Category Archives: AZBio News

First-Ever Treatment Shown to Reverse Alzheimer’s Earns NeuroEM Therapeutics FDA Breakthrough Device Status

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PHOENIX–(BUSINESS WIRE)–NeuroEM Therapeutics is poised to deliver a knockout blow to Alzheimer’s disease. The clinical-stage medical device company is pleased to announce FDA Breakthrough Device designation for its bioengineered head device shown to reverse Alzheimer’s memory loss in its pilot study, published last fall in the Journal of Alzheimer’s Disease.

“No other drug or device has received this highest FDA designation to accelerate a treatment for Alzheimer’s disease,” said Dr. Robert Matthews, PhD, CEO of NeuroEM Therapeutics. “No other treatment has demonstrated the clinical results we have thus far, to not only slow but in fact reverse the progressive, debilitating loss of memory caused by this devastating brain disease.”Continue reading→

OncoMyx Therapeutics Appoints Dr. Charles Baum Chairperson of Board of Directors

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PHOENIX, November 6, 2020 – OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, today announced the appointment of Charles (Chuck) M. Baum, M.D., Ph.D., as chairperson of the company’s board of directors. Dr. Baum is currently president and chief executive officer of Mirati Therapeutics, which develops novel therapeutics that target the genetic and immunologic drivers of cancer. He has more than 25 years of experience leading the clinical development of precision oncology drugs, including axitinib (Inlyta®), crizotinib (Xalkori®), sunitinib (Sutent®), and temozolomide (Temodar®).Continue reading→

Pediatric IBD Foundation, ImproveCareNow, C-Path to Establish the Children’s Registry for the Advancement of Therapeutics

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TUCSON, Ariz., November 5, 2020 — The Pediatric IBD Foundation, ImproveCareNow, and the Critical Path Institute (C-Path) are proud to announce a collaboration establishing the Children’s Registry for the Advancement of Therapeutics (CREATE™). CREATE™ is a drug-agnostic safety registry designed to support the completion of global post-marketing safety requirements, as well as collect safety information on all therapies used in pediatric IBD patients.

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HTG Demonstrates Technical Feasibility for a Whole Transcriptome Panel Using HTG EdgeSeq Technology

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TUCSON, Ariz., Nov. 02, 2020 (GLOBE NEWSWIRE) — HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced the completion of proof of concept for a whole transcriptome panel using the HTG EdgeSeq technology, and release of a White Paper illustrating the feasibility and performance of this prototype panel relative to RNA sequencing (RNA-Seq). As previously discussed, HTG is developing a whole transcriptome panel utilizing the HTG EdgeSeq technology to measure approximately 20,000 mRNA targets, with a planned RUO launch in mid-2021.Continue reading→

FDA Awards C-Path Grant to Use Real-World Data to Generate Real-World Evidence in Neonates

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Pilot project will include the development of a Real-World Data and Analytics Platform

TUCSON, Ariz., October 27, 2020 — Arizona-based Critical Path Institute (C-Path) is pleased to announce it has been awarded a multi-year grant by the U.S. Food and Drug Administration (FDA) to advance standards and methodologies designed to generate real-world evidence (RWE) from real-world data (RWD) through a neonatal pilot project through the International Neonatal Consortium (INC).Continue reading→