Media / News Releases
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.
Mar 29, 2020
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). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea and Amarex and its client are therefore hopeful for a rapid FDA approval result.
Mar 19, 2020
In the past week Amarex 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). Amarex CEO, Dr. Kazem Kazempour, explained, “Cytodyn’s product has the potential to control the body’s hyper-immune response to coronavirus infection which contributes to life threatening side-effects of the disease.”
Feb 10, 2020
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.