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REGULATORY
- MHLW Panel on Blood Programs Approves 950,000-Liter Acquisition Target for Raw Plasma in FY2016
January 22, 2016
- Bill Payer Proposes “Penalties through NHI Prices” for Violations of Pharma Law in Wake of Kaketsuken Scandal: Chuikyo
January 22, 2016
- 4 Listed Drugs plus Similar Products Subject to Cost-Effectiveness Review: Chuikyo
January 21, 2016
- Chuikyo OKs New Drug Pricing Rules for FY2016 Reform; Sakigake-Designated Add’l Indications Also Subject to Premiums
January 21, 2016
- MHLW to Designate 617 Products/134 APIs as “Essential Drugs”: Will Receive Uniform, Stable NHI Prices, Exempt from Z2 Rule
January 21, 2016
- “Huge Seller” Re-Pricing to Hit Sovaldi, 3 Other Brands; Hefty 20 APIs Face Regular Market Expansion Re-Pricing
January 21, 2016
- Need of Placebo-Controlled Studies Will Be Decided on Case-by-Case Basis: PMDA Official
January 20, 2016
- Seriousness of Target Diseases, Efficacy Became Key in Sakigake Designation: MHLW Official
January 20, 2016
- Drug Makers Told to Check Conformity of Manufacturing Process with Approved Methods
January 20, 2016
- PAFSC’s 2nd Committee to Review Novartis’s Melanoma Drugs on Feb. 1
January 20, 2016
- “Huge Seller” Re-Pricing to Hit Sovaldi, Harvoni, Avastin, Plavix
January 20, 2016
- Discussions on Market Price Survey for 2017 Revision Likely to Begin in March, Conclusion Expected in June
January 19, 2016
- Abe Vows to Work All-Out to Supervise Drug Manufacturers after Kaketsuken Oversight
January 19, 2016
- ICH-S9 Guideline to Apply to Non-Clinical Studies for “Serious Malignancies”
January 19, 2016
- New ICH Trial Guidelines to Embrace “Pooled Populations,” but PMDA Unlikely to Accept Zero Japanese
January 18, 2016
- MHLW Taskforce on Vaccines, Blood Products Kicks Off Discussions
January 15, 2016
- Research-Driven Makers Should Find Another Biz Model If They Can’t Innovate: Top Bureaucrat
January 15, 2016
- Fulminant Hepatitis to Be Added to List of Significant Adverse Reactions to Amlodipine Products
January 14, 2016
- AMED, US NIH Ink Memorandum of Cooperation for Orphan Diseases, Cancer
January 13, 2016
- Kaketsuken Ordered Record 110-Day Suspension, Shiozaki Says He Won’t Allow It to Remain As-Is
January 12, 2016
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