Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerami, Allgenesis, Alimera, Alzecure, Clarity, Curium, Cybin, Daiichi, Eloxx, Galapagos, Geovax, Immunos, Immutep, Innovative Cellular, Lassen, Lisata, Mereo, Peptilogics, Pliant, PTC, Quoin, Thermosome, Trialspark.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Alnylam, Alpine, Anixa, Apnimed, Atyr, Bridgebio, Candel, Corium, Hanall, Hepion, Immix, Medincell, Milestone, Mink, Mirum, Neurimmune, Novartis, Novo Nordisk, Rain, Redhill, Regeneron, Salubris, Vicore.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Antengene, Galera, Immupharma, Pepgen, Vifor, Westvac.

China's National Medical Products Administration (NMPA) has given drug clinical trial approval for two new COVID-19 vaccines against the current XBB variants developed by Westvac Biopharma Co. Ltd. and West China Medical Center at Sichuan University.

Dihydroorotate dehydrogenase (DHODH) is an enzyme ubiquitously expressed in all tissues whose inhibition has proven effective in preventing viral replication. Previous knowledge on DHODH inhibitor vidofludimus calcium demonstrated that this compound inhibits viral replication of DNA, RNA and retroviruses and induces innate immune responses that lead to an antiviral state thus inhibiting virus reactivation.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aravive, Astellas, Bayer, Bioartic, Bionxt, Biophytis, Cabaletta, Cormedix, Eisai, Kamada, Kimera, Orchard, Phio, Sarepta, Virios, YS.

Kimera Labs Inc. has received IND approval from the FDA to study the company’s exosomes in a phase I/IIa trial, which is set to begin next month.