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.
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.
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.
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.
HONG KONG – Tapping into synergies it sees between the U.S. and Chinese biotech industries, Suzhou, China-based Ascentage Pharma Group International is aiming to get its most advanced candidate, HQP-1351, to market this year.
CAJICA, Colombia – Brazil's Butantan Institute and the government of the state of Sao Paulo released efficacy results on Jan. 7 for Coronavac, developed by China’s Sinovac Biotech Ltd., that suggest the COVID-19 vaccine is more than 78% effective.
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