Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: GSK, Johnson & Johnson, Partner, Ribocure, Suzhou Ribo, Sydnexi.
Biopharma happenings, including deals and partnerships, and other news in brief: Biossil, Chugai, Elevara, Maruho, Medivir, Mitocarex, Nanobiotix, Nielsen, Renalys, Scisparc, Secarna, Scenic, Teijin.
Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.