After receiving approval in Japan for its orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622) in late November, Shionogi & Co. Ltd. is gearing up for approvals in South Korea and China.

After more than five years and extensive feedback, the U.S. FDA is finalizing its guidance on the format and content of risk evaluation and mitigation strategy (REMS) plans for prescription drugs and biologics associated with serious risks.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bresotec Medical, Imperative Care, Onconano Medicine, Sedana Medical.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Athenex, Evaxion, Gilead, Hotspot, Janssen, Legen, Orasis, Profoundbio.

The U.S. FDA has released the special controls needed for extracorporeal carbon dioxide removal thanks to the successful pursuit of a de novo petition by Pittsburgh-based Alung Technologies Inc., but generating the clinical data for successor 510(k) devices will be no mean feat. While some of the associated in vivo testing may be performed on animal models, the list is extensive and includes testing for hemodynamic instability and inadequate gas exchange, all reasons that Alung and the FDA needed the better part of a decade to bring this device to the U.S. market.

Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Datar Cancer Genetics, Visby Medical.