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REGULATORY Xolair Adds Pollen Allergy Use in Japan after 19-Day Delay

December 12, 2019
REGULATORY “Third Price Revision” Eyed for Expansion of Comparator PMP Deduction Rule

December 11, 2019
BUSINESS Healios Poised to Go into the Black with Sakigake-Designated MultiStem, Revs Up Universal Cell Biz

December 10, 2019
REGULATORY Metformin Manufacturers Ordered to Test for Potential Carcinogen Contamination

December 10, 2019
REGULATORY Pharma Industry Might Accept Comparator PMP Deduction If No Eligible Use Added in 6 Years

December 9, 2019
REGULATORY Big 4 Wholesalers Faced Wrath of FTC for Allocating Priority Drug Categories before Bidding

December 6, 2019
COMMENTARY Course of Govt’s “All-Generation” Social Security Reform Could Impact Pharma

December 5, 2019
REGULATORY Average NHI-Market Price Gap at 8.0%, Suspected Bid-Rigging Data Excluded: Chuikyo

December 4, 2019
BUSINESS With Audentes Buyout, Astellas Poised to Position “Genetic Regulation” as 5th Biz Pillar

December 4, 2019
BUSINESS Astellas to Buy Gene Therapy Player Audentes for US$3 Billion

December 3, 2019
REGULATORY Causal Link between Eisai’s Epilepsy Drug and Trial Death Can’t Be Ruled Out: MHLW

December 2, 2019
BUSINESS Stakeholders Rap Big 4 Wholesalers for Bid-Rigging Charges, Say Scandal Shutters Trust in Drug Price Surveys

November 29, 2019
BUSINESS 10-Plus Japan Drug Makers Up FY2019 Guidance on Bullish New Drugs, Mainstays: Tally

November 29, 2019
REGULATORY Amended PMD Law Set for 3-Step Enforcement, 1st Execution Eyed Next Autumn

November 28, 2019
BUSINESS Big 4 Drug Wholesalers Raided on Bid-Rigging Charges

November 28, 2019
REGULATORY Japan’s First Biosimilars of Avastin, Nesp, Forteo Receive Listing

November 27, 2019
BUSINESS Asahi Kasei to Buy Veloxis for 143.2 Billion Yen, Eyes US Transplant Market

November 26, 2019
REGULATORY MOF Panel Leery of Pricey Drugs for Huge Patient Population: FY2020 Budget Recommendation

November 26, 2019
REGULATORY Xolair’s Pollen Allergy Nod Delayed as Novartis Says It Needs More Time to Prepare for Launch

November 25, 2019
REGULATORY MHLW Wants to Ease Unfairness Concerns by Adding New Innovation Gauge to PMP Company Criteria

November 25, 2019

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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…