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The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.

Satsuma Pharmaceuticals, Inc. and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd., announced that five abstracts describing efficacy and safety results from the STS101 Phase 3 clinical study program were selected for presentation at the American Headache Society’s 66th Annual Scientific Meeting.

MiNA Therapeutics today announced a research collaboration and licensing agreement option with Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; Headquarters: Kyoto; President: Toru Nakai), an innovation-driven Japanese-based pharmaceutical company focused on disease areas of high unmet medical need.

In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday.

epitoMAP Inc. and Animal Allergy Clinical Laboratories Inc. entered into a License Agreement for an antibody pharmaceutical for veterinary use, CRE-DR-B, with Nippon Zenyaku Kogyo Co., Ltd. on November 10, 2023.

Vicore Pharma Holding AB, unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists, announced it has entered into an exclusive licensing agreement with Nippon Shinyaku Co. Ltd., a leading Japanese pharmaceutical company, to develop and commercialize Vicore’s drug candidate C21 in Japan.