Media / News Releases

May 21, 2020

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 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.

May 14, 2020

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.

May 11, 2020

On May 11, the U.S. FDA updated the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. In the revised policy, the U.S. FDA recommends that all diagnostic manufacturers and testing labs conduct their SARS-CoV-2 assay validation using SARS-CoV-2 positive and negative clinical specimens (30 positives/30 negatives), in preference to the previously accepted ‘contrived’ test specimens.

May 06, 2020

Amarex achieved approval from the UK health authorities ((Medicines and Healthcare products Regulatory Agency (MHRA) as well as central ethical committee, “Health Research Authority (HRA)”) to conduct a Phase 2 clinical trial of a recombinant human protein product, on behalf of its client, as a treatment for a sub-population of patients with COVID-19. This Clinical Trial Application (CTA) was prepared and submitted to MHRA by Amarex’s Regulatory Affairs department within a very short period of time. Patient enrollment is targeted to begin next week, and Amarex will be managing the study for the client.

Apr 22, 2020

Amarex received a Safe to Proceed letter from the U.S. FDA to conduct a Phase 2b/3 clinical trial of CytoDyn’s product leronlimab (PRO 140) as a treatment for severely ill COVID-19 patients. The Safe to Proceed letter came after considerable communication with the FDA.

Apr 15, 2020

Amarex is helping organizations prepare and submit Emergency Use Authorizations (EUAs) and expanded access, also called “compassionate use”, requests for U.S. FDA approval of drugs, medical devices and IVD kits to treat and diagnose the coronavirus disease 2019 (COVID-19).

Apr 02, 2020

Amarex announces that the US Food and Drug Administration approved an IND application prepared and submitted by Amarex for their client Adaptive Phage Therapeutics, Inc. (APT). This allows APT to proceed with their Phase I/II study of a personalized bacteriophage therapeutic for the treatment of patients with multi-drug resistant (MDR) pathogenic bacteria and other complicated infections. This study helps APT expand their growing library of hundreds of bacteriophage (PhageBankTM) which kill the six highest priority MDR pathogenic bacteria.

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