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
- Annual Savings from Biosimilar Use Totaled Just 14.6 Billion Yen: MHLW
August 21, 2019
- Prices Go Up for 37% of Drugs, Down or Intact for 63% in Tax Hike Re-Pricing
August 20, 2019
- Kymriah, All Checkpoint Drugs but Tecentriq to Get Price Maintenance Premium in October Re-Pricing
August 20, 2019
- Rituxan’s Orphan Status Dropped for Rare Blood Disorder
August 16, 2019
- Japan’s 1st Forteo Biosimilar Could Get Listed in November
August 16, 2019
- First “Post-Nesp” Renal Anemia Med Could Land Japan Approval in September
August 16, 2019
- AbbVie’s Venetoclax Up for Review on Aug. 23; Tecentriq’s Breast Cancer Use, 2nd Biosimilars Also on Agenda
August 16, 2019
- Japan OKs Zetia Generic, Possibly AG, towards December Listing; No Entry for Lyrica This Time
August 16, 2019
- MHLW to Announce New Drug Prices on Aug. 19
August 9, 2019
- MHLW Gives Update on Heptavax, Seeks Cooperation in Stable Hep B Vaccine Supplies
August 8, 2019
- MHLW Compliance Chief Stresses Priorities on PMD Law Amendment, Steady Implementation of Detailing Guidelines
August 8, 2019
- MHLW Begins Discussions on Clinical Use of Human-Embryo Gene Editing
August 5, 2019
- MHLW Pharma Bureau Chief Keen on Early Enactment of PMD Amendment Bill
August 5, 2019
- Tecentriq’s SCLC Use Gets MHLW Panel Nod for September Approval
August 5, 2019
- Cost-Effectiveness Challenge Remains in Adding Rotavirus Vaccine to Public Vaccination Programs: MHLW Panel
August 5, 2019
- Nobelpharma’s Tympanic Membrane Perforation Drug Clears MHLW Panel, September OK Likely
August 2, 2019
- MHLW Finalizing Timing to Announce Post-Oct. 1 NHI Prices, Bureau Chief Hints at August Possibility
August 2, 2019
- Japan OKs FY2020 Budget Guidelines, Sets 530 Billion Yen Request Ceiling for Social Security Cost Rise
August 1, 2019
- Indonesia to Shorten Review Period for Japan-Approved Drugs
July 29, 2019
- Chuikyo to Revisit Generic Price-Band Rule
July 26, 2019
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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…