Entire HTG RUO profiling assay menu now available for use on both Illumina’s and Thermo Fisher Scientific’s NGS platformContinue reading
Category Archives: AZBio News
UArizona Aims to Provide Rapid Tests for First Responders, Those on Battlefields Exposed to Biothreats, Such as COVID-19
Thanks to a U.S. Department of Defense contract for as much as $9.5 million, the University of Arizona College of Medicine – Phoenix and partners aim to develop a portable device to easily and accurately detect biological threats, including the virus that causes COVID-19.Continue reading
President Trump Unveils Four Industry Related Executive Orders on Friday July 24th
- Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen
- The Fourth Executive Order, relating to “Most Favored Nations” pricing for Medicare Part B treatments is set to take effect on August 24, 2020 unless industry and the administration agree to an alternate plan.
Innovators Get a Green Light from DOJ to Share Information That Could Expedite Future COVID-19 Treatments
Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GlaxoSmithKline recieved approval from DOJ on July 23, 2020 to share information about manufacturing facilities and other information that could enable them to expedite the production of monoclonal antibody treatments that are determined to be safe and effective to treat COVID-19.
Aesthetics Biomedical® Raises Multi-Million-Dollar Funding Round to Expand Vivace® and SoME® Skincare Products
Phoenix-based biomedical innovator holds numerous patents and trademarks in the rapidly growing aesthetics industry
“Decathlon’s investment allows us to deliver these ground-breaking aesthetic treatments and products to providers and consumers and continue to build the most innovative solutions in the marketplace.”Continue reading
The Rockefeller Foundation Launches New Testing Strategy to Keep U.S. Economy Open
Calls for at least $75 billion in additional funding and the CDC to lead with testing protocols
Commits $100 Million in Rockefeller Foundation Funding for Global Coronavirus ResponseContinue reading
C-Path’s PSTC, D-RSC Receive Positive FDA Response for Drug-Induced Skeletal Muscle Injury Biomarkers
Safety biomarkers aim to provide an additional tool for detecting acute drug-induced skeletal muscle injury in phase 1 clinical trials.
TUCSON, Ariz., July 22, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) issued a positive response to the Letter of Intent (LOI) developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC), for a panel of four safety biomarkers of acute drug-induced skeletal muscle injury.
C-Path’s PSTC, D-RSC Receive Positive FDA Response to Plan for Liver Safety Biomarker
Biomarker aims to provide an additional tool for detecting the onset of hepatic injury in clinical trials involving patients with inherited muscle disorders.
TUCSON, Ariz., July 21, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) from the U.S. Food and Drug Administration (FDA) issued a positive response to the Qualification Plan (QP) for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury (DILI), developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC).
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Ashion Analytics announces innovative cancer treatment partnership with Elevation Oncology
Ashison Analytics GEMExTra test detects rare NRG1 gene fusions in patients whose cancer is driven by this genomic alteration for potential matching to a clinical trialContinue reading