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Media / News Releases

Aug 05, 2020

Amarex Highlighted in NSF International’s Latest Health Sciences Journal

The just released Issue 47 of NSF International’s Health Science Journal features contributions by Amarex Clinical Research, LLC: 1) a white paper on Safety Risk Management; 2) an interview with visiting trainee from the Korean Ministry of Food and Drug Safety (MFDS); and 3) an overview of Amarex’s work on clinical products dealing with COVID-19 disease.

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Jun 01, 2020

Amarex Client Now Enrolling Patients for a Blood Filtration Device Study Treating COVID-19 Patients Experiencing Septic Shock

In April, Amarex achieved rapid, supplemental Investigation Device Exemption (IDE) approval from the U.S. FDA, on behalf of its client, to treat COVID-19 patients experiencing septic shock under an already underway Phase III clinical trial of a blood filtration device.

May 21, 2020

Amarex Submits a CTA to Belgium Health Authorities for a COVID-19 Clinical Trial

​Yesterday, Amarex on behalf of a client, submitted a Clinical Trial Application (CTA) to Belgium health authorities. The CTA is for a therapeutic product to treat serious side-effects of the COVID-19 disease in a special patient population. Amarex’s Regulatory Affairs team prepared and submitted the application within one week of receiving the request from the client. An approval from Belgium authorities is expected soon.

May 18, 2020

Amarex Accelerated COVID-19 Product Authorization/Approval Services

Amarex is an expert at streamlining regulatory and clinical trial testing services for product development and FDA approval. We are applying additional resources to rush timelines for all COVID-19 product projects.

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May 14, 2020

Amarex Achieves U.S. FDA EUA Approval for Client’s IVD for the Detection of SARS-CoV-2 Virus

On May 11, Amarex achieved approval from the U.S. FDA on behalf of its client, 1drop Inc., for an emergency use authorization (EUA) of an in-vitro diagnostic for the detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). The product, 1copyTM COVID-19 qPCR Multi Kit, is a highly sensitive assay with a short test result time of less than two hours. Developed by 1drop Inc., a Korea-based biotechnology company, this product is already approved in several countries, including South Korea, Sri Lanka, Germany, Luxemburg, Paraguay, Georgia, Bulgaria and Canada.

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