Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Kyowa Hakko Bio Hit with 18-Day Biz Suspension over GMP Failings
Kyowa Hakko Bio’s ethical drug manufacturing division was ordered to suspend its business for 18 days starting on December 25 after the company was found to have manufactured 18 API/additive products with an unauthorized method in violation of GMP regulations.…
To read the full story
Related Article
- Kyowa Kirin Files Intas-Licensed Mitomycin for Cancer Use in Japan
October 19, 2022
- All FAD Agents in Japan to Be Discontinued as Kyowa Hakko Bio Quits API Production
June 9, 2022
- Kyowa Hakko Bio’s GMP Breach Triggers Shipment Curbs, Stockouts at Astellas, Kowa; Impact Could Reverberate Further
June 3, 2020
- Kyowa Hakko Bio Staffers Hid GMP Violations, Fearing Supply Halt: Report
February 4, 2020
- Kyowa Kirin Recalling Mitomycin over Unauthorized Manufacturing Method, Supply Won’t Resume until 2021
October 18, 2019
BUSINESS
- GNI Targets Above-Industry Growth in Japan after Ayumi Buyout
July 3, 2026
- Sawai Prevails in ALS Drug Contract Appeal against Neugen
July 3, 2026
- Insilico, Takeda Ink AI Drug Discovery Deal Worth Up to US$600 Million
July 3, 2026
- Otsuka’s Voyxact Shows Two-Year Kidney Benefit in PIII IgAN Trial
July 3, 2026
- PeptiDream, NCC Start FIH Study of CLDN18.2 Radiopharmaceutical
July 3, 2026
The number of newly listed generic drugs in Japan has fallen sharply over the past decade, reflecting structural changes in…
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…