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REGULATORY (Update) NHI-Market Drug Price Gap at 9.1%, 7.1% Regular Price Cut Expected in FY2018

December 6, 2017
REGULATORY NHI-Market Drug Price Gap at 9.1%, 7.1% Regular Price Cut Expected in FY2018

December 6, 2017
REGULATORY Novo’s Semaglutide Stumbles as Panel Puts a Hold on Japan Approval

December 5, 2017
REGULATORY CEFP Members Want Quicker Cuts for Off-Patent Drugs, Pricing Debate Enters Final Stretch

December 4, 2017
BUSINESS Ayumi Looks to Haul in Over 10 Billion Yen from 3 RA Biosimilars: President

December 1, 2017
REGULATORY Japan, US, Europe Trade Groups Forge United Front against Govt PMP Plan, Supportive of Negative List: Chuikyo

November 30, 2017
BUSINESS Japan’s 1st Rituxan Biosimilar to Arrive Soon, Sandoz Confident on Market Acquisition

November 29, 2017
REGULATORY New Plan Would Reduce Number of PMP-Eligible Products by 40-50%: MHLW Estimate

November 29, 2017
BUSINESS Tagrisso Filed for 1st-Line EGFR-Mutated NSCLC in Japan: AZ

November 28, 2017
ORGANIZATION PhRMA Japan Chief “Shocked” by Govt’s PMP Plan, Doesn’t Want It Institutionalized as Proposed

November 27, 2017
REGULATORY Draft Outline of Drug Pricing Overhaul Unveiled at Chuikyo; De-Facto Shrinkage for Price Maintenance Scheme Proposed

November 24, 2017
REGULATORY Chuikyo Agrees to Define Scope of Off-Year Re-Pricing by 2020-End for 1st Off-Year Revision in April 2021

November 22, 2017
TRENDS Large Gap in Performance of New Drugs; Products Including Clenafin, Uptravi Doing Well

November 22, 2017
BUSINESS Pfizer Begins Submitting Applications for Biosimilars, Could Be First Major New Drug Maker to Enter Japanese Market

November 21, 2017
REGULATORY Govt Plans to Apply 5 Price Bands for Listed Generics in “Off-Year” Revisions, Maintain 50% Rule for 1st Generics in April

November 20, 2017
REGULATORY Govt Plans Tiered PMP for Smaller Scope of Products, Post-Z2 Rule for LLPs

November 17, 2017
BUSINESS Transfer of LLPs from Chugai “Our Ticket to Admission” into Pharma Business: Taiyo Pharma COO

November 16, 2017
REGULATORY Chuikyo OKs Bavencio, Maviret, Ibrance and More for Listing on Nov. 22

November 15, 2017
ORGANIZATION Deeper Price Cuts Needed for Off-Patent Brands, Scrap 5-Year Grace Period: Chuikyo Payer Rep

November 14, 2017
REGULATORY Pilot CEA Program: Company Data, Third-Party Re-Analysis Data Show Big Gaps for Some Products

November 13, 2017

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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…