Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Cervomed, Chiesi, Endeavor, Meitheal, Protalix, Relmada, UCB.
Biopharma happenings, including deals and partnerships, and other news in brief: Amacathera, Boehringer Ingelheim, CDR-Life, Dr. Falk, Evoke, Lakeshore, Merck, Metsera, Novavax, Novo Nordisk, Oceanpine, QOL, Pacira, Pfizer, Sanofi.
Not quite a newco, Alethio Therapeutics has emerged from a period of introspection with new management and a refreshed vision of how best to translate its roots in the biology of chronic, untreatable blood cancers into meaningful therapies.
Celltrion Inc. scored a hat-trick of deals to license new antibody candidates, including a $744 million deal with Kaigene Inc. Nov. 3, and a near $500 million deal with Mustbio Co. Ltd. Oct. 31.
Neok Bio Inc. was formed earlier this year and is already on schedule to file an IND in a few months for its two bispecific antibody-drug conjugates (ADCs) to treat various types of tumors.
Signet Therapeutics founder Haisheng Zhang is betting on organoids and AI to outsmart diffuse gastric cancer and the limits of traditional “clean” drug design.