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 Sends Alert on Opdivo’s Fulminant Type 1 Diabetes Risk
February 1, 2016
- Suspended-but-Shipped Drugs Should Face 20% Price Cut, Chuikyo Member Says amid Kaketsuken Fuss
January 28, 2016
- MHLW in Final Stages of Study Aimed at Drafting Guidelines on Nucleic Acid Therapeutics; Final Report Due Out FY2016-End
January 28, 2016
- “Huge-Seller” Re-Pricing Created due to Drugs with Huge Financial Impact: Govt
January 27, 2016
- New Basic Guidelines for Hepatitis Measures to Promote Drug Discovery for Hep B
January 27, 2016
- Sakigake Products Added to Scope of Priority Review: MHLW Notification
January 26, 2016
- MHLW Revises GCP Ordinance to Incorporate New Compassionate Use Scheme
January 26, 2016
- Govt Panel Says New Growth Strategy Should Embrace Further Efforts to Fuel Drug Development
January 26, 2016
- PAFSC First Committee to Discuss Add’l Indications for Rituxan, Cymbalta on Feb. 5
January 26, 2016
- Japan Compassionate Use Gets Underway Covering Sakigake-Requested Products, Orphans
January 26, 2016
- MHLW OKs Japan’s First PCSK9 Inhibitor, Other Drugs
January 25, 2016
- Gilead’s 2 Hep C Drugs Likely to Face Some 30% Price Cut under “Huge Seller” Re-Pricing: Jiho Estimate
January 25, 2016
- Sakigake Review System to Shorten Review Time through Greater Efficiency, Not Simplification: Mr Kono of PMDA
January 25, 2016
- PMDA Reviewing Nexium for Risk of Rhabdomyolysis
January 25, 2016
- MHLW Panel on Blood Programs Approves 950,000-Liter Acquisition Target for Raw Plasma in FY2016
January 22, 2016
- Bill Payer Proposes “Penalties through NHI Prices” for Violations of Pharma Law in Wake of Kaketsuken Scandal: Chuikyo
January 22, 2016
- 4 Listed Drugs plus Similar Products Subject to Cost-Effectiveness Review: Chuikyo
January 21, 2016
- Chuikyo OKs New Drug Pricing Rules for FY2016 Reform; Sakigake-Designated Add’l Indications Also Subject to Premiums
January 21, 2016
- MHLW to Designate 617 Products/134 APIs as “Essential Drugs”: Will Receive Uniform, Stable NHI Prices, Exempt from Z2 Rule
January 21, 2016
- “Huge Seller” Re-Pricing to Hit Sovaldi, 3 Other Brands; Hefty 20 APIs Face Regular Market Expansion Re-Pricing
January 21, 2016
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