台灣安美睿致力於支持針對新型冠狀病毒之臨床試驗。我們的專家團隊正在不懈努力以加快流程並幫助客戶應對這種不斷變化發展的全球大流行疾病。我們目前正在與全世界各地的眾多客戶合作,以加速其病毒診斷、醫療器材、和治療產品的上市時程。

此頁面將會頻繁更新最新消息。

最新公告:

祝賀我們的客戶Akili Interactive之產品最近獲得美國食品藥品監督管理局(FDA)的上市許可!

在此連結了解有關獲得上市許可產品的更多信息。

新型冠狀病毒 新聞發布 | 活動

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.

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.

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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.

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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