Citing clinical trial data backed by real-world data, members of the U.S. FDA’s Antimicrobial Drugs Advisory Committee voted overwhelmingly, 16-1, March 16 that the overall benefit-risk assessment is favorable for the use of Pfizer Inc.’s Paxlovid to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Biontech, Bioprojet, Cognition, Deciphera, Edesa, Pfizer, Skye.
Nucleoside or nucleotide antivirals are a common first-line treatment for viral diseases, acting as direct inhibitors of viral replication and transcription. The nucleoside GS-441524 and its prodrug remdesivir have shown broad-spectrum antiviral activity against several virus families, including Flaviviridae, Filoviridae, Pneumoviridae, paramyxoviruses and Coronaviridae.
Pfizer Inc.’s Paxlovid has become such a part of the COVID-19 treatment scene in the U.S. that it’s easy to forget it’s only authorized for emergency use. That could soon change. The FDA is convening its Antimicrobial Drugs Advisory Committee March 16 to consider Pfizer’s NDA for the co-packaged nirmatrelvir and ritonavir treatment.
Exevir Bio BV has announced research detailing a novel, highly potent, anti-S2 camelid single-domain antibody, discovered at the VIB-Ugent Center for Medical Biotechnology, and developed as a candidate drug molecule by Exevir as XVR-013.
Researchers from Case Western Reserve University presented data from a study that aimed to investigate gut integrity, oxidized lipids and inflammatory markers associated with the pathogenesis of post-acute sequelae of COVID-19 (PASC).
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.