Luye Pharma Group Ltd. won marketing approval in China for its risperidone microspheres for injection to treat schizophrenia, which the company said is the first formulation developed by a Chinese company in the space to get a green light. Under the trade name Ruixintuo, the long-acting drug is administered once every two weeks by intramuscular injection. Read More
PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey. Read More
LONDON – A new national consortium of virologists has been set up to systematically assess how mutations in SARS-CoV-2 affect key outcomes such as effectiveness of vaccines and therapies, transmissibility of the virus and the severity of COVID-19 infections. Read More
As the world begins to emerge from a horrific pandemic, it has become abundantly clear that dangerous infections are here to stay, and it is up to health care leaders and citizens to remain prepared and vigilant in preventing another deadly and disruptive COVID-19. Read More
KSQ Therapeutics Inc.’s chief scientific officer, Frank Stegmeier, said that the CRISPRomics technology that drew Takeda Pharmaceutical Co. Ltd. to the table allows, “for the first time, genome-scale functional screening [in vivo as well as in vitro] across multiple disease settings. It really takes the guessing game out of your drug target selection.” Read More
LONDON – Merck & Co. Inc. has become the latest pharma company to in-license a SHP2 small-molecule program, as the rush to find companion pieces for KRAS oncogene inhibitors heats up. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief, including: Actinium, Astellas, Avantgen, Beximco, Capricor, Cytokinetics, Dioscure, Fujifilm, IGM, Immunitybio, Iosbio, Ji Xing, Kaken, Kaleido, Numab, Pharmenable, Regeneron, Roche, Russian Direct Investment Fund, Sosei, União Química Farmaceutica Nacional, United Immunity, Valneva. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Beigene, Gracell, Innovation, Innovent, Moderna, Qilu, Russian Direct Investment Fund, Sesen. Read More