REGULATORY

• Sovaldi Has High Unmet Medical Need for Genotype 3 Hep C: MHLW Panel
  August 5, 2016

• Merck Serono Scolded over Delays in Erbitux ADR Reporting
  August 4, 2016

• Kipres/Singulair to Face Generic Onslaught in Dec.; Competition to Hit Tracleer, Too
  August 4, 2016

• Health Minister Shiozaki Retains Post in Cabinet Reshuffle
  August 4, 2016

• MHLW Issues Alert on Teratogenic Risk of CellCept, Generic Versions: Safety Bulletin
  August 3, 2016

• MHLW to Gauge Possible Deregulation of Plasma Export Restriction towards FY2018: Blood Division Chief
  August 3, 2016

• MHLW Study Underway to Delineate Scope of “Essential Drugs”: Official
  August 2, 2016

• Japan Should Reward Innovative Startups through Drug Prices: Report
  August 2, 2016

• MHLW Releases Interim Report for Full-Fledged Rollout of MID-NET
  August 1, 2016

• Compassionate Use Scheme Applied to Pfizer’s Crizotinib
  August 1, 2016

• MHLW Alerts on αβ T-Cell Therapy after Opdivo
  July 29, 2016

• MHLW Official Positive about Seeking Budgets to Boost PMDA Reviewers
  July 29, 2016

• Pricy Meds Issue Takes a Step Forward with 2-Faceted Proposal
  July 29, 2016

• Chuikyo OKs Plan to Compile “Optimal Use Guidelines,” Beginning with Opdivo, Repatha
  July 28, 2016

• Chuikyo to Discuss Out-of-Cycle Re-Pricing for Opdivo, but JMA Turns Wary
  July 28, 2016

• MHLW to Work with PMDA from an Early Stage to Build Clinical Innovation Network: Division Head
  July 28, 2016

• MHLW to Canvass Drug Makers’ Opinions on Real-World Roles of “3 Key Officers”: Pharma Safety Head
  July 27, 2016

• Expert Taskforce Roughly OKs Report on Genomic Medicine
  July 26, 2016

• ICH Clinical Trial Guidelines Allow Flexibility on Number of Japanese Subjects Needed: PMDA Official
  July 26, 2016

• Revised GCP Ordinances Open Ways for Compassionate Use of Medical Devices, Regenerative Medicines
  July 25, 2016

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