Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Therapeutics, Arch, Bridgebio, Inovio, Intensity, Invivyd, Melt, Obi.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, CSL, Galecto, Immunicum, Mineralys.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adimab, AFT, Alpine Immune, Astellas, Genovior, Hyloris, Immunoscape, Juniper, Linkedup, Mithra, Polaris, Propella, Rafa, Shionogi, Tianti.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Almirall, Annexon, Annexon, Apnimed, Arcturus, Biolinerx, Clene, CSL, Demata, Immunovant, Inventiva, IO, Mithra, Passage, Sanofi, Tonix, Vaxart.

With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the development of monoclonal antibodies to treat or prevent COVID-19 to the use of real-world data in drug development.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, Cellvax, Chiesi, Iama, Impact, Ocelot, Pfizer, Uvax.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anheart, Arcutis, Avstera, Catalyst, Checkpoint, Cyclo, GC Pharma, Innovent, Irlab, Lexeo, Merck & Co., Novavax, Nrx, Pfizer, Santhera, Sirnaomics.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Aulos, Azura, BMS, Cara, CNS, Cyclacel, Daiichi, Ethris, GSK, Highfield, Innocare, Invivyd, Lantheus, Mirum, Mithra, Nectin, Neuren, Nicox, Oculis, Pepgen, Sensorion, Structure, Ultimovacs, Viridian, Windtree, Yoltech.

Invivyd Inc.’s VYD-222 produced positive initial top-line results in the ongoing pivotal phase III Canopy study for preventing symptomatic COVID-19. The results could reach a vulnerable population of patients who are immunocompromised and don’t get the same protection as other patients, the company’s CEO, Dave Hering, told BioWorld.