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REGULATORY
- Prof. Nakamura of Keio Univ. Sees Orphan Drug Development Strategy as Reason for Revised Re-pricing Policy
January 20, 2012
- EMA Initiates Review of Oral MS Treatment Gilenya Following Reports of Heart Problems
January 20, 2012
- PAFSC’s Second Committee on Drugs to Review Kyowa Kirin’s ATL Treatment on February 1
January 19, 2012
- PMDA to Expand PGx, Biomarker Consultation System
January 19, 2012
- MHLW Considering “Partial Introduction” of Medico-Economic Evaluation in FY2014
January 18, 2012
- No Serious Concerns Observed for 4 Vaccines: MHLW Study Groups
January 17, 2012
- US Industry Opinion Divided on Japan’s Participation in TPP Talks
January 17, 2012
- PAFSC’s First Committee on Drugs to Review Zyprexa for Depression in Bipolar Disorder on January 27
January 16, 2012
- MHLW Proposes New Fee for Medical Management of Treatment-Resistant Schizophrenia
January 16, 2012
- MHLW Director Tawaragi Raises 3 Points, Including Risk Management Planning, as Priority Measures for FY2012
January 13, 2012
- MHLW to Strengthen Support for Ultra-Orphan Drug Development
January 13, 2012
- PFSB Calls for Revision of Package Inserts for 15 Products
January 12, 2012
- MHLW Revises Ministerial Ordinance to Prohibit Dispensing Point Services by Pharmacies
January 12, 2012
- MHLW Issues Administrative Notification on Reexamination Period for 8 Products Approved After Partial Changes
January 11, 2012
- MHLW Issues Notification on Change in Clinical Trial Protocols
January 11, 2012
- Nicotine Patch Products Should Remain Class 1 OTC Drugs: PAFSC Subcommittee
January 11, 2012
- JPO Amends Patent Examination GL to Allow Patent Extension for New Formulations Containing Existing APIs
January 10, 2012
- EC Approves Revised Product Labeling for Actos: Takeda
January 10, 2012
- Hyperthyroidism Added to Serious ADR Section of Flolan’s Package Insert
December 28, 2011
- MHLW Commission Says Joint Purchasing an Advantage to Integration of National, Rosai Hospitals
December 28, 2011
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
