While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Novacyt, Radiaction, Transit Scientific.
Molecular Sensoring Technology Co. Ltd. (Molsentech) has developed a diagnostic platform using semiconductor chips with biosensors for COVID-19 testing. The platform could deliver a result anywhere from three to 30 minutes, with accuracy compatible to the polymerase chain reaction (PCR) tests.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptitude Medical, Depuy Synthes, Sol-Millennium.
The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Heartflow, Proteomedix, SQI Diagnostics.
The U.S. FDA’s device center recently advised companies that make tests for the COVID-19 pandemic that the emergency use authorization program for tests is winding down, albeit with a few exceptions.
Three months after agreeing to an intellectual property waiver for COVID-19 vaccines, World Trade Organization (WTO) members are discussing expanding it to therapies, diagnostics and devices used in preventing, diagnosing and treating COVID-19 infections.
The 2022 Albert Lasker Basic Medical Research Award has been awarded to Richard Hynes, of the Massachusetts Institute of Technology, Erkki Ruoslahti, of the Sanford Burnham Prebys Medical Discovery Institute, and Timothy Springer, of Harvard Medical School “for discoveries concerning the integrins, key mediators of cell-matrix and cell-cell adhesion in physiology and disease.”
The COVID-19 pandemic may or may not be over, depending on which member of the U.S. government’s executive branch one asks, but the FDA’s device center has drawn much tighter lines around its emergency use authorization (EUA) program for COVID-19 tests.
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