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。

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最新公告:

Amarex向比利時衛生當局提交了臨床試驗申請以進行COVID-19臨床試驗

於2020年5月22日星期四,Amarex代表客戶向比利時衛生當局提交了臨床試驗申請(CTA),該CTA使用客戶的產品治療特定患者群體中COVID-19疾病之嚴重副作用。Amarex的法規事務部門在收到客戶的請求後一週內就準備並提交了申請, 預計不久就將獲得比利時當局的批准。

新型冠狀病毒 新聞發布 | 活動

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.

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).

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.

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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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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