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REGULATORY
- Revamped Sakigake Pricing Premium to Grant Maximum Premium Rate of 20%: Chuikyo Subcommittee
December 3, 2015
- Interstitial Pneumonia Added to ADR List for Daklinza, Sunvepra
December 2, 2015
- MHLW Discussing Use of Disease Registry as Substitute for Control Groups; Could Be “One Means of Evaluation” in Trials for Rare Diseases
December 2, 2015
- MHLW Study Group to Survey Unvaccinated Teens to Resolve HPV Issues
December 1, 2015
- PAFSC’s 2nd Committee Backs Lung Cancer Indication for Opdivo
December 1, 2015
- Development of Orphan Drugs Will Require Global Perspective: MHLW Official
December 1, 2015
- PAFSC 1st Committee Gives Nod to Japan’s First PCSK9 Inhibitor
November 30, 2015
- Evaluation of Efficacy Was Challenging in Sakigake Pick, Designating All Qualified Drugs Desirable: MHLW Official
November 27, 2015
- New Dosage Form of Ciproxan, Other Products with Minor Changes to Join NHI Price List on Nov. 28
November 27, 2015
- MHLW Allows Shipment of Kaketsuken DTP-IPV Vaccine
November 27, 2015
- Drug Pricing Debate to Culminate in December; Abraxane, Zosyn Major Candidates for Market Expansion Re-Pricing
November 26, 2015
- 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
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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…
