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REGULATORY
- Opdivo under PMDA Review for Myocarditis and Other Risks
September 26, 2016
- Council Conditionally Approves 1st Technology for Use Under Patient-Initiated Mixed Care at Univ. of Tokyo Hospital
September 26, 2016
- Pharma, Govt Hold 1st Kanmin Taiwa Working Group Talks; Industry Calls for Trial-Friendly Environment, Discussions on Pricing
September 23, 2016
- Panel Backs Approval of Add’l Indication for J-TEC’s Cell Sheet JACE
September 21, 2016
- Combo Use of 2 Different Hep B Vaccines Produced Necessary Antibody Titer, No Serious ADRs: Report
September 21, 2016
- AMED Official Outlines Pre-Orphan Designation Support Scheme
September 20, 2016
- 3 Major Regulators Will Cooperate on Common Guidelines for Development of Antibacterial Drugs: PMDA Official
September 20, 2016
- As Personal Info Law Amendment Looms, Govt Official Tells Drug Makers to Review Info in Hand
September 16, 2016
- International Meeting of World Pharmacopoeias OKs GPhP Draft
September 16, 2016
- In-Kind Research Support Would Be Effective in Commercializing Drug Seeds: Paper
September 15, 2016
- FY2015 Japan Drug Spending Up 11% on Hep C Meds
September 15, 2016
- Industry Chiefs, Chuikyo Panelists Trade Barbs over Market Expansion on Add’l Indications
September 15, 2016
- 3 Pharma Groups Firmly Oppose Out-of-Cycle Re-Pricing at Chuikyo
September 15, 2016
- G-CSF Preparations Ordered to Add Anaphylaxis in ADR List
September 14, 2016
- Blue Book “Will Be Used as Reference When Selecting Generics”: Panel Chair
September 14, 2016
- PMDA, FDA, EMA Agree on 6 Regulatory Approaches on AMR
September 13, 2016
- G7 Health Ministers Adopt Kobe Communique
September 13, 2016
- Generics from 5 Companies Enough When Major Products Lose Patent Protection: Top Bureaucrat
September 13, 2016
- Kaketsuken “Should Seriously Reflect” on Its Conduct before Asking for Permission to Continue Business: Health Minister
September 12, 2016
- MHLW Panel Backs Approval of Pembrolizumab, Some Voice Concerns for Its High NHI Price
September 12, 2016
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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…
