New U.S. FDA Testing Guidance for COVID-19 Detection Assays as of May 11, 2020

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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.

The UK Health Authorities Approve COVID-19 Clinical Trial to Treat Immunocompromised Patients

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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.

COVID-19 Drug, Diagnostic and PPE Product Emergency Use Authorization (EUA) Services

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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).

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

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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.

TFDA Approves IND Application for an Amarex Client Treating Pancreatic Cancer

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​Amarex Taiwan, LLC announces that the Taiwan Food and Drug Administration (TFDA) approved an IND application for an Amarex client to proceed with their Phase I/IIa study of a new chemical entity (NCE) in the treatment of patients with pancreatic cancer. Pancreatic cancer is a deadly cancer with a high unmet medical need and preliminary nonclinical data shows potential efficacy and safety of the new chemical entity in the treatment of pancreatic cancer.