Atara Biotherapeutics Inc. licensed a pair of mesothelin-directed CAR T treatments, ATA-2271 and ATA-3271, to Bayer AG for $60 million up front with the potential for $610 million in development, regulatory and commercialization milestone payments. Atara is also eligible for tiered royalties that peak in the low double-digit percentage of net sales of the two drugs. South San Francisco-based Atara will provide translational and clinical manufacturing services for the two drugs that will be reimbursed by Bayer. Read More

New data on a variety of blood disorder therapies announced at the 62nd American Society of Hematology (ASH) annual meeting moved company shares on Dec. 7. Shares of Fate Therapeutics Inc. (NASDAQ:FATE) hit a record high, rising 37.8% to $83.77 by day's end on news of clinical activity for one candidate in refractory diffuse large B-cell lymphoma. Read More

Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals. Read More

It’s official. After a weekend of rumors and speculation, President-elect Joe Biden formally announced the nomination of California Attorney General Xavier Becerra Dec. 7 as secretary of the U.S. Department of Health and Human Services, along with Vivek Murthy as surgeon general. Read More

TOKYO – Steadily over a decade and a half, Japan’s drugs and devices regulator has all but eliminated a huge drug lag that put the second largest drug market in the world well behind most others in terms of the time it took for approvals and patient access to innovative drugs. Read More

The latest global regulatory news, changes and updates affecting biopharma, including: FDA, industry prepare for vaccine; FDA updates trial guidance; Labeling changes for diabetes drugs. Read More

BioWorld looks at translational medicine. Read More

A quick look back at top stories. Read More

New hires and promotions in the biopharma industry, including: Achilles, Avadel, Bellus, Chimeron, GBT, Oncorus, Oyster Point, Rexgenero. Read More

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology’s annual meeting, Dec. 5-8, including: Actinium, Allogene, Allovir, Amgen, Amphivena, Apellis, Arch Oncology, Astrazeneca, Attralus, Autolus, Beigene, Bergenbio, Biocryst, Bioniz, Bluebird, BMS, Cellectis, Constellation, Corvus, Crispr, Fate, Fulcrum, Gamida, GBT, Genentech, Gilead, Glycomimetics, IGM, Immunogen, IMV, Intellia, Janssen, Kite, Kura, Lilly, Macrogenics, Magenta, Orca Bio, Poseida, Regeneron, Rhizen, Rocket, Syndax, Syros, Vertex, Viracta. Read More

Biopharmas raising money in public or private financings, including: 4D Molecular, Abcellera, Basking, Biocryst, Cogent, Enliven, Helix, Intellia, Nanobiotix, Repligen, Sinovac, Spirea, Trianni. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 9 Meters, Alx, Arch Oncology, Arcturus, Arcutis, Brickell, Cel-Sci, Cytokinetics, Dare, Eisai, Genetx, Hookipa, Inovio, KPB, Lyra, Magenta, Neurorx, Odonate, Relief, Relmada, Sarepta, Tonix, Ultragenyx, Ysopia. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3D Med, Accord Healthcare, Adelia, Aeterna, Aligos, Alloy, Astellas, Aurigene, Bioxcel, Boehringer, Bridgebio, Catalent, Consilient, Cybin, Exelixis, Eyam, Genscript, Gilead, Initium, Janssen, Kalivir, Marinus, Matinas, Maze, Menarini, Merck, Moderna, Nabriva, Orexo, Orsenix, Passage Bio, Pfizer, Postera, Proxygen, Qilu, Roivant, Sellas, Seqirus, Sesen Bio, Sherlock, Sinovant, Syneos, Syros, VBI, Xencor. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Alzecure, Antengene, Artiva, Chimerix, Immunicum, Kronos, Lipocine, Neuren, Novo Nordisk, Scpharmaceuticals, Scynexis, Sol-Gel, Viracta, Yiling. Read More