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REGULATORY First “Post-Nesp” Renal Anemia Med Could Land Japan Approval in September

August 16, 2019
REGULATORY Japan OKs Zetia Generic, Possibly AG, towards December Listing; No Entry for Lyrica This Time

August 16, 2019
TRENDS Chugai Running Offensive/Defensive Play towards EPS Growth Goal, Hemlibra Outpaces Target

August 9, 2019
BUSINESS Sumitomo Dainippon Going Full Tilt for Napabucasin Colorectal Cancer Trial after Pancreatic Flop

August 8, 2019
BUSINESS Novartis’ Entresto Filed in Japan for Chronic Heart Failure

August 7, 2019
BUSINESS Gearing Up for Japan Debut, Daiichi Sankyo Mounting Push for AML Med Vanflyta

August 6, 2019
REGULATORY MHLW Pharma Bureau Chief Keen on Early Enactment of PMD Amendment Bill

August 5, 2019
REGULATORY Tecentriq’s SCLC Use Gets MHLW Panel Nod for September Approval

August 5, 2019
REGULATORY MHLW Finalizing Timing to Announce Post-Oct. 1 NHI Prices, Bureau Chief Hints at August Possibility

August 2, 2019
BUSINESS Takeda Squeezes Projected Losses for FY2019 as Velcade Copy Lags

August 1, 2019
BUSINESS Crushing Defeat or Sign of Hope? Analyst, KOL Give Mixed Views for CheckMate-227

July 31, 2019
BUSINESS Mitsubishi Tanabe’s Sales Fall 6.9% as Gilenya Snafu Takes Toll

July 30, 2019
BUSINESS Nesp Biosame to Hit Japan Shelves on August 5

July 29, 2019
BUSINESS Chugai Nets 40%-Plus Profit Rise, but Keeps 3-Year EPS Target; President Nixes Avastin Biosame

July 26, 2019
REGULATORY Industry’s Plea to Scrap PMP Company Criteria Gets Cold Shoulder at Chuikyo

July 25, 2019
BUSINESS Ayumi to Ease Restrictions on Enbrel Biosimilar Use as Product Boost Progresses

July 24, 2019
REGULATORY 3 Pharma Groups Push Chuikyo to Expand PMP Coverage, Scrap Company Criteria

July 24, 2019
BUSINESS Boehringer Said to Consider Nixing Allowances for Some Wholesalers, Denies Intention to Narrow Distributors

July 23, 2019
REGULATORY MHLW Panel to Review Tecentriq’s SCLC Use and More for September OK

July 23, 2019
BUSINESS Nitto Pharma Accelerating Development of Gut Bacteria Drugs, Eyes Clinical Studies within 3 Years

July 22, 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…