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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- HSC Subcommittee Agrees on Need for New System to Promote Access to Unapproved Drugs
September 20, 2011
- Price Settlement Rate Down to 73.9% of Sales in June, Close to Pre-emergency Recommendation Levels
September 19, 2011
- New METI Minister Edano Considers Drug Industry as “Highly Promising Area”
September 19, 2011
- FY2011 White Paper Calls For Reform toward “Participatory” Social Security System
September 19, 2011
- PMDA Expresses Distrust of MSD for Deviations from GCP in Trials of Gardasil
September 19, 2011
- Some Medical Institutions Still Demanding Full Payment, No Refund of Clinical Trial Costs
September 19, 2011
- Discussions Continue on Relief System for Victims of ADRs Due to Anticancer Drugs
September 19, 2011
- Preparations Underway for MHLW to Set Up Private Third-Party Committee
September 16, 2011
- Council Recommends 5 Drugs as Appropriate for Application Based on Info. in Public Domain
September 16, 2011
- US FDA Issues Warning Letter Over GMP Violations by Daiichi Sankyo Subsidiary
September 15, 2011
- MHLW to Survey “Family Pharmacy” Function Toward Next Revision of Dispensing Fees
September 15, 2011
- US Proposes Elimination of Tariff on Drugs: TPP Talks
September 14, 2011
- MHLW to Continue to Promote Non-proprietary Name-based Brand Names for GE Drugs
September 14, 2011
- ”GMP Team” to Begin Mock GMP Inspections in Kinki Region from Next February
September 14, 2011
- MHLW Permits Ongoing Internet Sales of Reclassified Class 2 Drugs as Provisional Measure
September 13, 2011
- MHLW Minister Komiyama to Push Drug Industry Development Through Government-Private Sector Cooperation
September 13, 2011
- PAFSC: “No Direct Correlation” Between HPV Vaccine and Reported Death
September 13, 2011
- MHLW Director-General Kikura Indicates “Firm Resolve” for Structural Improvement to Eliminate Drug Disasters
September 12, 2011
- Japan-China Pharma Regulators to Start 4 Projects to Boost Cooperation
September 12, 2011
- Regulatory Strategy Consultation Service “Not Off to a Good Start”: Mr Masuyama of PMDA
September 12, 2011
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A doctor member of the Central Social Insurance Medical Council (Chuikyo) on September 20 traded barbs with pharma leaders over…
The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…
IntroductionCommercial transformation is a top priority for pharma leaders in Japan and rightfully so. In a market with low single…
In the run-up to FY2024 budget requests this summer, there were growing hopes in the pharmaceutical industry that the government's de-facto cap on increases in social security spending would finally be lifted. That did not happen, despite strong calls from…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…