The latest global regulatory news, changes and updates affecting biopharma, including: Canada moves to make some COVID-19 flexibilities permanent; Industry group forms to advance subcutaneous technology.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Biontech, Catalyst, Elusys, Kempharm, LG Chem, Mesoblast, Oyster Point, Pfizer, Protagonist, Regent, Telix, Vanda, Wanbang.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abveris, Adamas, Aicuris, Aptevo, Atbtherapeutics, Biocardia, Bio-Techne, Boehringer Ingelheim, Endo, Exelixis, Global Blood, Grünenthal, Hemera, Hepion, Ibio, Iconic, Ionis, Janssen, Kancera, Metuchen, Nabriva, Neurotrope, Osmotica, Petros, Pharmacyte, Puma, Qualigen, Regent Pacific, Regulus, Saccharo, Shanghai Fosun, Sterotherapeutics, Tetra Bio-Pharma, Therapix, Tubulis, Wuxi Apptec, Wuxi Biologics, Zymeworks.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adrenomed, American Cryostem, Ampio, Appili, Arcutis, Astrazeneca, Axsome, Bacainn, Calithera, Cara, Cytodyn, Galapagos, Insmed, Ionis, Mycovia, Oramed, Silo, Sio, Targovax, TG.

The latest global regulatory news, changes and updates affecting biopharma, including: HIV trial networks streamlined; Grants to advance use of RWD, RWE; GAO, National Academies, report on AI in health care; ICER not sold on roxadustat; Teva, Cephalon latest EC targets; Hungary looks to Russian vaccine.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Amicus, Autobahn, Biontech, Bridgebio, Cerecor, Gilead, Incannex, Ipsen, Janssen-Cilag, Junshi, Merz, Minerva, Moderna, Moleculin, Pfizer, QED, Rhizen, Roche, Tearclear, TG, VBI.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abfero, Actavis, Adamis, Amarin, Anixa, Astrazeneca, Auris, Beigene, Bioclonetics, Biohaven, Casma, Cel-Sci, Chrysalis, Dragonfly, Elevar, Entheon, Enzolytics, ERS, Eversana, Grünenthal, Helsinn, Hikma, Horizon, Janssen, Kyowa Kirin, Luca, Macrogenics, Merck & Co., Newstem, Novelstem, Outlook Sanyou, Sesen, Sosei, Specifica, Sun, Tris, UCB, Vigeneron, Vipergen, Vivlion, Wuxi Apptec, Zymeworks.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Agios, Allysta, Astrazeneca, Athira, Axsome, Beigene, Bellerophon, Celularity, Codagenix, Dr. Reddy's, Galapagos, Genprex, Histogen, Ionis, Junshi, Neurotherapia, Nordic, Phathom, Plus, Rafael, Regenxbio, Russian Direct Investment Fund, Therapeutics Solution, Travere, Vyne, Zymeworks.