Discussions by the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry structure are reaching the last lap. Its final report - a draft of which will be presented later this month - is expected to…
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- Japan Needs Systemic Reform to Balance Universal Coverage and Access to Pricey Meds: LDP Health Affairs Chief
March 13, 2024
- English Versions of MHLW Biosimilar Trial Guidance, Q&As Now Available
March 13, 2024
- Japan to Simplify Screening for Third-Party Use of Highly Anonymous NDB Data
March 11, 2024
- Consolidate IRBs to Streamline Clinical Trials in Japan: Govt Working Group
March 11, 2024
- Japanese Health Minister Cautions Public on Multiple Measles Outbreaks
March 11, 2024
- PMDA Looks to Rev Up Pediatric and Orphan Drug Initiatives in Next 5-Year Plan: Chief
March 11, 2024
- MHLW Urges Distribution at Fair Price for Unprofitable Products
March 8, 2024
- New Govt Forum to Compile Interim Report to Create Innovation Ecosystem
March 8, 2024
- COVID Vaccine Labels to Be Updated with Booster Use as Main Regimen
March 8, 2024
- Japan Cabinet OKs Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
March 7, 2024
- New Govt Forum for Fighting Drug Loss Should Devise Strategies for Honebuto: LDP Members
March 6, 2024
- Xocova Approval Meaningful, but Careful Use Should Continue: Minister
March 6, 2024
- Opdivo Faces 15% Slash in Spillover, Re-Pricing to Hit 23 Drugs in FY2024 Revision
March 5, 2024
- Drug Prices Cut by 4.67% in FY2024 Revision, 314 APIs to Keep Full Prices with PMP
March 5, 2024
- Shionogi’s COVID Pill Xocova Lands Standard Approval in Japan
March 5, 2024
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 2024
- MHLW to Ask All Generic Makers in Japan to Execute Self-Inspections
March 4, 2024
- Japan’s Revised Drug Distribution Guidelines Take Effect
March 4, 2024
- PMDA Reviewing Safety Risks for 4 CAR-T Therapies and More
March 4, 2024
- Generic Mergers, Product Consolidations Unlikely to Pose Antitrust Issue: FTC Official
March 1, 2024
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The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
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…