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 Selects 9 Priority Prefectures for Generic Promotion Project, but Leaves Tokyo Out
July 12, 2018
- Generic Makers Should Shift to Biologics Biz for Survival: MHLW Official
July 11, 2018
- MHLW Official Expounds on “Authorized Biosimilar” Pricing, 50% Generic Rule Applies for “Biosame” Products
July 11, 2018
- Cabinet OKs FY2019 Budget Guidelines, Allows Request for 600 Billion Yen Social Security Cost Rise
July 11, 2018
- Prices for High-Cost Techs Will Settle Down as They Penetrate Market with Public Health Coverage: MHLW Bureau Chief
July 10, 2018
- Tokyo Govt to Launch Support Program for Drug Discovery Startups to Solve Obstacles to Fundraising, IP Strategy
July 10, 2018
- Reduce Dose, or Discontinue Biologics for Patients with Low RA Disease Activity: Report
July 9, 2018
- Govt Dodges Lawmaker Inquiry on Timing of 2019 Drug Price Revision
July 9, 2018
- LDP Lawmakers to Sort Out Life Science Issues over This Summer
July 6, 2018
- Council OKs Public Knowledge-Based Submissions for New Azathioprine, Temozolomide Indications
July 5, 2018
- Govt Likely to Allow 600 Billion Yen Rise for FY2019 Social Security Budget Request
July 4, 2018
- Several Brand-Name Drug Makers Intend to Withdraw “G1” LLPs
July 4, 2018
- LDP Lawmakers Launch New Study Group on Life Science Industry
July 3, 2018
- MHLW OKs 1st Pfizer Biosimilar, Add’l Indications and Dosages
July 3, 2018
- MHLW Approves Entyvio, Imfinzi, Lynparza Breast Cancer Use, and More
July 3, 2018
- PMDA Reveals First 2 Cases of MID-NET Regulatory Use
July 2, 2018
- LDP’s Patch Panel Boots Up with Bigwig Noda as Chairman
June 28, 2018
- MHLW to Remove Pregnancy Contraindication for 3 Immunosuppressants
June 27, 2018
- Ryukaikon Working Group to Discuss Rebates Offered to Make Up for Higher Invoice Prices
June 26, 2018
- New LDP Study Group to Kick Off with Focus on Innovation in Life Science
June 25, 2018
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
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…