The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Indoco Remedies, Takeda, Therapeutic Goods Administration, Torrent, U.S. Court of Appeals for the Federal Circuit.
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in exchange for a $10 million up-front payment and as much as $112 million in milestones.
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
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.
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.
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.
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.
HONG KONG – Celltrion Inc. has received conditional marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59), in South Korea. It’s the first company to receive approval for a COVID-19 antibody treatment developed in South Korea, a MFDS spokesman told BioWorld.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: EMA, Therapeutic Goods Administration, U.S. Department of Justice, U.S. Patent and Trademark Office.
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