The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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
- Sanofi Bets on Immunotherapy to Delay Onset of Type 1 Diabetes
December 19, 2025
- Japan’s 1st Eylea Biosimilar to Reach Market on January 7
December 19, 2025
- Padcev-Keytruda Pair Makes Mark in Cisplatin-Eligible MIBC: Astellas
December 19, 2025
- Daiichi Sets February Launch for Japan’s 1st OTC Morning-After Pill
December 19, 2025
- Takeda’s TYK2 Inhibitor Scores PIII Win in Psoriasis Trials, Tops Otezla on Key Metrics
December 19, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…