Clinical updates, including trial initiations, enrollment status and data readouts and publications: Applied, Asklepios, Boston, Curevac, Deciphera, Delta-Fly, Kiromic, Merck, Newron, Orion, Rivus, Verrica.

An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Therapeutics, Arch, Bridgebio, Inovio, Intensity, Invivyd, Melt, Obi.

University of Alberta has divulged 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of viral infections.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, CSL, Galecto, Immunicum, Mineralys.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adimab, AFT, Alpine Immune, Astellas, Genovior, Hyloris, Immunoscape, Juniper, Linkedup, Mithra, Polaris, Propella, Rafa, Shionogi, Tianti.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Almirall, Annexon, Annexon, Apnimed, Arcturus, Biolinerx, Clene, CSL, Demata, Immunovant, Inventiva, IO, Mithra, Passage, Sanofi, Tonix, Vaxart.

With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the development of monoclonal antibodies to treat or prevent COVID-19 to the use of real-world data in drug development.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, Cellvax, Chiesi, Iama, Impact, Ocelot, Pfizer, Uvax.