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

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.  

Amarex COVID-19 Activities

Thursday, May 28, 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.

Friday, May 22, 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 the COVID-19 disease in a special patient population.

Tuesday, May 19, 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.

Friday, May 15, 2020

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

Tuesday, May 12, 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.

Thursday, May 07, 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, April 23, 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.

Monday, March 30, 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.

Friday, March 20, 20202

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.
Free Webinar: Pros and Cons of Adaptive Clinical Trial Design
June 16, 2020

The defining characteristic of all adaptive designs is modification of an ongoing clinical trial, based on data from interim analyses, in accordance with predetermined rules, while maintaining trial integrity and validity. Adaptive designs are complex, but with expert biostatistical knowledge, challenges and complexities can be overcome. This webinar reviews the advantages and disadvantages of adapting a clinical trial. Practical limitations to adaptive trials, and knowing when not to adapt, will be covered, along with discussion of the major benefits of adapting, including better utilization of resources and greater flexibility in clinical trials.

This complimentary webinar will be presented by Amarex President and CEO, Dr. Kazem Kazempour. He will also review relevant issues related to the COVID-19 pandemic.

 

Register for this webinar here.

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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