Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antev, Biogen, Biomarin, Boehringer, Eli Lilly, Inhibikase, Mesoblast, Revive, Sage.
The FDA’s emergency use authorization (EUA) program for rapid antigen tests for the COVID-19 pandemic is coming to an end, but few rapid antigen test makers have laid out clear plans regarding the post-public health emergency world. Quidelortho Corp. managed to beat the competition to the non-EUA market for these tests with a grant of de novo petition for its Sofia rapid antigen test, which now provides other tests with a predicate device, thus ensuring that this will not be the last such test to reach the U.S. market.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ab2, Dyadic, Enthera, Indaptus, Infectious Disease Research Institute, Janssen, Maia, Merck & Co., Panbela, Protagonist, Small.
The U.S. Recover program, set up in July 2022 to identify the causes of long COVID, find biomarkers of disease and discover new therapeutic targets, is now preparing to move to its next phase and begin testing potential treatments in a multi-arm, randomized, placebo-controlled trial. But with 200 different symptoms, and limited understanding of relevant system-level pathological targets, there are significant hurdles to be overcome.
Autoantibodies are typically not good news. But a group of researchers from Bellinzona, Switzerland, have observed that the presence of autoantibodies against chemokines, a special class of cytokines, is associated with mild disease and less risk of developing long COVID. “Our hypothesis was that antibodies to chemokines, if they existed, would also be associated with a negative outcome of the disease. But, what we found, in fact, was the exact opposite of what we were predicting,” Davide Robbiani, director of the Institute for Research in Biomedicine, told BioWorld.
The U.S. Recover program, set up in July 2022 to identify the causes of long COVID, find biomarkers of disease and discover new therapeutic targets, is now preparing to move to its next phase and begin testing potential treatments in a multi-arm, randomized, placebo-controlled trial. But with 200 different symptoms, and limited understanding of relevant system-level pathological targets, there are significant hurdles to be overcome.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptorum, BMS, Merck, Ractigen, Valeo.
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