Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab).Arexvy became the first…
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REGULATORY
- 73% of Applications for ADR Relief Processed within 8 Months in April-October: PMDA
December 21, 2011
- MHLW Subcommittee Agrees on Mandatory Notification of Package Inserts
December 19, 2011
- DPJ Council Calls on Party Policy Bureau Chairman Opposition to Excessive Decreases in Prices of Long-Listed Drugs
December 19, 2011
- DPJ Approves Social Security Reform Draft, Proposing NHI Price Cuts for Original Drugs
December 19, 2011
- Subcommittee Approves Add’l Price Cut for Long-listed Drugs; Cut for Generics “Can’t Be Ruled Out”
December 19, 2011
- Expert Subcommittee Agrees to 2-Year Continuation of Trial of Premium for New Drug Development
December 19, 2011
- Iressa Osaka High Court Trial Expected to End in January 2012, March Ruling Possible
December 16, 2011
- MHLW Designates Everolimus, 3 Other Products as Orphan Drugs
December 16, 2011
- Public-Private Dialogue to Set Next Strategic Plan for Innovative Drug Discovery
December 15, 2011
- CSIMC Approves Draft Measures to Promote Generic Drug Use
December 15, 2011
- MHLW Notifies of Changes to Precautions for Warfarin Potassium Preparations
December 15, 2011
- ELD Issues Fully Revised GL for Clinical Evaluation of Sleep Medications
December 14, 2011
- Dr Nakamura’s Premature Retirement to Affect “Drug Discovery Support Organization” Project
December 14, 2011
- Government Decides FY2012 Tax Revision Outline, to Extend R&D Tax Break System by 2 Years
December 13, 2011
- Ruling Coalition Prioritizes Economic Evaluation, Other Programs for 2012 Special Budget Quota
December 12, 2011
- MHLW Issues Notification to Change Japanese Pronunciation of “Rivaroxaban” to “Rivah-roxaban”
December 12, 2011
- MOF Asks MHLW for Add’l 10% Price Cut for Long-listed Drugs
December 12, 2011
- Price Cuts for Long-listed Drugs Will Not Promote Generic Drug Use: Korosho in Negotiations with MOF
December 10, 2011
- 11 APIs/26 Products to Return Premium for New Drug Development
December 9, 2011
- MHLW Minister Komiyama Calls on Opposition to Join Efforts to Consider Third-Party Organization
December 9, 2011
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