Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval. Read More
PERTH, Australia – New Zealand’s single payer, Pharmac, funded 13 new medicines and widened access to 19 medicines in 2021 that are expected to benefit about 45,426 New Zealanders, according to the agency’s year in review report. Read More
China’s NMPA has given conditional approval to Pfizer Inc.’s COVID-19 oral pill Paxlovid (nirmatrelvir/ritonavir). The drug was approved for the treatment of adults with mild to moderate COVID-19 and a high risk of progression to severe disease. This includes the elderly, and people with chronic kidney issues, diabetes, cardiovascular, and chronic lung disease. Read More
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China. Read More
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. Read More
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. Read More
Biopharmas in Asia-Pacific raising money in public or private financings: Bugworks Research, Ethris, Linkinvax, Merck, Statera, TC, Teclison, Ucello. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Akso, Arbor, Astrazeneca, Atea, Aveta Biomics, Biontech, Brickell, Bridge, Carna, Cold Spring Harbor Laboratory, CSIR-Central Drug Research Institute, Edigene, Glenmark, GSK, Huadong Medicine, Hummingbird, IGM, Immunome, JN Nova, Laboratorio Libra, Liscure, Luye, Merck, Orange Grove, Pfizer, Qilu Regor, Regor, Ridgeback, Scripps Research Institute, Takeda, Tevogen, Vir. Read More
