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REGULATORY
- Humanitarian Trial Data Will Be Supplementary Reference to Confirmatory Studies: Govt
October 5, 2015
- Chuikyo Approves Draft Framework for Patient-Initiated Mixed Care; Will Establish Evaluation Council by Next Spring
October 2, 2015
- PAFSC Committee Approves Resumed Shipments of Kaketsuken’s Venilon due to Potential Shortage of Substitutes
October 2, 2015
- Drug Pricing Organization to Price JCR’s Cell Therapy Temcell
October 1, 2015
- JPWA Calls for Fair Sharing of Distribution Costs for Premium-Granted Products
October 1, 2015
- Chuikyo Debate Heats Up on Number of Generic Brands, Makers; JGA Floats New 3 Price-Band Rule
October 1, 2015
- Generic Drug Prices in Japan “Not Necessarily High” Compared to Other Countries: Pres. Yoshida of JGA
October 1, 2015
- 2 Firms Mulling Confidentiality Accords to In-License 1st Drug Seed via AMED
September 30, 2015
- Editor’s Pick: Five Healthcare News Headlines for September 14 - September 27
September 29, 2015
- MHLW Gives Greenlight to AbbVie’s Hep C Drug, Other Products
September 29, 2015
- Health Policy Bureau Chief Futagawa Tapped for MHLW’s Top Bureaucratic Post
September 28, 2015
- PMDA Reviewing Daklinza, Sunvepra for Risk of Interstitial Pneumonia
September 28, 2015
- MHLW OKs New Indications for Xarelto, Lamictal, Other Products
September 25, 2015
- Drug Pricing Tomorrow: Full Interview with MOF Budget Examiner Unami
September 25, 2015
- One-Month Lag in Regulatory Filing Accepted for Sakigake Designation
September 24, 2015
- Pharmaceutical Affairs Council Approves Basic Plan for “Humanitarian Trials”
September 24, 2015
- Panel OKs Revised Japanese Pharmacopoeia, 76 Products Newly Included
September 18, 2015
- MHLW to Continue to Suspend HPV Vaccine Recommendation
September 18, 2015
- 51 Products Officially Filed for Sakigake Designation after MHLW Screening
September 18, 2015
- Add Myasthenia Gravis, Myositis to Opdivo Label: MHLW
September 17, 2015
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