Media / News Releases

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Amarex Clinical Research Announces Successful Orphan Drug Designation Request Filing

Amarex is pleased to announce that it recently received notification from the U.S. Food and Drug Administration (FDA) that an orphan drug designation request, which it filed on behalf of CytoDyn Inc, has been granted.

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Amarex Clinical Research Joining MC East Asia Business Expansion Trip, October 20 – 30, 2017

Patrick Burke, Sr. Dir. of Business Development, Amarex Clinical Research will be joining the Montgomery County Economic Development Corporation of Maryland on an East Asia Business Expansion Trip to Seoul and Daejeon Metropolitan City in Korea, and  Xi’an and Shanghai in China, October 20th – 30th, 2017.

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Amarex Clinical Research Filed a Marketing Authorization Application in 5 EU Member States

Amarex Clinical Research prepared and submitted a Marketing Authorization Application (MAA) to 5 EU countries, through the Common European Submission Portal for a drug intended to treat an important urology indication in men.

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Amarex ranked among the Top 25 Bioscience Employers in the Greater Washington DC region by the Washington Business Journal

Amarex Clinical Research, LLC is pleased to announce that it has been ranked No.20 by the Washington Business Journal in its Top 25 Bioscience Employers. The rankings were published August 2017. Attached is the complete list of the Top 25 Bioscience Employers

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FDA accepts Marketing Application for Review from Amarex on a Rescue ICU-Related Trial

Amarex Clinical Research is working with a late stage company on a treatment for patients with an ICU-related indication. Amarex took over managing the entire trial services; regulatory, medical monitoring, patient recruitment, site finding and data management from another CRO that was experiencing difficulty in enrolling subjects into the trial. Amarex prepared and submitted the application to the FDA.

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Amarex reaches regulatory first in 2016

Amarex Clinical Research reached several regulatory first in late 2016. Amarex conducted a pre-IND meeting on behalf of our client. This meeting with the FDA did not last very long; the meeting lasted approximately 15 minutes, with 5 of those minutes used for participant introductions