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BUSINESS Kaken President Onuma Targets ¥20 Billion in Operating Profits in 2015

September 21, 2011
ORGANIZATION FPMAJ Seeks Improved System for Orphan Drug Development, Request to Be Submitted Soon to Health Minister

September 20, 2011
REGULATORY HSC Subcommittee Agrees on Need for New System to Promote Access to Unapproved Drugs

September 20, 2011
REGULATORY Preparations Underway for MHLW to Set Up Private Third-Party Committee

September 16, 2011
REGULATORY Council Recommends 5 Drugs as Appropriate for Application Based on Info. in Public Domain

September 16, 2011
BUSINESS Small, Medium-Sized Generic Drug Makers’ Business Improves Amid Uncertainty Over Future

September 15, 2011
BUSINESS Supreme Court Rules Against GE Drug Makers, Allows Patent Extension for Eisai’s Aricept

September 15, 2011
ACADEMIA NCGM Hospital Removes Actos from List of Recommended Drugs in Diabetes Manual

September 14, 2011
ORGANIZATION FPMAJ Announces Its Basic Policy on Providing Info. on Drugs Used Off-label

September 13, 2011
BUSINESS Takeda Initiates PIII Trials of Antidiabetic TAK-875 in Japan

September 13, 2011
BUSINESS NBI Initiates PIII Study for BIBF1122 in Japan

September 12, 2011
REGULATORY MHLW Director-General Kikura Indicates “Firm Resolve” for Structural Improvement to Eliminate Drug Disasters

September 12, 2011
ACADEMIA Clinical Positioning Needs to Be Clarified for Nexavar, Sutent: Prof. Naito of Kyushu Univ.

September 12, 2011
REGULATORY MHLW’s Council to Draw Up 10-Year Strategy for Hepatitis

September 9, 2011
REGULATORY Council Recommends Subsidization of Peginterferon Therapy for Chronic Active Hepatitis B

September 9, 2011
BUSINESS Eisai to Accelerate Clinical Development with Milestone Payments, Signs Agreement on PIII Trials for Lenvatinib

September 8, 2011
REGULATORY CSIMC Introduces New Rule for Pricing of High-Priced Drugs; 10 Drugs to Be Reimbursed on Piecework under DPC

September 8, 2011
REGULATORY Some CSIMC Members Question NHI Pricing of Nexium Priced at Lower Level Than Omepral

September 8, 2011
REGULATORY CSIMC Recommends NHI Price Listing for 15 APIs/20 Products

September 7, 2011
ACADEMIA ”Seller’s Market” for Pharmacists Expected to Continue Over Next Few Years

September 7, 2011

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Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

COMMENTARY

G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands

By Shinya Sato

Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…

COLUMN

The Strategic MSL: Beyond Data Delivery, It’s About Impact

By Philip Carrigan

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…