Articles Published in 2008

CWWeekly March 10th 2008 Issue

Friday, March 14, 2008 10:30 AM

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Japan's New Regulatory Attitude Evident at DIA EuroMeeting

Wednesday, March 12, 2008 11:49 AM

One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who  was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.

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RLS Drug Shows Promise in Pivotal Trial

Tuesday, March 11, 2008 02:04 PM

XenoPort and GlaxoSmithKline reported positive top-line results from a phase III trial of XP13512, a gabapentin pro-drug with enhanced absorption, for the treatment of moderate to severe restless legs syndrome. This 12-week, double-blind, placebo-controlled study, dubbed XP053, enrolled 325 subjects. The endpoints were met with statistical significance in both dose groups when compared to placebo.

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etrials' Reports $2.6M Loss

Monday, March 10, 2008 12:31 PM

Morrisville, N.C.-based etrials’ sales were up 17% during its 2007 fourth quarter. The eClinical company reported net service revenue was $4.9 million compared with $4.2 million in 2006. However, it reported a net loss for the fourth quarter of $2.6 million (or $0.24 per diluted share) compared with a net loss of $46,000 (or $0.00 per diluted share) in the fourth quarter of 2006.

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CWWeekly March 3rd 2008 Issue

Friday, March 7, 2008 11:10 AM

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EDICT Project Opens Policy Recommendations For Public Comment

Thursday, March 6, 2008 08:20 AM

The EDICT project, short for Eliminating Disparities in Clinical Trials, has invited the public to comment on a series of policy proposals design to help patient recruitment and retention in clinical trials. The period open to public comment runs until March 21.

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AbCRO Opens Two Offices in Russia

Tuesday, March 4, 2008 09:46 AM

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened two offices in Russia.

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CWWeekly January 25th 2008 Issue

Monday, March 3, 2008 10:05 AM

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PharmaNet 2008 Outlook Cut Amid Strong CRO Growth

Friday, February 29, 2008 12:22 PM

Contract research organizations (CROs) had a great run in the past year, but PharmaNet Development Group’s weak guidance for 2008, issued on Feb. 28, sent its shares tumbling more than 30%. That raises concerns about a possible pullback for the clinical trials industry following a strong year.

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GVAX Show Antibody Respone in Prostate Cancer

Wednesday, February 27, 2008 01:34 PM

Cell Genesys reported positive results from a phase II trial of GVAX for the treatment of prostate cancer. GVAX is a cell vaccine that is also being evaluated for the treatment of leukemia and pancreatic cancer.  The autologous vaccine is made by removing a sample of the patient's own tumor and coaxing it into producing granulocyte-macrophage colony stimulating factor (GM-CSF). The vaccine is then re-administered into the patient via injection, which initiates a potent immune response against the tumor.

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