Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Otsuka’s Sibeprenlimab Earns FDA’s Accelerated Nod for IgAN
Otsuka Pharmaceutical said on November 26 that its first-in-class APRIL-directed antibody Voyxact (sibeprenlimab) received accelerated approval from the US FDA on November 25 for the treatment of adults with primary IgA nephropathy. The antibody is the world’s first APRIL-targeting therapy,…
To read the full story
Related Article
- Otsuka’s Voyxact Shows Two-Year Kidney Benefit in PIII IgAN Trial
July 3, 2026
- Otsuka’s IgA Drug Voyxact Sees Strong US Uptake: EVP
April 30, 2026
- 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 Plans US Filing of IgA Nephropathy Drug in H1 2025
November 20, 2024
- 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
- Sanofi Delays Japan Launch of Efluelda by One Year, Defers NIP Rollout
July 22, 2026
- Takara Bio to Transfer Cell Processing CDMO Biz to S-RACMO
July 22, 2026
- Takara Bio Voluntary Buyout Draws 148 Employees
July 22, 2026
- Rhythm Pharma Gears Up for First Japan Launch with 50-Strong Team
July 21, 2026
- Fujifilm Toyama Chemical Forms 1st Product-Dedicated Unit for Savyscus
July 21, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…