Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Voyxact PIII Data Confirm Kidney Function Stabilization in IgAN
August 5, 2026
- Otsuka’s Voyxact Shows Two-Year Kidney Benefit in PIII IgAN Trial
July 3, 2026
- 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
- Terumo to Take US$610 Million Hit as CSL Plasma Supply Deal Ends
October 9, 2026
- TOPIX Shuffle Puts Mid-Tier Drug Makers, Wholesalers on Chopping Block
October 9, 2026
- Ono Gets Japan, Asia Rights to 3 IgG Degraders from Biohaven
October 9, 2026
- Datroway Snares TNBC Approval in China: Daiichi Sankyo
October 9, 2026
- Enhertu Gains Adjuvant Nod in China for HER2-Positive Breast Cancer
October 9, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…