REGULATORY

• MHLW Panel to Discuss Opdivo for Hodgkin’s Lymphoma on Oct. 27
  October 17, 2016

• Huge Costs, Amount of Application Data Required Will Be Major Challenges in Development of Biosimilars: Open Forum
  October 14, 2016

• Health Minister to “Positively Consider” Setting Biosimilars Use Target
  October 14, 2016

• AMED to Open Office in Washington D.C.
  October 13, 2016

• 30% of Rejected Requests for Health Damage Compensation Due to Improper Drug Use: MHLW
  October 12, 2016

• MHLW Study Group to Revise 75 Manuals on Serious ADRs in 19 Fields Over 5-Year Period
  October 12, 2016

• MHLW to Consider Additional Penalties for Kaketsuken after Reviewing Its Report: Minister Shiozaki
  October 11, 2016

• Current Information Disclosure for DPO Discussions Appropriate: Shiozaki
  October 7, 2016

• Univ. of Tokyo and Kyoto Univ. Selected to Participate in Project to Train Biostatisticians: AMED
  October 7, 2016

• Make “High-Level Investment” Credits Permanent under R&D Tax Break: Industry
  October 6, 2016

• Chuikyo Green-Lights Basic Plans on “Optimal Use Guidelines,” Notification Letters
  October 6, 2016

• Chuikyo OKs Application of Huge-Seller Re-Pricing to Opdivo; Payers Loath to Use Ono Sales Outlook for Calculation
  October 6, 2016

• 2nd Round of Sakigake Invitations Gets Underway
  October 5, 2016

• MOF Pushes for Overhaul of Drug Pricing System, Says It Can’t Address Pricy Meds
  October 5, 2016

• Kaketsuken Faces Another Penalty over Encephalitis Vaccine Manufacturing
  October 5, 2016

• MHLW, PMDA Set Up “Preparatory Offices” to Plan Future Support System for Startups
  October 5, 2016

• MHLW Orders Nagoya Univ. to Probe Corrections Made to Diovan Paper
  October 4, 2016

• Bayer Launches Recall of Hemophilia Med Kogenate over Potency Loss
  October 4, 2016

• Drug Discovery Support Network to Announce Withdrawn Research Themes; Companies Will Be Able to Use This as “Negative Data”
  October 4, 2016

• MHLW Says It Will Compile “Optimal Use Guidelines” for Keytruda Too
  October 3, 2016

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