Latest from Lisa Takagi
Several global products have been granted approval recommendations in Japan, while two Japan-originated drugs received a preliminary nod in their home country after being approved first elsewhere through licensees.
Following US approval of its first-in-class drug for IgAN sibeprelimab, Otsuka is planning an sNDA for an autoinjector in 2026 and is in talks with regulatory authorities in Japan and Europe.
While Japan tries to balance its healthcare costs, the major US industry group is concerned reimbursement pricing practices in the country could influence US levels under Trump's MFN policy.
Plus deals involving Adagene/Third Arc, Celltrion/TRiOar, Celltrion/Kaigene, ImmunoScape/Cue, Laekna/Qilu, Lilly/ABL, Lilly/Sanegene, Sanyou/ZJ Bio-Tech, TransThera/Neurocrine, Qyuns/Roche, Otsuka/4D Molecular, IASO/GC Cell, Chugai/Renalys, Henlius/Forlong and Teijin/Elevara.
Setting its focus on oncology, immunology and rare diseases, the firm anticipates double-digit growth for 2030.
While Astellas and Daiichi Sankyo rang in double-digit growth, Eisai offset LOE impact with Leqembi’s performance. Takeda struggled with negative results but announced several growth initiatives.
