Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
All FAD Agents in Japan to Be Discontinued as Kyowa Hakko Bio Quits API Production
Five Japanese drug makers said on June 6 that they will discontinue sales of 13 products containing flavin adenine dinucleotide (FAD) as Kyowa Hakko Bio will cease the manufacturing of their APIs in FY2023 - the latest fallout from GMP…
To read the full story
Related Article
- 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 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
- Kyowa Kirin Halts Rocatinlimab Clinical Trials on Malignancy Concerns
March 4, 2026
- Meiji’s Morcamilast Wins EU Orphan Tag for Palmoplantar Pustulosis
March 4, 2026
- Efient AGs Launched Just Ahead of 3-Month Supply Deadline
March 4, 2026
- Takeda Targets Psoriasis Market with Zasocitinib, Touts Edge in TYK2 Selectivity
March 4, 2026
- Sumitomo Regains Growth Momentum, Eyes 350 Billion Yen from 2 Key Drugs in FY2028
March 3, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…