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

Nearly a year and a half after an interim analysis cast doubt on the future of Atara Biotherapeutics Inc.’s phase II study of ATA-188 in treating non-active progressive multiple sclerosis (PMS), the newly released primary analysis didn’t change much. Read More

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

A number of recent developments in artificial intelligence (AI) have sent some reassurance that these algorithms will not hit the market completely devoid of regulation, but a Nov. 8 hearing in the U.S. Senate makes clear that Capitol Hill is intent on legislating on AI, even if only belatedly. 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

New hires and promotions in the biopharma industry, including: Alimera, Century, Metagenomi, Poolbeg, Purminds. Read More

Biopharmas raising money in public or private financings, including: Ascidian, March, Sandoz. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advancell, Aim, Allgenesis, Alterity, Amgen, Arthrosi, Astrazeneca, Bioxcel, Durect, Gilead, HCW, Immatics, Janssen, Lumos, Morphogenesis, Replimune, Takeda. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Century, Eccogene, Eli Lilly, Eqrx, Fujifilm, Invios, Melinta, Oncolytics, Point, Regenxbio, Revolution, Venatorx. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CASI, Samsung. Read More