The scope of this authorization is limited to the use of the authorized TaqPath COVID-19 Combo Kit by authorized laboratories
for the qualitative detection of SARS-CoV-2 in individuals suspected of COVID-19 by their healthcare provider. (FDA Letter)
Category Archives: AZBio News
SEC Regulatory Changes Provide Small Biotech Companies Relief from Burdensome Requirements
The Securities and Exchange Commission (SEC) has adopted regulatory changes to provide small public companies with a temporary exemption from Sarbanes-Oxley 404(b) compliance. 404(b) requires public companies to report on the internal controls they have in place over their financial reporting. While well-intended, this regulatory requirement has proven to reduce market capitalizations, increase audit fees, force companies to exit public markets, and reduce R&D investments in pre-revenue startups that result in fewer inventions.Continue reading
Johnson & Johnson Announces Collaboration with the Beth Israel Deaconess Medical Center to Accelerate COVID-19 Vaccine Development
Research well underway as Janssen scientists collaborate with leading virology laboratory led by Dan Barouch, M.D., Ph.D.Continue reading
Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization and is available in markets accepting the CE mark
First commercial test for SARS-CoV-2 will enable expedited coronavirus testing to meet urgent medical needs
Testing on widely available, high-volume cobas 6800/8800 will significantly increase available testing capacity
Roche expedites test development to support urgent need for patient testing during pandemic outbreak to avoid a further spread of the virus at an early stage of infectionContinue reading
C-Path Selects Experienced Neuroscientist to Lead Alzheimer’s Consortium
TUCSON, Ariz., March 13, 2020 — The Critical Path Institute (C-Path) today announced it has named Sudhir Sivakumaran, Ph.D., as Executive Director of its Critical Path for Alzheimer’s Disease (CPAD) consortium effective immediately. Dr. Sivakumaran, a neuroscientist and research and development professional, has nearly 20 years combined experience in academic, pre-clinical and early clinical research and development, phase 1 and phase 2 clinical study design, data analysis and diligence and business development. He has been with C-Path since July 2019 as Associate Director for CPAD.Continue reading
SynCardia Systems, LLC. 50cc temporary Total Artificial Heart (TAH-t) Now FDA Approved
With the FDA approval of the SynCardia Systems, LLC 50cc TAH-t system a greater number of cardiac transplant eligible patients at risk of imminent death from biventricular failure now have access to total artificial heart therapy.
The 50cc TAH-t is 37.5% smaller than the 70cc device while maintaining a peak cardiac output of 7.5 liters per minute making it ideally suited for smaller statured adults and pediatric patients.Continue reading
AZBio Named One of the 30 Most Innovative Companies in Arizona
Az Business magazine has selected the 30 companies that will be honored at the first Arizona Business Innovation Awards.
The 30 honorees were selected from a pool of hundreds of nominations and include AZBio and AZBio Members Xcellerate Biomedical Technologies.Continue reading
Tech Launch Arizona Kicks Off Entrepreneurial Fellowship Program
Tech Launch Arizona (TLA) recently launched the newly developed Student Entrepreneurial Fellowship Program. The fellows comprise a team of four qualified candidates from a diverse range of backgrounds who are eager to make the most of this rare opportunity. Over the course of their employment with TLA they will work closely with the venture development team and gain valuable experience in the startup assessment and launch process.Continue reading
Phoenix Based Paradigm And Viomics Acquired by Exact Sciences
On March 3, 2020, Exact Sciences Corp. (NASDAQ: EXAS) announced the completion of its acquisitions of Paradigm Diagnostics, Inc. and Viomics, Inc., two privately held companies based in Phoenix. Together, Paradigm and Viomics provide a differentiated late-stage therapy selection test and deep competencies in sequencing and biomarker discovery, extending Exact Sciences’ lab testing and research and development capabilities.Continue reading
New FDA Guidance Issued for Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications
On February 25, 2020, the FDA issued two Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications related final guidance documents.