New Drug Application to the U.S. FDA for Parkinson’s Treatment

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​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. 

U.S. FDA Grants Fast Track Designation to Amarex Client PRG S&T Inc.

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​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).

Amytrx Enrolling Clinical Trial of AMTX-100 in Patients with Atopic Dermatitis

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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.

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

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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.

Now Enrolling for a Phase IIb Trial Treating Patients with HPV-Induced CIN2/3

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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.

Amarex Receives SMP Letter from TFDA for an Oncology Drug Clinical Trial Treating Pancreatic Cancer

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​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.

Amarex in the Fight Against COVID-19

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In early March, Amarex Taiwan, LLC, an NSF International company began work on a potential treatment for Coronavirus Disease 2019. Since then, Amarex has helped 16 companies on 32 separate projects for COVID-19 products.