Ascletis Bioscience Co. Ltd. has patented nucleoside and nucleotide analogues reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Shares of Chinese and South Korean med-tech companies continued to rise after the World Health Organization declared mpox a public health emergency of international concern Aug. 14 after recent outbreaks.
About two months after Astrazeneca plc said its application for sipavibart (AZD-3152) had been accepted by the EMA for pre-exposure prophylaxis (PrEP) against COVID-19 in immunocompromised people, Invivyd Inc. unveiled positive 180-day exploratory efficacy data from the company’s ongoing Canopy phase III trial with Pemgarda (pemivibart) in the same indication – and made known less happy news from regulators on the other side of the pond.
Rockefeller University has disclosed non-structural protein 3 (nsp3; PL-PRO) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Researchers have identified a gene associated with whether patients hospitalized with respiratory viral infections recover rapidly or face life-threatening complications. The gene has the potential to be used as a diagnostic tool or biomarker, which could help triage patients suffering from severe respiratory infections. Having such a biomarker would help clinicians in their early risk assessments to manage their intervention strategies.
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.
The U.S. National Institutes of Health sponsored a study that was designed to establish whether there are any biomarkers that are strongly associated with the constellation of symptoms known as long COVID, but the study shed little light on the question.
The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.
The U.S. FDA’s draft guidance for in vitro diagnostics under a Section 564 public health declaration broke little new conceptual ground, but the Association for Molecular Pathology (AMP) urged the agency to reconsider the COVID-19 experience.
