Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Meiji, Again, Halts Supply of Kobayashi Kako-Made Drugs after On-Site Inspections
Meiji Seika Pharma said on December 22 that it will temporarily stop the shipment of 13 APIs/43 products manufactured by Kobayashi Kako after health and prefectural authorities started on-site inspections into the partner’s manufacturing practices. Meiji had halted shipments to…
To read the full story
Related Article
- Meiji to Discontinue Sale of Kobayashi Kako Products after Biz Suspension
February 26, 2021
- 2nd Death Reported for Tainted Itraconazole User, Doctor Says Causal Link Unlikely
December 18, 2020
- Kobayashi Kako Manually Managed Itraconazole Production; Hand-Written Record on Rilmazafone Mix-Up Found
December 17, 2020
- Industry Sees Flip-Flops on Supplies of Kobayashi Kako-Made Products
December 16, 2020
- Kobayashi Kako Temporary Halts Shipments of All Products after Tainted Itraconazole Issue
December 15, 2020
BUSINESS
- Half of Drug Makers Reluctantly Support G1 Rule Overhaul: Jiho Survey
March 12, 2026
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…