Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Advicenne, Astrazeneca, Bluejay, Daiichi Sankyo, Esperion, Invivyd, Regeneron, Tonix.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apogee, Astria, Axsome, Beyondspring, Cassava, Invivyd, Matinas, Syros.

The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Cocrystal, Cosmo, CSL Vifor, Deverra, Forge, Hasten, Lib, Orchard, PTC, Revive.

Merck & Co. has revealed the discovery of novel oral SARS-CoV-2 3C-like proteinase (3CLpro; Mpro) inhibitors for the potential treatment and/or prophylaxis of COVID-19. 3CLpro plays a key role in viral life cycle by cleaving viral protein and helps in replication and infection, which make 3CLpro a target for designing drugs to treat COVID-19.

Hyundai Bioscience Corp. is set to become the largest shareholder of ADM Korea Inc., a Seoul, South Korea-based contract research organization (CRO) firm, by purchasing 5.02 million shares for ₩20.4 billion (US$15.5 million) – a 23% stake.

Additional early-stage research and drug discovery news in brief, from: Calder Biosciences, Inhalon Biopharma.

Hyundai Bioscience Corp. is set to become the largest shareholder of ADM Korea Inc., a Seoul, South Korea-based contract research organization (CRO) firm, by purchasing 5.02 million shares for ₩20.4 billion (US$15.5 million) – a 23% stake.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzprotect, Astrocyte, Bavarian Nordic, Clearmind, Cybin, Imunon, Innocare, Pacira, Pepgen, Pfizer, Prilenia, Psyence, Puretech.

Imunon Inc. has filed an IND application with the FDA seeking clearance to begin a phase I study of IMNN-101 as a seasonal COVID-19 booster vaccine.