On February 12, 2020, Plasmology4®, Inc., a leader in Plasma Medicine, announced that the company’s product has been granted into the U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program for the treatment of “multidrug-refractory bacterial and/or fungal pathogen bioburden in a wound bed.”Continue reading
Category Archives: AZBio News
Medtronic Continuing to Increase Ventilator Production to Address COVID-19 Pandemic
DUBLIN, March 18, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, continues to make progress in increasing ventilator production worldwide. The company has increased production by more than 40 percent to date and is on track to more than double its capacity to manufacture and supply ventilators in response to the urgent needs of patients and healthcare systems across the globe confronting COVID-19.
C-Path and Lundbeck Announce a Data Sharing Collaboration to Enable Development of Advanced Drug Development Tools in Alzheimer’s Disease
TUCSON, Ariz., March 18, 2020 — The Critical Path Institute (C-Path) and H. Lundbeck A/S (Lundbeck) are proud to announce that they will work together to significantly improve the scientific community’s insight in Alzheimer’s disease (AD) through Lundbeck’s contribution of a unique set of clinical trial data from more than 2,500 AD patients to the Critical Path for Alzheimer’s Disease (CPAD) consortium’s integrated database for qualified researchers across the globe to access.Continue reading
BD, BioGX Announce FDA Emergency Use Authorization Submissions for New COVID-19 Diagnostics for Use in U.S.
New Diagnostics Have Potential to Increase Capacity of COVID-19 Testing in U.S. by Thousands of Tests Per DayContinue reading
C-Path to Lead Multi-Stakeholder Engagement on FDA’s Proposed Novel Framework to Enhance the Pediatric Medical Device Ecosystem
TUCSON, Ariz., March 17, 2020 — The Critical Path Institute (C-Path) today announced it has been awarded a grant to conduct stakeholder engagement to garner insights, feedback and refinement of the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health’s (CDRH) proposed framework to enhance the pediatric medical device ecosystem and to develop a strategic plan for implementation. Funded by a cooperative agreement through the FDA, C-Path will work in collaboration with CDRH and other stakeholders to organize a workshop to brainstorm on the framework and strategic plan for building a viable ecosystem.Continue reading
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
C-Path Appoints Dr. Klaus Romero as Chief Science Officer
TUCSON, Ariz., March 16, 2020 — The Critical Path Institute (C-Path) today announced the appointment of Klaus Romero, M.D., M.S., F.C.P., as its new Chief Science Officer (CSO) effective April 1, 2020. Dr. Romero, a clinical pharmacologist and epidemiologist with more than 17 years combined experience in academic and pharmaceutical clinical research, translational sciences, pharmacometrics, modeling and simulation and pharmacoepidemiology, has been with C-Path since December 2007. His most recent role has been as Executive Director of Clinical Pharmacology and Quantitative Medicine. He will continue in dual roles as CSO and head of the Quantitative Medicine Program.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.