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US FDA Approves IND for Bacteriophage Treatment of Patients with Resistant Infections of the Urinary Tract

The US FDA approved an IND application prepared and submitted by Amarex for their client Adaptive Phage Therapeutics, Inc. (APT).

03 April 2020
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Amarex Executes Three Rush COVID-19 Related Submissions to the FDA in March for Expedited Approval of: 1) Diagnostic, 2) Device, 3) Therapeutic

On March 27, Amarex executed a rush submission to the US FDA of an Emergency Use Authorization (EAU) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2).

30 March 2020
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Upcoming Webinar

Upgrading the FDA Adverse Event Reporting System (FAERS) Based on International Council for Harmonisation (ICH) E2B (R3) Standards | April 7, 2020 11:00 AM EDT

27 March 2020
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Amarex Assists with Emergency Use Authorization (EUA) for COVID-19 Treatment

[We] worked with client CytoDyn to prepare, submit and achieve FDA approval for an EUA for CytoDyn’s leronlimab, a monoclonal antibody product, as a potential treatment for coronavirus disease 2019 (COVID-19).

20 March 2020

As a full-service, international CRO, Amarex Clinical Research has extensive experience successfully performing clinical studies across all phases of research and discovery, development, validation and approval.​​​

Recommended by the people who matter most: our clients.

 

Chief Medical Officer 

A Maryland Biotech Company

We have worked with Amarex on numerous projects and they consistently deliver high quality reliable service by leveraging a broad array of clinical and regulatory expertise. What sets them apart from other CROs is a creative entrepreneurial approach to drug development. They go beyond the technical aspects of clinical trial development and work with the sponsor to drive value and increase chances for success.

        

             5/5

Chief Technical Officer

A Canadian-based Infectious Diseases Organization

[Thank you to the team at Amarex] for the statistical support which proved to be invaluable and completely accurate in the final review by FDA. The cornerstone of this milestone achievement was the data from the clinical study, including the limit of detection study, and we came through [all FDA reviews with solid outcomes throughout]. From all of us here, a sincere thank you and well done to all at Amarex who worked on this project. We look forward to working with you again as we apply the successful platform to other diagnostic device developments in the future.

        

             5/5

VP, Clinical Development

A Canadian Device Company

To this focused and hard-working team: I count myself lucky to work with such caring individuals.Thanks for being some of the most interesting and high performing people I've ever worked with.

        

             5/5

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