Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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- Parexel Exec Says FDA Keeps Reviews on Track amid Staff Cuts, but Notes Leadership Drain
September 30, 2025
- China Approves Monthly IV Maintenance Dosing of Leqembi
September 30, 2025
- Enhertu Outperforms Kadcyla in PIII Breast Cancer Trial
September 30, 2025
- Alfresa, Hiroshima Univ. Hospital Begin Talks on SFTS Collaboration
September 30, 2025
- Industry Fears Trump’s MFN Drug Pricing Push Could Deepen Japan’s Lag and Loss
September 29, 2025
- Riken Genesis CDx Earns Japan Nod for Truqap Combo Therapy
September 29, 2025
- Meiji Rolls Out 2-Dose Vial of COVID-19 Vaccine Kostaive
September 29, 2025
- Mochida Sees Domestic Biosimilar Supply Gains in And Pharma Tie-Up
September 26, 2025
- Fujifilm Launches US$3.2 Billion Biologics Plant in North Carolina
September 26, 2025
- MEDRx/DWTI Clinch US FDA Approval for Lidocaine Patch
September 26, 2025
- Nippon Zoki Shooting for 50% Overseas Sales by FY2035
September 25, 2025
- Australia Clears Leqembi after Tribunal Review
September 25, 2025
- Taiho Hooks Up with Guardant Health in Biomarker Search
September 25, 2025
- GE HealthCare to Develop Lantheus’ Prostate Cancer PET Agent in Japan
September 25, 2025
- Eisai Settles US Lenvima Suit with Dr. Reddy’s, Generic Launch Barred Until 2030
September 25, 2025
- Enhertu Combo Accepted for US Review in First-Line HER2 Breast Cancer
September 25, 2025
- Chugai Seeks Avastin Label Expansion for Neurofibromatosis Type 2
September 25, 2025
- Mochida and Itochu to Each Take 20% Stake in And Pharma
September 24, 2025
- PharmaEssentia Files for ET Indication of Besremi in Japan
September 24, 2025
- FDA Turns Down Otsuka’s PTSD Bid for Rexulti
September 24, 2025
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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…