Articles Published in 2007

Type II Diabetes Drug Fails Primary Endpoint

Tuesday, July 24, 2007 07:13 AM

Metabasis and Daiichi Sankyo issued negative results from a phase IIb trial of CS-917 for the treatment of type II diabetes. This multi-center, double-blind, placebo-controlled trial enrolled 392 subjects who were divided into four treatment arms to receive CS-917 at 50 mg BID or 100 mg BID, metformin at 850 mg BID or placebo, for three months. 

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WIRB Copernicus Group

Kendle Raises $200 Million Through Convertible Senior Note Offering

Monday, July 23, 2007 04:50 PM

Cincinnati, Ohio-based Kendle International has closed a $200 million offering of convertible senior notes, which would become due in 2012. The notes would be converted into a combination of cash and common stock.

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CRF Health eCOA webinar series

Fraudulent Study Broker Cherie Thibodeau Continues to Bilk Sites

Friday, July 20, 2007 03:45 PM

As a public service to sites, CROs and biopharmaceutical companies, CenterWatch is posting a long excerpt of this week’s CWWeekly article about fraudulent study broker, Cherie Thibodeau.

If you have been defrauded of funds by Cherie Thibodeau, please contact CenterWatch at editorial@centerwatch.com.

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Top Stories for the Week of July 16th 2007

Friday, July 20, 2007 12:08 PM

Top News

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India to Allow First-in-Human Phase I Studies of Molecules Developed Abroad Soon?

Thursday, July 19, 2007 07:15 AM

India may allow first-in-human phase I studies of molecules developed abroad in the near future. Currently, India only allows first-in-human studies developed in India—a boon to the burgeoning domestic clinical research industry, and a bane of the global clinical research industry.

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Recent Industry Personnel News

Wednesday, July 18, 2007 03:58 PM
  • London-based CRO Premier Research Group hired David Fitts, MPH, Ph.D as executive director, biostatistics. Fitts comes to Premier from EMD Pharmaceutical, part of German-based Merck KGaA, where he was vice president of the clinical R&D unit’s global biostatistics and data services group. Fitts will now be responsible for all of Premier biostatistics operations in the U.S.

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CenterWatch Monthly: July 2007 Issue

Tuesday, July 17, 2007 08:38 AM

Radiant Research Leads Global Change in Site Management Market

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DepoMed Sees Negative Results from Controlled-Release Gabapentin

Monday, July 16, 2007 02:31 PM

DepoMed reported negative results from a phase III trial of Gabapentin GR for the treatment of postherpetic neuralgia (PHN). The product is a twice-daily, controlled-release tablet formulation of the anticonvulsant and analgesic gabapentin.

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Encorium Group Scores $1.7 million Phase II Contract

Monday, July 16, 2007 07:30 AM

Wayne, Pa.-based CRO Encorium Group has inked a $1.7 million deal to manage a phase II trial in major depressive disorder for an unnamed biotech company based in Japan. Encorium will provide site management and monitoring, data management, biostatistical support and medical writing for the study. Encorium stated it intends to pursue further opportunities in the Japanese market and has made that market one of its key long-term business strategies. Recently, the company signed a $3.8 million contract to conduct phase IIb clinical trials with a new antiviral agent for the treatment of shingles (herpes zoster).

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Top Stories for the Week of July 9th 2007

Friday, July 13, 2007 01:38 PM

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July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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June

CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

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