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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REGULATORY
- MHLW Defines “Long-Listed Products” towards Rollout of New Coverage Rule
April 1, 2024
- Kobayashi Factory Inspected over Beni-Koji Health Issue
April 1, 2024
- LDP Lawmakers Call for Penalties against “Dump and Run Away” Generic Makers
March 29, 2024
- Beni-Koji Issue: MHLW Requests Self-Inspections to Purchasers of Kobayashi’s Red Rice Yeast
March 29, 2024
- Label Revision Ordered for CAR-T Therapies to Add New Precaution
March 29, 2024
- Japan PM Vows Early Kick Off of Off-Year Revision Debate at Chuikyo
March 29, 2024
- Japan Diet Passes FY2024 Budget, Record Social Security Spending
March 29, 2024
- MHLW Generic Panel Outlines Plan to Drive Industry Revamp within Specific Time Frame
March 28, 2024
- Japan’s HIV, AIDS Cases Rebound in 2023 after COVID
March 28, 2024
- Japan Govt Launches Panel to Respond to Red Yeast Rice Issue
March 28, 2024
- Japan Approves Piasky, Beyfortus, Broader Use for Abrysvo, and Lot More
March 27, 2024
- PMDA Chief Fujiwara to Remain Skipper for Another Term
March 27, 2024
- PMDA to Build Shared Database of GMP Inspection Reports
March 26, 2024
- Japan Shelves Decision on SanBio’s Lead Cell Therapy on Quality Concerns
March 26, 2024
- Japan’s 1st Eylea Biosimilar Approval on Horizon? JAN Now Decided
March 25, 2024
- Chuikyo Agrees to Exempt PD-1/PD-L1, JAK Classes from Spillover Re-Pricing
March 25, 2024
- Xocova’s Price to Remain Intact after Full Approval, No Change in Clinical Positioning
March 25, 2024
- Japan Set to Push Central IRBs for Clinical Trials, Avoid Customary All-Case PMS
March 22, 2024
- Pharma Regulation Panel Wraps Up Debate, Report to Be Finalized Soon
March 22, 2024
- 1 Year on, China Mulling Potential Indictment of Detained Astellas Employee
March 22, 2024
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The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…
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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…