Latest News

• US FDA Authorizes Launch of Clinical Trial to Support New Treatment Development for Progeria

  September 30, 2024

  New Trial to Study Progerinin Treatment for Ultra-Rare Condition

• Amarex Achieves Orphan Drug Designation for Gibson Oncology’s Novel LMP744 Cancer Treatment

  September 24, 2024

  New Designation Marks Milestone in Glioblastoma Treatment Decades in the Making with Glioma Treatment that Crosses Blood Brain Barrier at Ten Times Concentration Needed to Kill Cancer Cells

• Amarex Clinical Research to Manage Phase 2 Clinical Study of a New Therapy for COVID-19 Long-Haulers

  September 10, 2021

• Amarex Featured in 15-year Anniversary Issue of the NSF Journal

  February 24, 2021

  The just released Issue 48 of NSF International’s Health Science Journal features contributions by Amarex Clinical Research, LLC.

• Amarex to Support AIM ImmunoTech in Regulatory Filings for Exciting Pancreatic Cancer Treatment Under Development

  September 22, 2020

  Amarex today announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus Medical Center in the Netherlands.

• Amarex Highlighted in NSF’s Latest Health Sciences Journal

  August 6, 2020

  The just released Issue 47 of NSF International’s Health Science Journal features contributions by Amarex Clinical Research, LLC: 1) a white paper on Safety Risk Management, 2) an interview with visiting trainee from the Korean Ministry of Food and Drug Safety (MFDS); and 3) an overview of Amarex’s work on clinical products dealing with COVID-19 disease.

• Amarex Accelerated COVID-19 Product Authorization/Approval Services

  May 19, 2020

  We are experts at streamlining regulatory and clinical trial testing services for product development and FDA approval, and we are applying additional resources to rush timelines for all COVID-19 product projects.

• COVID-19 Drug, Diagnostic and PPE Product Emergency Use Authorization (EUA) Services

  April 16, 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).

• 2019 Regulatory Affairs Year in Review

  January 28, 2020

  Our Regulatory Affairs Department Offers a competitive Regulatory Strategy to Clients and Maintains Successful Interactions with the US FDA and Foreign Regulatory Bodies.

• Follow-Up: Amarex Taiwan’s COO, Dr. Chia-Hua Maggie Ho, Keynoted at the 2019 TFDA Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries | Taipei, Taiwan

  October 1, 2019

  On September 25th, at the 2019 TFDA Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries, Amarex Taiwan COO, Dr. Chia-Hua Maggie Ho, gave a keynote presentation addressing the application of, and current US FDA regulatory trends for, AI/ML-based SaMD.

• Electronic Submissions to the U.S. FDA – The Time Has Arrived!

  August 7, 2018

  As of May 2018 the U.S. FDA requires all submissions related to regulated medical products to be made electronically through the FDA’s Electronic Submissions Gateway (ESG).

• Collaboration Between Hanbat National University (S. Korea) and Amarex Clinical Research

  January 19, 2018

  Amarex Clinical Research was pleased to welcome distinguished guests, Professor Yoon Kee Kim and Dr. Jon won Lee, from Hanbat National University as visitors to Amarex on 10 January 2018. Hanbat National University, located in Daejeon, South Korea, is one of the country’s most prominent universities.

• MCEDC Interviews Patrick J. Burke

  January 19, 2018

  Senior Director of Business Development at Amarex Clinical Research, Patrick J. Burke, met with Warren Ellis.

• Amarex Completes 505(b)(2) Product Trial in Six Months

  September 10, 2015

  Amarex recently completed a successful PIV trial for a 505(b)(2) cardiovascular product within six months of initiating trial setup activities, including completion of the statistical analysis and first draft of the clinical study report.

• FDA GCP Audit of Amarex

  January 15, 2015

  This past week, the U.S. FDA conducted a GCP audit of Amarex headquarters, and the result was 'no findings' and no '483s'.

• Amarex Enrollment Completion Ahead of Schedule for a Diabetic Neuropathy Clinical Trial

  November 12, 2014

  Amarex announced today completion of enrollment for a Diabetic Neuropathy Clinical Trial.

• Amarex Achieves Exceptionally Fast "First Patient Screened" Deadline for Two Challenging Trials

  May 27, 2014

  Amarex announced today, achievement of exceptionally fast "First Patient Screened" deadlines for two logistically challenging trials.

• Amarex Invited to Join Executive Trade Mission to India

  March 12, 2014

  Amarex has been invited by Montgomery County Executive, Isiah Leggett, to participate as an official member of the County's upcoming trade mission to India.

• Successful FDA Meeting Advances Botanical Drug to Phase II Study

  October 8, 2013

  Amarex Clinical Research recently met with the FDA on behalf of their client to propose a PII study as the next step of their clinical development program.

• Washington Business Journal Names Amarex as One of the Top 20 Bioscience Employers

  May 17, 2013

  The Washington Business Journal names Amarex as one of the top 20 bioscience employers.

• Amarex Receives Award in the Pharmaceutical Preparations Classification

  May 6, 2013

  For the second consecutive year, The Germantown Award Program has chosen Amarex Clinical Research for the 2013 Germantown Awards in the Pharmaceutical Preparations Classification.

• Amarex Client, SOBI, Receives FDA Approval for Kineret for the Treatment of NOMID

  January 11, 2013

  SOBI, a pharmaceutical developer from Stockholm Sweden, announced the recent FDA approval of their drug, Kineret, for the treatment of NOMID in children.

• bioLytical Laboratories Received CLIA Waiver for their INSTI HIV-1 Antibody Test

  August 20, 2012

  On July 20, 2012, bioLytical Laboratories received a CLIA waiver from the FDA for their INSTI HIV-1 Antibody Test, opening the door for a wider range of laboratory facilities to administer the test.

• Amarex and Montgomery College Team Up for a Successful Clinical Trial Management Course

  August 20, 2012

  In a successful collaboration between private industry and public education, Montgomery College and the experts at Amarex Clinical Research recently concluded the first semester of Clinical Trial Project Management.

• Amarex Passes FDA Audit with High Compliments from FDA Auditor

  February 4, 2010

  Amarex Clinical Research was informed by the FDA that Amarex had been randomly selected for a GCP audit of her CRO services business, giving Amarex less than a week to prepare.