PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Astrazeneca Pty Ltd. for its COVID-19 vaccine, a recombinant adenovirus vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia, following the Jan. 26 provisional approval for Pfizer Australia Pty Ltd.’s COVID-19 vaccine, branded Comirnaty. Read More
Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization. Read More
HONG KONG – Ono Pharmaceutical Co. Ltd. has agreed to pay Ribon Therapeutics Inc. as much as ¥15.4 billion (US$147.3 million) for exclusive rights to develop and commercialize the company’s phase I PARP7 inhibitor RBN-2397 for the treatment of solid tumors in Japan, South Korea, Taiwan and ASEAN countries. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year. Read More
HONG KONG – A Japanese phase III study of Chugai Pharmaceutical Co. Ltd.’s interleukin-6 inhibitor Actemra (tocilizumab) in patients hospitalized with severe COVID-19 pneumonia has read out, expanding what’s known about the drug’s use in the pandemic, which had been inconclusive until recently, though is now known to reduce mortality in the vulnerable population. Read More
BioWorld tracked a total of 295 phase I, II and III clinical news items in January, a rise of 39% compared with the number recorded during the pre-pandemic month of January 2020. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: Adagene, Bionomics, Drug Farm Holding, Medincell, Neox, Neurophth. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Algernon, Neurorx, Takeda, Tessa, Turn, University of Oxford. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Astrazeneca, Biontech, China Oncology Focus, Clinuvel, Curevac, Eli Lilly, I-Mab, Immunitybio, Moderna, Nantkwest, Oxford University, Pfizer, Russian Direct Investment Fund, Sorrento, Takeda, Triastek, University of Oxford. Read More
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: FDA, Fresenius Kabi Oncology, Therapeutic Goods Administration, U.S. Department of Justice. Read More
