Delivering important but likely unwelcome news to Americans increasingly trying put the COVID-19 pandemic behind them, new research published Feb. 11 by the CDC suggested that "protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection against COVID-19-associated [emergency department or urgent care (ED/UC)] encounters and COVID-19 hospitalizations."

Redhill Biopharma Inc. continues pushing ahead with efforts to add to the limited arsenal of therapies for treating hospitalized severe COVID-19 infections, with the latest data, based on prespecified analyses from a phase II/III study showing its SK2 inhibitor, opaganib, significantly reduced mortality when given on top of standard-of-care (SOC) Veklury (remdesivir, Gilead Sciences Inc.) and corticosteroids. The Tel Aviv, Israel-based company said potential emergency use and marketing applications are planned in the first half of this year.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biontech, Cassava, Edigene, Johnson, Legend, Metacrine, Moderna, Pfizer.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Center for Pain & Stress Research, Esaote North America.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cstone, Dermata, Elpiscience, Eureka, Gamida, Glenmark, Polypid, Qurient, Sanotize, Synthetic Biologics.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Affimed, Akso, Cell and Gene Therapy Catapult, Generium, Glaxosmithkline, Healis, Huadong Medicine, Mediwound, Merck, Mica, Nanobiotix, Quris, Second, Selexis, Vir, Virpax.

Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.

More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.