Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Allovir, Arcutis, Astrazeneca, Biontech, Celltrion, Coherus, Cour, Daiichi, Heron, Himalaya, Janssen, Kite, Moderna, Novartis, Pfizer, Relmada, Turning Point, Zosano.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Aipharma, Alloy, Alzecure, April19, Dr. Falk, Enveric, Evenus, Lanier, Mindmed, Mydecine, Nabriva, Pacira, Regenerx, Renexxion, Secarna, Taysha, Vedanta, Vistagen.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx, Annovis, Bayer, Biogen, Brii, CTI, Emphycorp, Enanta, Erytech, Galapagos, Horizon, Immunitybio, Incyte, Kintor, Janssen, Kaleido, Lutris, Lyra, Mannkind, Mereo, Merck, Opthea, PDS, PEP-Therapy, Pharmaxis, Redhill, Regenxbio, Roche, SAB, Sage, Sarepta, Som, Surface Oncology, Telix, Ultragenyx, Unity, Vedanta, Vyne, X4, Xenon, Zymeworks.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Labcorp.

In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.”

DUBLIN – Redhill Biopharma Inc. is claiming a 62% relative reduction in day 42 mortality from COVID-19 among hospitalized severe patients who received its oral drug, opaganib, as compared with those on placebo. It is also reporting a shorter median time to discharge (10 days vs. 14 days) and a higher proportion of patients on treatment being able to breathe unassisted by day 14 (77% vs. 63.5%).

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Humanigen, Kite, Omeros, Xbrane.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anpac, Astrazeneca, Atara, Autotelic, Beximco, Casma, Cassiopea, Clearside, Compugen, Cosmo, Dynavax, Dyne, Eyegene, Forge, Inhibikase, Inozyme, Keros, LB Pharmaceuticals, Minovia, Oncotelic, Oragenics, Pierre Fabre, Sandoz, Solid, Stridebio, Therapeutic Solutions, Tonix, Trilink.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Active Biotech, Adverum, Altimmune, Alzecure, Ambrx, Amgen, Amolyt, Anaptysbio, Apellis, Appello, Biophytis, Biontech, Boehringer, Bridgebio, Cara, Clearside, Contrafect, Covis, Cstone, Enanta, Enlivex, Enteris, Kyowa Kirin, Lilly, Merck, Ose, Precigen, Revelation, Ridgeback, Ultimovacs.