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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:

Severe-to-Critical COVID-19 Patient Clinical Trial Reaches Full Enrollment

Our client’s Phase III clinical trial for patients with severe-to-critical COVID-19 symptoms reached full enrollment (390 patients) in mid-December. Data analysis results are expected this quarter. The trial was conducted in the U.S., Canada, and U.K..  

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COVID-19 News & Events

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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.

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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.

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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.

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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).

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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.

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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.”

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Dr. Kazem Kazempour, President & CEO of Amarex Taiwan, 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. 

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On June 22, 2020, Dr. Kazem Kazempour, President & CEO, Amarex Taiwan, LLC 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. Video recordings from the seminar are available for viewing. Topic summaries:

Software as medical device (SaMD) is broadly defined as software intended to be used for one or more medical purposes, without being part of a hardware medical device. SaMD products vary in use and complexity, including image-reading software that runs on a smartphone to advanced artificial intelligence (AI) such as machine learning algorithms. This course introduces 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 are discussed.

During the COVID-19 pandemic, the FDA can use its emergency use authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent COVID-19 when certain criteria are met, including that there are no adequate, approved, and available alternatives. This training course explains FDA general recommendations and procedures applicable to the authorization of the emergency use of COVID-19 diagnostic devices.

View the course recordings on our YouTube channel.

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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.

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

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

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

Learn from industry experts:

  • Robyn Meurant, Executive Director at NSF International. Before joining NSF, Robyn acted both as a professional officer and an advisor to the WHO and assisted with the development of the EUL for IVDs.

  • Chia-hua Maggie Ho, D. Phil., COO of Amarex Clinical Research, LLC, an NSF International Company. Dr. Ho specializes in APAC regulatory submission, clinical operations, business development and client services for the Pan-Pacific region.

View the full webinar here.

Contact our experts, Robyn Murant, at rmeurant@nsf.org, and Chia-hua Maggie Ho, at maggieh@amarextw.com, or get in touch with our Business Development team.

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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.