Articles Published in 2011

Pfizer signs precision medicine research agreement with Medco

Thursday, October 27, 2011 01:41 PM

Pfizer has established a research collaboration with Medco Health Solutions and its wholly owned subsidiary, United BioSource Corporation (UBC), aimed at more effectively matching patients with treatments that will benefit them the most, thereby improving patient outcomes.

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FDA awards $2 million to support CERSI

Thursday, October 27, 2011 01:23 PM

The FDA has reported the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI).

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Parexel expands commercialization services

Thursday, October 27, 2011 01:14 PM

Parexel International has expanded its capabilities to provide biopharmaceutical companies with dedicated support for their commercialization goals.  PAREXEL has fully integrated its commercialization services to help clients maximize regional and global market access opportunities. These solutions align reimbursement strategies with clinical development to gather the precise data required to demonstrate product value.

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Moffitt, The US Oncology Network advance cancer patient services

Thursday, October 27, 2011 12:57 PM

Moffitt Cancer Center,  the only National Cancer Institute(NCI) Comprehensive Cancer Center in Florida, and The US Oncology Network will work together to expand access to patient services in Florida. As part of both organizations’ long-term commitment to advancing the quality and science of cancer care, the two are collaborating to develop and operate community-based cancer centers throughout the state.

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Bristol-Myers, Gilead ink licensing agreement for HIV medicines

Thursday, October 27, 2011 12:41 PM

Bristol-Myers Squibb and Gilead Sciences have signed a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb's protease inhibitor REYATAZ (atazanavir sulfate) and Gilead's cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing. Gilead is currently studying atazanavir and cobicistat in phase II and III studies in HIV-1 treatment-naive patients.

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Theorem names VP, global business development

Thursday, October 27, 2011 12:22 PM

Theorem Clinical Research, previously Omnicare Clinical Research, has named Adam Serody vice president, global business development. In his new role, Serody will lead Theorem’s global sales, proposals and marketing organizations.

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Cmed launches Timaeus GTB to speed study setup

Thursday, October 27, 2011 11:55 AM

Cmed Technology has launched Timaeus Guided Trial Builder (GTB), a new product that introduces an entirely different approach to reduce the time and effort required to start up electronic trials. GTB builds on a decade of real-world experience managing trials in Cmed’s CRO division. GTB enables study teams to speed up and simplify Study Setup—without sacrificing flexibility, quality or adherence to best practices.

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Bionovo initiates enrollment for phase III Menerba trial

Thursday, October 27, 2011 11:34 AM

Bionovo has started enrollment for the phase III pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.

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Dietz joins Galleon Pharmaceuticals

Thursday, October 27, 2011 11:17 AM

Galleon Pharmaceuticals has named Thomas J. Dietz, Ph.D., chairman. Dietz is chairman and CEO of Waypoint Holdings, a financial-holdings and services company.

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FDA, ADVENTRX reach agreement for ANX-514 trial

Thursday, October 27, 2011 11:03 AM

ADVENTRX Pharmaceuticals met with the FDA to discuss a single clinical study to support approval of ANX-514 (docetaxel for injectable emulsion), a detergent-free reformulation of Taxotere.

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December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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