Armed with data but no crystal ball, the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) will be asked June 28 to predict the next-generation vaccines that will be needed to best respond to the COVID-19 futurescape. While Moderna Inc., Pfizer Inc. and Novavax Inc. will briefly present clinical data for their variant vaccines at the VRBPAC meeting, the discussion will be about the future of all COVID-19 vaccines being developed or authorized for the U.S. market.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Amryt, Argenx, Basilea, Biomarin, Croma, Cytokinetics, Daewoong, Emergent, Gilead, Janssen, Kyowa Kirin, Merck, Novartis, Novavax, Oncopeptides, Sarepta.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ainos, Antengene, Artelo, Basilea, Beigene, Defence, Degron, Kuria, Merck, Redx, Scohia.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akston, Biolexis, Calithera, GSK, Intellia, Regeneron, Sanofi.

Sanofi SA and GSK plc said new phase III data show their adjuvanted bivalent D614 and beta (B.1.351) COVID-19 vaccine candidate responded well against omicron despite it being designed to fight the original SARS-CoV-2 virus and the beta variant.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alterity, Amryt, Astrazeneca, Biontech, CNS, Fusion, Menarini, Merck & Co., Novartis, Novavax, Radius, Realta, Rockwell, Valneva.

In a rare move, Australia’s Therapeutic Goods Administration is allowing two prescription-only COVID-19 treatments to be advertised to the public.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3Spine.