Media / News Releases
Nov 18, 2020
The regulatory department at Amarex Taiwan, LLC, an NSF International company, recently submitted a new drug application (NDA) on behalf of its client. The Amarex team also wrote a substantial portion of the NDA and did the publishing.
Oct 21, 2020
Amarex Taiwan, LLC, an NSF International company announced that the U.S. FDA granted Fast Track designation to Amarex’s client PRG S&T Inc. for PRG’s drug Progerinin, being tested as a treatment for Hutchinson-Gilford Progeria Syndrome (HGPS) and Werner Syndrome (WS).
Oct 07, 2020
Amarex client, Amytrx Therapeutics (“Amytrx”), recently initiated clinical testing of their anti-inflammatory therapeutic product AMTX-100 for dermatological diseases and conditions with the enrollment of patients in a first-in-man Phase 1/2b study for treatment of mild to moderate atopic dermatitis.
Sep 21, 2020
Amarex Taiwan, LLC (Amarex) client AIM ImmunoTech Inc. (NYSE American: AIM) 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.
Sep 21, 2020
Amarex Taiwan, LLC, an NSF International company announces its client, Frantz Viral Therapeutics, LLC, is now enrolling for their Phase IIb pivotal clinical trial of Artesunate Vaginal Inserts for the treatment of biopsy-proven HPV-associated cervical intraepithelial neoplasia 2/3 (CIN2/3) in adult female patients.
Sep 09, 2020
Amarex Taiwan, LLC, an NSF International company announces today that earlier this week they received a study may proceed (SMP) letter from the Taiwan Food & Drug Administration (TFDA) to conduct the first in human clinical trial of RP-72 in Taiwan. RP-72 is a 72 amino acid propriety recombinant protein antagonist for the CXCR1 and CXCR2 receptors of interleukin-8, a drug that treats pancreatic cancer. In early 2020, Amarex also received a SMP letter from the U.S. FDA for RP-72 to treat pancreatic cancer.
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.