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
- 2-Year Extension OK’ed for Raise on R&D Tax Credit Rates, Ceiling: LDP Subcommittee
December 9, 2020
- MHLW Estimates: Off-Year Re-Pricing with Average Price Gap Threshold Likely to Hit 8,700 Products, Save 360 Billion Yen
December 9, 2020
- MHLW Ordered Label Revisions for 5 Drugs Including Alexion’s Soliris
December 9, 2020
- Adrenomedullin, Baricitinib Added to MHLW’s COVID-19 Guide
December 8, 2020
- MHLW Panel OKs Takeda’s ALK Drug, Lynparza’s Pancreatic Cancer Use; Seikagaku’s Osteoarthritis Med Put under Continued Review
December 7, 2020
- Gardasil’s Male Indication in Line for OK as Early as This Month
December 7, 2020
- Russia Willing to Transfer Tech to Japan If Its COVID-19 Vaccine Approved: Envoy
December 7, 2020
- PM Remains Mum on Expected Timeline for Vaccination Start in Japan
December 7, 2020
- PMDA to Continue Remote GCP/Compliance Inspections through June Next Year
December 7, 2020
- FY2021 Draft Budget Guidelines Say to “Appropriately Work On” Off-Year Re-Pricing: LDP Health Panel
December 4, 2020
- MHLW Aware of Challenges in Drug Price Formation in COVID-19-Hit Market: Official
December 4, 2020
- Yescarta Sails through PAFSC Review; Panel Roughly OKs Novartis’ Corrective Measures after Zolgensma Delay
December 4, 2020
- MHLW Hears Independent Monitoring Panel’s Views on “Periodic Reports”; Will Submit Proposal at Next Meeting
December 4, 2020
- Wholesalers’ Deteriorating Earnings Attributed to Compounding Reasons: JPWA
December 3, 2020
- Lilly’s Galcanezumab Clears PAFSC Review, 1st Antibody for Migraine Prevention
December 3, 2020
- Finance Minister Pushed for All-Product Re-Pricing in 2021: CEFP Minutes
December 3, 2020
- Chuikyo Reps Raise No Opposition to Off-Year Re-Pricing, Still Split over Product Scope
December 3, 2020
- MHLW to Issue Notification to Urge Drug Makers’ Prompt Info Provisioning on Supply Shortages
December 3, 2020
- Japan Diet Clears Immunization Bill
December 2, 2020
- Japan’s Volume-Based Generic Share 78.3% in September, Fails to Hit Govt Goal
December 2, 2020
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Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…