REGULATORY

• MHLW OKs First Generics for Tracleer, 6 Other APIs towards December Listing
  August 16, 2016

• MHLW Study Group to Look at Measures to Popularize Biosimilars, Increase Efficiency in Development and Manufacturing
  August 12, 2016

• Startup Promotion Guide to Support Major Companies as well: MHLW Official
  August 10, 2016

• JMA, MHLW Say Possible Opdivo Re-Pricing Is Emergency Step, Won’t Make It Slippery Slope to Annual Revisions
  August 9, 2016

• Key Govt Panel Sets Sights on Pricy Meds
  August 9, 2016

• Japanese Society of Nephrology Wins AMED Funding for “Surrogate Endpoint” Guidelines
  August 8, 2016

• MHLW Panel OKs Opdivo for RCC, ASKA’s Hepatic Encephalopathy Drug
  August 8, 2016

• MHLW Unveils Draft Fast-Track Scheme for Drug-Resistant Infection Treatments
  August 5, 2016

• MHLW Advisory Panel Backs Nesina-Metformin Combo
  August 5, 2016

• 4 Bcr-Abl TKIs Ordered to Add Risk of HBV Reactivation in Labels: MHLW
  August 5, 2016

• 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

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