Author Archive: AZBio

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study

Posted on by
  • Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
  • Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
  • Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
  • Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
  • Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

Continue reading→

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

Posted on by

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

Posted on by

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→

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

Posted on by

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→