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.

COVID-19 News & Events

Aug 25, 2020

Amarex 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.

Aug 20, 2020

Amarex announced 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.

Jun 01, 2020

In April, Amarex 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.

May 27, 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. Initial results appear to show that leronlimab restores immune homeostasis, reduces plasma viral load, and reverses hyperimmune activation and inflammation in critically ill COVID-19 patients.

May 21, 2020

Yesterday, Amarex 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. Amarex’s Regulatory Affairs team prepared and submitted the application within one week of receiving the request from the client. An approval from Belgium authorities is expected soon.

May 18, 2020

Amarex 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.

May 14, 2020

On May 11, Amarex 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). The product, 1copyTM COVID-19 qPCR Multi Kit, is a highly sensitive assay with a short test result time of less than two hours. Developed by 1drop Inc., a Korea-based biotechnology company, this product is already approved in several countries, including South Korea, Sri Lanka, Germany, Luxemburg, Paraguay, Georgia, Bulgaria and Canada.

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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. 

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.

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.

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.

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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