REGULATORY

• Invoice Price Rates Decline Only for Long-listed Drugs at 3 Companies: MHLW Survey
  June 4, 2018

• “Preclinical Registry” Will Accelerate Drug Discovery in Field of Dementia: AMED President
  June 4, 2018

• AMED to Increase Transparency in Funding by Opening Up Research Database to Public
  June 1, 2018

• Ex-Minister Shiozaki Holds Talks with PhRMA, EFPIA
  June 1, 2018

• MHLW to End Manufacturing Record Inspection for Kaketsuken’s Plasma Fraction Products
  June 1, 2018

• MHLW Positive on Enshrining Conditional Approval, Sakigake Schemes into Law: Official
  May 31, 2018

• Japan’s First Biosimilars for Enbrel, Herceptin Added to NHI Price List
  May 30, 2018

• Honebuto Policy Won’t Include Numerical Target for Social Security Costs
  May 29, 2018

• Takeda’s Entyvio Up for MHLW Panel Review on June 8
  May 28, 2018

• MHLW Grants Orphan Status to Vyndaqel, Burosumab
  May 28, 2018

• MHLW OKs Add’l Indications for Xeljanz, Botox, Nucala
  May 28, 2018

• MOF Pitching 2-Step Drug Price Tweaks in 2019 Tax Hike Year
  May 25, 2018

• MHLW Flu Panel Approves Plan to Switch to H7N9 Strain for Pre-Pandemic Flu Vaccine
  May 25, 2018

• Chuikyo Approves Insurance Reimbursement for 3 Medical Devices, with Listing Scheduled for June
  May 25, 2018

• Chuikyo Tightens Physician Fee Rules for Self-Injections, Biosimilars Up for Individual Review
  May 25, 2018

• Lynparza’s Breast Cancer Use, Chugai’s Obinutuzumab Clear MHLW Panel
  May 24, 2018

• PMDA, FDA Team Up to Help Developing Countries to Facilitate Pediatric Drug Development
  May 24, 2018

• Revisit Automatic Coverage for New Drugs, Discuss Mandatory CEA: MOF Panel Proposal
  May 24, 2018

• No Specific Social Security Cost Target Discussed at CEFP, All Eyes on How to Handle FY2019-FY2021 Elderly Trough
  May 22, 2018

• MHLW Presents Schedule for Discussions on Inclusion of 6 Vaccines in Public Vaccination Programs
  May 21, 2018

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