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REGULATORY
- Add Type 1 Diabetes to Opdivo Label: MHLW
November 26, 2015
- Exemption of Clinical Trials in Japanese Subjects Depends on Factors Such as Possibility to Infer Safety: PMDA
November 26, 2015
- Chuikyo Agrees on Setting Range, Not Fixed Threshold, to Judge Cost Effectiveness of Drugs
November 25, 2015
- Don’t Seek Near-Term Profits but Have Long-Term Vision, MHLW Official Tells Drug Makers
November 25, 2015
- MOF Panel Submits Budget Recommendation, Calls for Wrapping Up Talks on Frequency of Drug Price Revisions by Mid-2018
November 25, 2015
- AMED to Allocate 150 Million Yen to Development of In Vitro Diagnostics for Breast and Colorectal Cancer
November 25, 2015
- Generic Prices Should Be Below 50% of Original Drug Prices: Govt Panel Members
November 25, 2015
- MHLW Eyes Using HTA to Re-Price Drugs with Big Sales Outlooks That Have Gone Through 1 or 2 Price Revisions
November 24, 2015
- MHLW OKs Add’l Indications for Lexapro, Other Drugs
November 24, 2015
- Bristol’s MM Drug Elotuzumab Gets Orphan Status
November 24, 2015
- Chuikyo Advisor Submits Guidelines for Cost-Effective Assessments that Would Include Measures Other than QALY
November 24, 2015
- AMED Looks to Bridge “Valley of Death” with Pre-Orphan Designation Scheme
November 20, 2015
- Pharmas Present 9 Requests on Drug Pricing, Tax to LDP Study Group
November 20, 2015
- MHLW Panel Approves Additional Shipment of Kaketsuken’s Venilon, Novact
November 20, 2015
- Viekirax Price, Peak Sales Forecast Called into Question
November 19, 2015
- Chuikyo OKs Viekirax, Other Drugs for NHI Price Listing on Nov. 26
November 19, 2015
- Chuikyo Approves Listing of Temcell and HeartSheet, First Two Regenerative Medicine Products
November 19, 2015
- AbbVie’s Hep C Drug Viekirax Priced at 53,000 Yen Daily vs. Harvoni’s 80,000 Yen
November 18, 2015
- MHLW Cautions against Reference Pricing, Says Impact on Pharmas Would Be Huge
November 18, 2015
- Research-Driven Drug Makers Should Collaborate with Startups, Academia: MHLW Official
November 17, 2015
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