Amarex is assisting a number of companies obtain Emergency Use Authorization and rapidly approved clinical trials from the U.S. FDA for drug, vaccine, device, and diagnostic products that are intended to treat or diagnose COVID. Please see some of our latest activities below... How can we help you?

This page will be updated frequently with new information.

LATEST ANNOUNCEMENT:

Amarex in the Fight Against COVID-19

In early March, we began work on a potential treatment for Coronavirus Disease 2019. Since then, we have helped 16 companies on 32 separate projects for COVID-19 products.

Amarex COVID-19 Activities

Amarex Clinical Research, LLC, an NSF International company, announced today their client’s Phase 3 clinical trial for patients with severe-to-critical COVID-19 symptoms has reached the patient enrollment halfway point. Amarex’s team has managed the trial and will conduct the interim analysis.

Wednesday, August 26, 2020

Announcing the completion of a Phase 2, randomized, double-blind, placebo-controlled clinical study evaluating efficacy and safety of PRO 140 (leronlimab) in patients with documented COVID-19 symptoms.

Friday, August 21, 2020

The just released Issue 47 of NSF International’s Health Science Journal features contributions by Amarex Clinical Research, LLC, an NSF Internaional company. 

Thursday, August 06, 2020

Learn more about this product approval here. 

Thursday, June 25, 2020

In April, Amarex Clinical Research, LLC, an NSF International company, 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.

Thursday, June 02, 2020

In mid-March, Amarex worked with client CytoDyn to prepare, submit, and achieve FDA approval for emergency use of CytoDyn’s drug leronlimab as a treatment for severe cases of COVID-19. Since then, over 50 patients in a New York hospital have been treated with leronlimab.

Thursday, May 28, 2020

On Thursday, May 22, 2020, Amarex Clinical Research, LLC, an NSF International company, 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 COVID-19 disease in a special patient population.

Friday, May 22, 2020

Amarex Clinical Research, LLC, an NSF International company, 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.

Tuesday, May 19, 2020

On May 11, Amarex Clinical Research, LLC, an NSF Interational company 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). 

Friday, May 15, 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.

Tuesday, May 12, 2020

Amarex achieved approval from the UK health authorities to conduct a Phase 2 clinical trial of a recombinant human protein product, on behalf of its client, as a treatment for a subpopulation of patient with COVID-19. 

Thursday, May 07, 2020

Amarex received a Safe to Proceed letter from the U.S. FDA to conduct a Phase 2b/3 clinical trial for severely ill COVID-19 patients. The Safe to Proceed letter came after considerable communication with the FDA.

Thursday, April 23, 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.

Monday, March 30, 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.

Friday, March 20, 2020

Webinar Recording: Amarex in the Fight Against COVID-19  

Dr. Kazem Kazempour, President & CEO of Amarex Clinical Research, LLC, an NSF International company presented a webinar highlighting Amarex’s COVID-19 work. Dr. Kazempour also discusses clinical trial regulatory activities around the globe, non-COVID-19 clinical trial activities, and emergency use authorizations (EUAs) for IVDs (including but not exclusive to COVID-19 trials).

 

View the webinar recording here.

 

Since March, Amarex has helped numerous companies with COVID-19 clinical product development (including device, diagnostic, drug, biologic, and vaccine products). Additionally, Amarex’s Regulatory department has executed applications and requests for compassionate use, emergency use, EUA, Clinical Trial Agreement, preIND meeting, eIND, fast track designation, and expanded access in the U.S., UK, Europe, and Asia.  

 

TFDA Seminar Recording: FDA Approval Process for Digital Health Devices and EUA’s  

The TFDA Seminar recordings are available here.

On June 22, 2020, Dr. Kazem Kazempour, President & CEO, and Dr. Chia-Hua Maggie Ho, COO, of Amarex Taiwan, LLC gave a seminar to the Taiwan Food and Drug Administration (TFDA) titled U.S. FDA Approval Process for Digital Health Devices and Emergency Use Authorizations.

 

Topics discussed include regulatory strategy and clinical evaluation required for market approval of software and AI-related medical products, current international medical software regulation and risk management of AI medical products, and clinical evaluation of software as medical device. The seminar also covers explaination of FDA general recommendations and procedures applicable to the authorization of the emergency use of COVID-19 diagnostic devices.

Webinar Recording Available: Trial Design in General & Adaptive Trials in Particular

The full recording of our complimentary webinar, reviewing clinical trial design, is available here.

This webinar is presented by Amarex President & CEO, Dr. Kazem Kazempour. He addresses aspects of before study and after study clinical trial design. Physicians focus groups, KOL thoughts, selecting endpoints, IP management and distribution, site selection and patient recruitment are discussed. This webinar focuses specifically on the advantages and disadvantages of adapting a clinical trial.

Webinar Recording Available: Emergency Market Authorization of COVID-19 IVDs

This full recording of our complimentary webinar, reviewing insights into the Emergency Market Authorization of COVID-19 IVDs, is available here.

This webinar covers emergency authorization applications for the E.U., the U.S., Asia, Australia and the World Health Organization

Webinar Recording Available: Upgrading FAERS Based on ICH E2B (R3) Standards

This free webinar addresses the US FDA’s plan to modernize electronic submission standards for drug, biological and drug/biologic-led combination products for the premarket and post market safety surveillance programs. The webinar summarizes upgrades to electronic submission of Individual Case Safety Reports (ICRs) in the FDA Adverse Event Reporting System (FAERS) using ICH E2B(R3) standards that are disclosed to the public, FAERSII’s implementation timeline, benefits and impacts on stakeholders and industry. 

This webinar includes a special focus on upgrading FAERS during the COVID-19 pandemic.

View the full recording of this webinar here.

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