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 (mCRC). “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. It is also the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status.

Atara retreats from MS as a fail drops the stock

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, the newly released primary analysis didn’t change much. The company’s stock (NASDAQ:ATRA) had dropped significantly by midday, with shares trading 79% lower at 25 cents each. The Embold trial of the Epstein-Barr virus-directed allogeneic T-cell therapy missed its primary endpoint of confirmed disability improvement at 12 months when compared to placebo. Now Atara plans to cut back its ATA-188 development expenses significantly and said it will focus on developing its allogeneic CAR T pipeline.

Flagship launches new offices in APAC, UK to build biotechs overseas

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. “Flagship’s expansion into APAC through our new hub in Singapore, will allow us to accelerate the growth and scaling of our companies and enable us to broaden their impact … through strategic partnerships across industry, academia and health care systems in the region,” said Flagship CEO Noubar Afeyan.

US Senate’s appetite for artificial intelligence legislation expands 

A number of recent developments in the area of artificial intelligence (AI) have sent some reassurance that these algorithms won’t 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. One of the concerns heard during the hearing was that these algorithms can be used to deny payment for treatments prescribed by physicians, but much of the focus of the hearing was on the use of AI to develop biohazards.

1st chimeric monkey born with large embryonic stem cell contribution

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.

Also in the news

Advancell, Aim Immunotech, Alimera, Allgenesis, Alterity, Amgen, Arthrosi, Ascidian, Astrazeneca, Aurinia, Bioxcel, CASI, Century, Durect, Eccogene, Eli Lilly, Eqrx, Fujifilm, Gilead, HCW Biologics, Immatics, Invios, Janssen, Lumos, March, Melinta, Metagenomi, Morphogenesis, Oncolytics, Organon, Point, Poolbeg, Purminds, Regenxbio, Replimune, Revolution, Samsung Bioepis, Sandoz, Takeda, Venatorx, Wave