Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guard Medical, SI-Bone.
“There are hundreds of strains of bird flu, and most of them don’t infect humans, or even mammals,” Stephen Cusack told BioWorld. “There are two main reasons for that.” To be able to cause an infection, a virus “has to be able to get into the cell, and for that it needs a receptor,” Cusack said. For influenza viruses, those receptors are hemagglutinin receptors, and they differ in subtle but important ways between birds and mammals.
The COVID-19 pandemic drove a large volume of in vitro diagnostic test efforts toward the SARS-CoV-2 virus, such as the Biofire respiratory panel by Biofire Diagnostics LLC, of Salt Lake City, a test for which the U.S. FDA released the special controls.
Privacy legislation was passed and implemented in the European Union, but the picture in the U.S. is pockmarked by state legislation, a scenario that raises concerns about a fractured and impracticable compliance regime.
The $180 million Caresyntax GmbH recently raised in a series C extension round allows the company to accelerate the commercialization and adoption of its precision surgery platform, Bjorn von Siemens, CFO and CBO of Caresyntax told BioWorld.
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