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 Staffers Hid GMP Violations, Fearing Supply Halt: Report
A month after Kyowa Hakko Bio was slapped with an 18-day business suspension order, a group of external lawyers complied a report on their investigation into its GMP violations, revealing that the company’s manufacturing staffers concealed the incompliance for years…
To read the full story
Related Article
- 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 Hit with 18-Day Biz Suspension over GMP Failings
December 25, 2019
- Kyowa Kirin Recalling Mitomycin over Unauthorized Manufacturing Method, Supply Won’t Resume until 2021
October 18, 2019
BUSINESS
- Lilly Confirms Orforglipron Diabetes Filings in US, Japan
August 7, 2026
- Takeda Snares US Approval for Orzeyful in Narcolepsy Type 1
August 7, 2026
- Inrebic Expands First-Line Treatment Options for Myelofibrosis: Expert
August 7, 2026
- Meiji Pharma Drops Hiyasta Development in B-Cell NHL
August 7, 2026
- AstraZeneca Japan Chief Says MFN Response Requires Drug Pricing Reform
August 5, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…