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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

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Abraxis BioScience, Inc. presented trial design information from its ongoing phase 3 registration trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year.

11 Jun 2010

Perceptive Informatics releases new web-based version of DataLabs Designer module

Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation, today released a new web-based version of the DataLabs Designer™ module, which is part of Perceptive's DataLabs® Electronic Data Capture (EDC) solution. The web-based study design tool, which can be hosted by Perceptive, provides clinical study teams worldwide with online access to collaboratively design trials. This core capability assists in streamlining workflow and improving the efficiency of the study design process.

11 Jun 2010

New book provides overview of paediatric drug development

Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign.

11 Jun 2010

Merge Healthcare launches CIMS workflow solution for imaging in clinical trials

Merge Healthcare has combined its expertise in medical imaging and clinical trials management software to launch a complete workflow solution for imaging in clinical trials. The new CIMS solution is the first open platform in the industry that allows organizations involved in clinical trials to transparently execute the imaging portion of the study within the overall electronic trial management solution.

11 Jun 2010

Medidata extends Rave EDC platform with Targeted SDV

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today introduced Rave Targeted SDV, the newest extension to its Medidata Rave® electronic data capture (EDC) and clinical data management (CDM) solution. Rave Targeted SDV provides clinical research sponsors and contract research organizations (CROs) with an auditable and scalable partial source document verification (SDV) solution that supports risk-based site monitoring strategies.

11 Jun 2010

Phase 3 AVERROES clinical trial of apixaban for atrial fibrillation closes early due to clear evidence of efficacy

Bristol-Myers Squibb Company and Pfizer today announced that the companies have agreed to stop the Phase 3 AVERROES clinical trial of apixaban in patients with atrial fibrillation. The study will be stopped early because a predefined interim analysis by the independent Data Monitoring Committee (DMC) revealed clear evidence of a clinically important reduction in stroke and systemic embolism in patients with atrial fibrillation considered intolerant of or unsuitable for vitamin K antagonist therapy who received apixaban as compared to aspirin.

11 Jun 2010

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval.

11 Jun 2010

Chiltern CRO announces launch of Collaborative Technologies

Chiltern International Limited (Chiltern), a global contract research organization (CRO), announced the launch of Collaborative Technologies.

10 Jun 2010

Formedix's design tools integrated with Nextrials' EDC and clinical trial data management platform

Nextrials, Inc., a leader in clinical research software and services, today announced that its electronic data capture (EDC) and clinical trial data management platform, Prism™, is now integrated with the study design tools offered by Formedix. Formedix's industry leading Origin™ products include database design tools based on the data standards developed by the Clinical Data Interchange Standards Consortium (CDISC), a platform that Nextrials fully supports.

10 Jun 2010

Idenix initiates IDX320 proof-of-concept study for HCV infection

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has initiated a 3-day proof-of-concept study of IDX320, a protease inhibitor for the treatment of hepatitis C virus (HCV) infection, under a Clinical Trial Application (CTA). The study is evaluating IDX320 in treatment-naive hepatitis C genotype 1-infected patients.

10 Jun 2010

Clinical Trial News and Research

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

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Perceptive Informatics releases new web-based version of DataLabs Designer module

New book provides overview of paediatric drug development

Merge Healthcare launches CIMS workflow solution for imaging in clinical trials

Medidata extends Rave EDC platform with Targeted SDV

Phase 3 AVERROES clinical trial of apixaban for atrial fibrillation closes early due to clear evidence of efficacy

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Chiltern CRO announces launch of Collaborative Technologies

Formedix's design tools integrated with Nextrials' EDC and clinical trial data management platform

Idenix initiates IDX320 proof-of-concept study for HCV infection

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