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U.S. FDA warning letters for medical devices are relatively rare these days, and the Oct. 6, 2022, warning to Empowered Diagnostics LLC of Pompano Beach, Fla., suggests that COVID tests are still front and center where FDA enforcement is concerned.
Clinical trials in China are growing up in much the same way the R&D enterprise in China has grown up. They are evolving and becoming more sophisticated, reflecting the maturation of the R&D environment around them.
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.
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.
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