Articles Published in 2011

Marken launches SOLO to manage clinical trials distribution

Wednesday, December 7, 2011 12:53 PM

Marken has launched Solo, their proprietary web based system used to manage the regulatory, inventory and operational supply chain complexities of clinical trials. The system, which has been developed exclusively for Marken, is designed to manage all aspects of Marken’s global depot network including: receipt of clinical supplies and kits, dispatches, returns, warehouse movements and QA releases. Solo is a secure, validated, web-based system which is fully accessible to Marken’s clients on a 24/7 basis from any location in the world. Marken has designed Solo to integrate with multiple client-directed IXR (Interactive Reporting) systems.

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Zalicus initiates phase I Z160 trial

Wednesday, December 7, 2011 12:31 PM

Zalicus has initiated a phase I clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160 (formerly NMED-160), a novel oral N-type calcium channel blocker. Z160 has been reformulated with multiple state-of-the-art delivery techniques to address previous solubility and bioavailability issues. Zalicus plans to run phase I human pharmacokinetic and safety studies with these formulations during the remainder of 2011 and into early 2012. Based on this pharmacokinetic and safety data, Zalicus plans to select the best formulation to advance into phase II clinical development in 2012. A previous formulation of Z160 has been studied in clinical trials of over 200 subjects and was well tolerated.

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HighQ partners with SAFE-BioPharma

Wednesday, December 7, 2011 12:23 PM

London-based HighQ has formed a vendor partnership with the SAFE-BioPharma Association. Companies within the global pharmaceutical and biotechnology industry use the SAFE-BioPharma standard in FDA Title 21 CFR part 11 compliant processes for signing SOPs, quality and compliance documentation, research and development documentation, corporate compliance documents and more.

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Essentialis names Berg CEO

Wednesday, December 7, 2011 10:31 AM

Essentialis has promoted Aaron D. Berg from president and chief commercial officer to chief executive officer. Berg joined Essentialis in 2010 bringing business development and product commercialization experience to the company. He was also appointed to the Essentialis board of directors.

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Almac launches COMPASS platform to improve clinical trial management

Wednesday, December 7, 2011 10:21 AM

Almac has launched of its new forecasting platform, COMPASS, which has been designed to improve the accuracy and efficiency of the supply inventory process during clinical studies. COMPASS provides benefits to clients by allowing the Supply Chain Manager to proactively direct the entire clinical supply chain, ultimately saving money that is often lost through inaccurate forecasting or overproduction of supplies.  

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Curemark's phase III autism trial shows positive results

Wednesday, December 7, 2011 10:08 AM

Curemark has reported its phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for autism met its primary and secondary endpoints. The trial compared CM-AT to placebo in children with autism aged 3-8. Top line results demonstrate a statistically significant effect of CM-AT over placebo on both core and non-core symptoms of autism.

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Aratana Therapeutics raises $15m in Series B financing

Wednesday, December 7, 2011 10:01 AM

Aratana Therapeutics has closed a $15 million Series B financing, bringing the total capital raised since Aratana was launched earlier this year to $31 million.

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Theraclone names Stocks CEO

Tuesday, December 6, 2011 02:41 PM

Theraclone Sciences has named Clifford J. Stocks chief executive officer.

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Samsung, Biogen establish $300m partnership in biosimilar development

Tuesday, December 6, 2011 02:25 PM

Samsung and Biogen Idec have entered into an agreement to invest $300 million to establish a joint venture to develop, manufacture and market biosimilars. Samsung will take a leading role in the joint venture, with Biogen Idec contributing in protein engineering and biologics manufacturing.

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Researchers use stem cells to determine new therapies for severe childhood epilepsy

Tuesday, December 6, 2011 01:52 PM

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