

From AES - Accelerated Enrollment Solutions 14 Jun 2010

ARCA receives approval to commence enrollment of first therapeutic trial using HIV vaccine candidate

News on the progress of a new trial may give new hope to patients with HIV who are dependent on anti-HIV drugs. The AIDS Research Consortium of Atlanta has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from Atlanta-based, GeoVax Inc, a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines.

14 Jun 2010

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting.

14 Jun 2010

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Cell Therapeutics, Inc. today announced that the Italian Medicines Agency ("AIFA"), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone.

14 Jun 2010

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH and a principal investigator of the U.S. Phase 2b RESTORE-CLI clinical trial sponsored by Aastrom Biosciences, will present the full results from the interim analysis at today's session of the annual meeting of the Society for Vascular Surgery.

11 Jun 2010

Trevena's scientists present research data on GPCR biased ligands at two scientific conferences

Trevena Inc., a leader in the discovery of G-protein coupled receptor biased ligands, today announced that its scientists are presenting research data at two scientific conferences. These oral presentations highlight Trevena's research demonstrating that ligand bias at the angiotensin II type I receptor translates into differentiable and beneficial cardiovascular pharmacology in vivo.

11 Jun 2010

NeoPharm first-quarter net loss decreases to $1.4 million

NeoPharm, Inc., a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced its first quarter 2010 financial results.

11 Jun 2010

Cook Medical files for PMA of Zilver PTX Drug-Eluting Peripheral Stent with FDA

Cook Medical has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the company's unique polymer-free Zilver® PTX® Drug-Eluting Peripheral Stent. Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), Zilver PTX is a self-expanding, highly durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an antiproliferative drug, to the target lesion.

11 Jun 2010

Otonomy completes $10 million Series A financing with Avalon Ventures

Otonomy, Inc. announced today that it has completed a $10 million Series A financing with Avalon Ventures. Proceeds from the financing will be used to support the ongoing clinical trial for OTO-104 in Meniere's disease, initiate IND-enabling studies for OTO-203, and continue early-stage development of a third program.

11 Jun 2010

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced data from a subgroup analysis of a Phase 2 randomized discontinuation trial showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell renal cell carcinoma (RCC) who had undergone a prior nephrectomy was 14.8 months.

11 Jun 2010

Clinical Trial News and Research

ConvaTec presents Vitala Continence Control Device Phase 2 data at 2010 WOCN/WCET joint conference

MultiCell retains CDSS to manage MCT-125 Phase IIb clinical trial for PMSF in UK

Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Medidata Solutions launches new RTSM solution for clinical research sponsors, sites

Study evaluates correlation between EverOn system and detection of patient deterioration in hospitals

BioClinica eClinical Technology Suite and BIOP to be showcased at DIA Annual Meeting

Endosense awards DATATRAK first two EFFICAS studies

Medidata Solutions introduces Grants Manager 3.0 to select correct procedure for budgeting in trial

CAMD releases first combined clinical trial data on neuro-degenerative diseases

Synexus invests in Doppler Ultrasound for 7 UK-based Dedicated Research Centres

ARCA receives approval to commence enrollment of first therapeutic trial using HIV vaccine candidate

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Trevena's scientists present research data on GPCR biased ligands at two scientific conferences

NeoPharm first-quarter net loss decreases to $1.4 million

Cook Medical files for PMA of Zilver PTX Drug-Eluting Peripheral Stent with FDA

Otonomy completes $10 million Series A financing with Avalon Ventures

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

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