Clinical Trial News and Research

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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

PAREXEL experts to present on biopharmaceutical industry issues at 46th DIA

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that several of its experts will present on important industry issues at the Drug Information Association (DIA) 46th Annual Meeting, being held from June 13 – 17, 2010 in Washington, DC.

From Parexel 10 Jun 2010

Neutralizing inhibitory molecules does not improve regeneration in damaged spinal axons

Neuroscientists at the University of California, San Diego School of Medicine have found that removing three key inhibitory molecules from myelin - the insulating material that surrounds nerve cell fibers - does not significantly boost the ability of injured spinal axons to regenerate and restore themselves to full function.

10 Jun 2010

Spectranetics plans multi-center, randomized clinical trial program for in-stent restenosis

The Spectranetics Corporation today announced its clinical trial plans related to the treatment of in-stent restenosis (ISR) in arteries above the knee, which remains a major unsolved medical problem. There is no device currently cleared or approved by the FDA to treat ISR.

10 Jun 2010

Baylor Institute of Immunology Research receives nearly $35M as grants in 2009

Even in an economy that's proved devastating to charitable giving and government grants, the Baylor Institute of Immunology Research (BIIR), a component of Baylor Research Institute (BRI), has managed to buck the trend: BIIR received grants totaling nearly $35 million in 2009.

10 Jun 2010

Clarient becomes preferred genetic testing lab for Generation Health

Clarient, Inc., a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced a new contractual agreement with Generation Health, Inc. (GH). This agreement makes Clarient a preferred genetic testing lab for GH, thereby ensuring reimbursement of diagnostic tests done for GH's nationwide network of payor clients and expanding Clarient's potential market. GH is a genetic benefit management company partially-owned by CVS Caremark, the nation's largest pharmacy healthcare provider.

10 Jun 2010

Updated clinical data from SNSS's Phase 2 clinical trial of voreloxin

MicroStockProfit.com announces an investment report featuring Sunesis Pharmaceuticals Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

10 Jun 2010

Cognitive-behavioral, skills-based treatment intervention program shows promise for teenagers with IBD

Disease is a private matter to many of us. For many reasons, we want to keep it to ourselves, and no cluster of disorders challenges patients' need for privacy more than inflammatory bowel disease.

10 Jun 2010

Free education program highlights advancements in treatment of blood cancers, importance of clinical trials

The John Theurer Cancer Center at Hackensack University Medical Center and The Leukemia & Lymphoma Society have come together to host Partners in Progress: An Expert Panel Discussion on Advancing Therapies for Blood Cancers on Tuesday, June 22 in Hackensack, NJ. This free educational program is for patients, caregivers, and healthcare providers.

10 Jun 2010

PHT, Entra Health partner to provide integrated data monitoring technology for clinical trials in diabetes

PHT Corporation, the leading provider of electronic patient reported outcome (ePRO) solutions today announced a strategic partnership with Entra Health Systems, an international applied healthcare technology company. Together PHT and Entra Health will provide integrated data monitoring technology for the management of clinical trials for the treatment of diabetes and in trials where blood glucose management plays a critical role in the investigation.

10 Jun 2010

Veracyte announces completion of Series B round

Veracyte, Inc. announced today the successful completion of its Series B round, a key milestone toward the company's first product launch later this year. The South San Francisco biotechnology company is committed to pioneering molecular cytology diagnostics to improve patient care and lower health care costs. This round was led by Domain Associates with significant participation from Veracyte's founding investors including Kleiner Perkins Caufield & Byers (KPCB), TPG Biotech (TPG), and Versant Ventures.

10 Jun 2010

Clinical Trial News and Research

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

PAREXEL experts to present on biopharmaceutical industry issues at 46th DIA

Neutralizing inhibitory molecules does not improve regeneration in damaged spinal axons

Spectranetics plans multi-center, randomized clinical trial program for in-stent restenosis

Baylor Institute of Immunology Research receives nearly $35M as grants in 2009

Clarient becomes preferred genetic testing lab for Generation Health

Updated clinical data from SNSS's Phase 2 clinical trial of voreloxin

Cognitive-behavioral, skills-based treatment intervention program shows promise for teenagers with IBD

Free education program highlights advancements in treatment of blood cancers, importance of clinical trials

PHT, Entra Health partner to provide integrated data monitoring technology for clinical trials in diabetes

Veracyte announces completion of Series B round

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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