Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adicet, Aldeyra, Aveo, Bavarian Nordic, Biorestorative, Bioxytran, Black Diamond, Cassava, Edgewise, Eli Lilly, Freya, Harpoon, Idorsia, Inozyme, Lobe, Meiragtx, Minervax, Nkarta, Regulus, Sanofi.
Eubiologics Co. Ltd. said it would file for regulatory approval for its COVID-19 vaccine called Eucorvac-19 in the Philippines, after announcing positive interim phase III trial results on June 27.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Invivyd, Pharvaris.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amylyx, Astrazeneca, Boehringer Ingelheim, Erasca, Gilead, Intercept, Janssen, Leo, Lianbio, Moderna, Molecure, Pfizer, Sarepta, Zealand.
The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend COVID-19 vaccines for the 2023-2024 vaccination campaign be monovalent vaccines that target the XBB variants, currently the most prominent variants of the SARS-CoV-2 virus.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bloomsbury, Lantern, Merck & Co., Neobiosis, Pharmala, Phathom.
The intellectual property waivers for American vaccines for the COVID-19 pandemic are still controversial, but the World Health Organization (WHO) is nonetheless seeking a similar set of waivers for therapies and tests for COVID. A subcommittee of the House Judiciary Committee met June 6 to review these waivers, and subcommittee chairman Darrell Issa (R-Calif.) said he intends to continue pushing legislation that would require the U.S. president to obtain congressional approval for agreeing to any such waivers in the future.