Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes. Read More
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod. Read More
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. Read More
PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved. Read More
PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates. Read More
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans. Read More
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia. Read More
PERTH, Australia – Startup Currus Biologics Pty Ltd. has launched with a AU$10 million (US$7.5 million) series A round with the mission of improving the success of CAR T-cell therapies against solid tumors such as breast, ovarian and pancreatic cancers. Read More
A new regulatory agreement could give Indonesia greater access to newer drugs and Chinese companies greater market share in Southeast Asia’s largest market. Read More
Sometimes, scientific progress comes from conceptual insights that arrive in a flash. More often, however, such progress arrives in a decidedly less glamorous, though no less important, manner. Read More
Data presented at the 81st Scientific Sessions of the American Diabetes Association, including: Beijing Cosci-Remd, Remd Biotherapeutics, Scohia. Read More
Data presented at The International Liver Congress – The Annual Meeting of the European Association for the Study of the Liver, including: Brii Biosciences, VBI Vaccines. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: Beigene, Biocytogen, Genfit, Hutchmed, Orum, Sanyou, Strand, Triastek. Read More
