Serial biotech-founding venture fund Flagship Pioneering Inc., most noted for launching Moderna Inc. in 2012, is crossing into the Asia Pacific (APAC) region and setting up a regional office in Singapore, a move that comes on the heels of its entry into the U.K. earlier this year. Read More
With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier. Read More
The U.S. FDA approved Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib) nearly 20 days ahead of its Nov. 30 PDUFA date for adults with previously treated metastatic colorectal cancer. “Fruzaqla is the first targeted therapy approved in the U.S. for mCRC regardless of biomarker status or prior types of therapies in more than a decade,” Stefanie Granado, head of Takeda’s U.S. Oncology business unit, told BioWorld. Read More
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide). Read More
Legend Biotech Corp. is entering what it no doubt hopes will be another fruitful collaboration with big pharma. Legend’s wholly owned subsidiary, Legend Biotech Ireland Ltd., will work with Novartis AG in an exclusive global development and license agreement for chimeric antigen receptor T-cell therapies targeting DLL3. Read More
October marked a historic milestone for the biopharma industry, with deal values hitting $44.91 billion. It was the highest amount ever recorded by BioWorld, topping a deal value of $42.45 billion in December 2022. While the cumulative value of biopharma deals through Q3 lagged behind the previous year, October’s outstanding value has catapulted this year ahead. In the first 10 months of 2023, deal value reached $175.2 billion, compared to $148.56 billion recorded in the same period in 2022. Read More
Immvira Group Co. plans to progress its intravenous oncolytic herpes simplex virus (oHSV) MVR-T3011-IV to phase II trials after completing a phase I study in the U.S. in patients with late-stage solid tumors. The Shenzhen, China-based company is the first to conduct clinical trials via intravenous administration of oHSVs. Read More
South Korea may soon gain its first domestically developed anthrax vaccine by GC Biopharma Corp., with the Korean biotech having filed Nov. 1 with the MFDS for approval of its novel recombinant protein anthrax vaccine called GC-1109. Read More
Investigators at the Chinese Academy of Sciences have generated a chimeric monkey by injecting an embryonic stem cell into the morula, which is an extremely early embryo consisting of 16 to 32 cells. The animal survived for only 10 days, and it is not the first live birth of a chimeric primate. But it is the first such chimera with contributions from an embryonic stem cell, and that stem cell contributed a far higher proportion of cells in the newborn than have been achieved in previous attempts at creating chimeras. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Araris, Astrazeneca, Eccogene, Kallyope Menarini, Sciclone, Sosei, Texli, Taiho, Wiik. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: CASI Pharmaceutics, Clover Biopharmaceuticals, Daiichi Sankyo, GC Biopharma, Rznomics, Samsung Bioepis, Sanyou Biopharmaceuticals, Sirius Therapeutic, Takeda Pharmaceutical. Read More
