New Diagnostics Have Potential to Increase Capacity of COVID-19 Testing in U.S. by Thousands of Tests Per DayContinue reading
Author Archive: AZBio
FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp
On March 16, 2020, the U.S. Food and Drug Administration took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.Continue reading
Flinn Foundation issues grant to support COVID-19 testing, cancels events
Responding to the COVID-19 pandemic, the Phoenix-based Flinn Foundation has issued an emergency $100,000 grant to the Translational Genomics Research Institute (TGen) to support population-based testing of the novel coronavirus in Arizona and to help TGen immediately and dramatically ramp up its capacity to analyze individual samples for the disease. Continue reading
Pfizer Outlines Five Point Plan to Battle COVID-19
Pfizer Chairman and CEO Albert Bourla Calls on Biopharma Industry to Collaborate on Combatting the Global PandemicContinue reading
Insights and Priorities Related to COVID-19 shared by an Arizona Emergency Physician and Legislator
Amish Shah, MD is an emergency physician at Dignity Health and a member of the Arizona House of Representative elected by the people of LD24 – Central Phoenix and South Scottsdale. On Friday at 5:17 PM, Dr. Shah shared the message below via Facebook. With his permission, we are sharing it with you.
Solving obesity: Could manipulating microbes offer an alternative to weight loss surgery?
Already considered a global epidemic, human obesity continues to be on the rise. According to the Centers for Disease Control, more than 40% of the U.S. population is considered obese. The gamut of adverse health effects associated with obesity is broad, including such devastating illnesses as type 2 diabetes, coronary artery disease, stroke, sleep apnea and certain forms of cancer. Patients often suffer depression, loss of mobility, social isolation and inability to work.
With costs approaching $316 billion dollars annually in the U.S., understanding how to quell obesity will result not only in a healthier population, but could also help reduce runaway medical costs.Continue reading
FDA Issues EUA for Emergency Use of the Thermo Fisher TaqPath COVID-19 Combo Kit
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)
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