REGULATORY

• Opdivo Gets MHLW Panel Nod for Hodgkin’s Lymphoma
  November 14, 2016

• MHLW Panel to Discuss NSCLC Indication for Keytruda on Nov. 24
  November 14, 2016

• LDP Study Group on Biologics to Hold 1st Meeting on Nov. 24; Aims to Halt the Rush to Promote Biosimilars
  November 11, 2016

• Chuikyo Members Chide Unexplained Withdrawal of Taltz’s Listing Request
  November 10, 2016

• MHLW Won’t Require Use of Other Psoriasis Drugs before Taltz
  November 10, 2016

• MHLW Plans 50% Price Cut for Opdivo
  November 10, 2016

• Chuikyo OKs Taltz, Micatrio for Listing on Nov. 18; Keytruda Takes Pass This Time
  November 9, 2016

• LDP Lawmakers Discuss Re-Pricing of Opdivo; Some Say Application of Huge Seller Rule Reasonable
  November 9, 2016

• Shiozaki Lauds BIKEN-Mitsubishi Vaccine JV
  November 8, 2016

• PMDA Fastest in Granting New Drug Approvals
  November 4, 2016

• PMDA Mulls Fee Raise for Drug, Device Reviews
  November 4, 2016

• Medical Corporation in Tokyo Ordered to Temporarily Suspend Regenerative Medicine Service: MHLW
  November 4, 2016

• MHLW Struggling to Set Date for Chuikyo Subcommittee Discussions on Opdivo
  November 2, 2016

• MHLW Panel Backs Ono’s Hyperparathyroidism Drug Etelcalcetide
  November 1, 2016

• PMDA Had 71 Individual Interviews in Regulatory Strategy Consultation Services in April-September 2016
  November 1, 2016

• Inisync, 4 Other DPP-4 Inhibitors Under PMDA Risk Review
  October 31, 2016

• Postponed PAFSC 2nd Committee Meeting Set for November 11
  October 31, 2016

• MID-NET Working Group Discusses Access Fee Calculations
  October 28, 2016

• Long-Listed Drug Use by Welfare Recipients Should Require Copay: MOF
  October 28, 2016

• Panel Negative about Singling Out OTC-Switched Rx for Health Coverage Talks, Calls for Broader Discussions
  October 27, 2016

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