Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, American Cryostem, Cleave, Genentech, Innovent, Inventiva, Jnana, Ligan, Novan, Pfizer, Precision, Rani, Transgene, UCB.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arthrosi, Atai, Celularity, Curevac, Effector, Genoscience, Graphite, Madrigal, Medicinova, Medincell, Nexcella, Visen.
Shaanxi Panlong Pharmaceutical Group Co. Ltd. has disclosed proteolysis targeting chimeras (PROTACs) comprising cereblon (CRBN) ligands coupled to 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) targeting moiety via linker acting as 3CLpro (SARS-CoV-2) degradation inducers reported to be useful for the treatment of SARS-CoV-2 infection.
Raynovent Biotech Co. Ltd. has raised ¥370 million (US$54 million) in a series C round to further develop candidates in the field of respiratory and metabolic diseases. Funds will be used to accelerate clinical trials of lead candidates in its pipeline, as well as to prepare for the commercialization of oral pills to treat COVID-19 and influenza A virus.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Astrazeneca, Azafaros, Fabre-Kramer, Innovent, Jubilant, Lantern, Orchard, Revive, Sosei, Vaxcyte.
In the fourth year of the COVID-19 pandemic, the World Health Organization is monitoring two omicron subvariants, BA.5.2 and BF.7, causing a surge of COVID-19 cases in China. It also is keeping abreast of rising XBB.1.5 cases and declining BQ.1 cases in Europe and the U.S., where hospitalizations have increased in recent weeks. Global cases in the last month are trending below the same timepoints in 2020 and 2021, and deaths are significantly down, suggesting a move toward an endemic stage.
China’s NMPA has approved Merck & Co. Inc.’s COVID-19 treatment molnupiravir for emergency use to combat the increasing number of cases in the country.
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.
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