Aridis Pharmaceuticals Inc. is one of two companies posting COVID-19 data just days before Christmas. Its fully human monoclonal antibody cocktail, AR-701, was shown to be broadly reactive against COVID-19 variants, including Omicron, in preclinical research. Moderna Inc. also posted new data that showed preliminary neutralizing data against Omicron following 50-mg doses of its vaccine, which is currently authorized, and 100-mg dose boosters, which increased neutralizing antibody levels 83-fold from the pre-boost levels.

Everest Medicines Ltd. and Providence Therapeutics Holdings Inc.’s COVID-19 vaccine was cleared for inclusion in the World Health Organization’s (WHO) Solidarity Trial Vaccines clinical trial.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Alnylam, Argenx, Astrazeneca, Bluebird, Cara, Coherus, Edenbridge, Editas, Everest, GBT, Intra-Cellular, Lannett, Lysogene, Moderna, Novavax, Polarityte, Poseida, Providence, Sorrento, Takeda, Telix, Zogenix.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affera, Cytosorbents, Magforce, Vesper, Xeltis, Zynex.

Everest Medicines Ltd. and Providence Therapeutics Holdings Inc.’s COVID-19 vaccine was cleared for inclusion in the World Health Organization’s (WHO) Solidarity Trial Vaccines clinical trial.  

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Basilea, Biogen, Eisai, Erasca, Glaxosmithkline, Global Blood, Karyopharm, Lyell, Medicago, Medicenna, Merck & Co., Miromatrix, Obseva, Paratek, Pfizer, Seagen, Senhwa, Vir, Xalud, Zai.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Regent, Aptose, Biogen, Biontech, Chord, Clarametyx, Claritas, Contrafect, Cytokinetics, Dyadic, Eisai, Emotional, Fibrogen, Freya, Gilead, Helsinn, Hifibio, Jaguar, Ji Xing, Johnson & Johnson, Merck, Moderna, Mylan, Noorik, Novo, Oragenics, Paratek, Pfizer, Sandoz, Sirona, VBL, Vifor, Xediton, Zai.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzamend, Bellerophon, Glycomine, Merck, Mindmed, Navidea, Passage, Ridgeback, Taysha, UCB, Vincerx.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, BMS, Braeburn, Calliditas, Camurus, Daiichi, Innoskel, Mesoblast, Mitotech, Neuvivo, Nkarta, Novavax, Pfizer, Rakuten, Sobi, Verrica, Zai Lab.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advaxis, Amplyx, Biomarin, Cadila, Cassiopea, Cava, Cosmo, Hyloris, Iktos, Kineta, Lipidor, Mynd, Pfizer, Providence, Purdue, Skyline, Vaneltix, Vera.