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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- MHLW to Make Case-by-Case Decisions on Use of “Specified Clinical Research” Data in Regulatory Filings
April 6, 2023
- Expert Panel Questions Requirement for Generic Listing in All Versions
April 5, 2023
- Expert Panel Mixed on Macroeconomic Indexing of Drug Cost; Govt Urged to Quit Targeting Pharma for Savings
April 5, 2023
- Japanese Embassy Official Meets Astellas Employee Detained in China
April 5, 2023
- Antibiotics against CRE Chosen for Japan’s Revenue-Guarantee Pilot Project
April 5, 2023
- Health Minister Vows Transparency in Vaccine Purchase after Audit Report
April 4, 2023
- MHLW Issues Guidance on eConsent in Clinical Trials
April 4, 2023
- Japanese Foreign Minister Demands Release of Man Detained in China
April 3, 2023
- 32 Hypertension Meds under PMDA Safety Review for Women of Childbearing Potential
April 3, 2023
- Suprapartisan Lawmakers’ League Discussing Bill to Establish Dementia Law
March 31, 2023
- LDP League Asks Health Minster for Proper Insurance Coverage for Patches
March 31, 2023
- AMED’s “CANNDs” Set for Full Rollout in FY2023, but Panel Members Want Wider Range of Data to Fuel Drug Discovery
March 31, 2023
- Audit Questions Rationale for Order of 882 Million COVID Vaccine Doses
March 30, 2023
- Japan to Allow Drone Deliveries of Drugs When Appropriate, Including Powerful Meds
March 29, 2023
- Panel OKs 3 Products for 1st SaMD Priority Review Designations
March 29, 2023
- Japan Diet Enacts Record Budget for FY2023
March 29, 2023
- Ipsen’s Fidrisertib, Chugai’s Faricimab and 2 More APIs Get Orphan Tags in Japan
March 29, 2023
- Japan’s Foreign Minister Likely to Visit China Soon, Demand Citizen’s Release
March 29, 2023
- Japan Approves Wegovy, Omvoh, FluMist, Entyvio SC and More
March 28, 2023
- 5 Wholesalers Ordered to Pay 627 Million Yen in Surcharge over Kyushu Bid-Rigging
March 27, 2023
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