Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Otsuka Plans US Filing of IgA Nephropathy Drug in H1 2025
Otsuka Pharmaceutical said on November 19 that it will file for US approval of the investigational monoclonal antibody sibeprenlimab for the treatment of adults with IgA nephropathy between January and June of 2025. An interim analysis of the PIII VISIONARY…
To read the full story
Related Article
- Otsuka’s Sibeprenlimab Earns FDA’s Accelerated Nod for IgAN
November 27, 2025
- Otsuka’s Sibeprenlimab Scores Positive Results in PIII: Interim Analysis
June 9, 2025
- Otsuka Files IgA Nephropathy Drug Sibeprenlimab in US
April 1, 2025
- Otsuka’s IgA Nephropathy Drug Makes Mark in PIII, Eyes Accelerated Path
October 23, 2024
- Otsuka’s IgA Nephropathy Drug Gets FDA Breakthrough Tag
February 19, 2024
BUSINESS
- Kyowa Kirin Halts Rocatinlimab Clinical Trials on Malignancy Concerns
March 4, 2026
- Meiji’s Morcamilast Wins EU Orphan Tag for Palmoplantar Pustulosis
March 4, 2026
- Efient AGs Launched Just Ahead of 3-Month Supply Deadline
March 4, 2026
- Takeda Targets Psoriasis Market with Zasocitinib, Touts Edge in TYK2 Selectivity
March 4, 2026
- Sumitomo Regains Growth Momentum, Eyes 350 Billion Yen from 2 Key Drugs in FY2028
March 3, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…