REGULATORY

• Repatha Gets Price Raise as It Wins Post-Launch Premium for CV Risk Reduction
  March 5, 2018

• 314 APIs Eligible for Price Maintenance Premium in FY2018, Down from 416
  March 5, 2018

• Opdivo Faces 23.8% Price Cut as Slew of Reduction Rules Apply; Nexium Down 16.1% on Huge Seller Slash
  March 5, 2018

• MHLW Unveils New List Prices, Post-Launch Foreign Price Adjustment Applied Only to Opdivo
  March 5, 2018

• MHLW Panel Backs Nobelpharma’s Sirolimus Gel, Azilect, Januvia-Suglat Combo and More
  March 2, 2018

• Enforcement Regulations of Clinical Research Law Promulgated
  March 2, 2018

• Junior LDP Lawmakers Question Drug Pricing: Fiscal Structure Panel
  March 1, 2018

• MHLW Still Pondering Steps to Ensure Proper Sales Activities by Drug Reps
  February 28, 2018

• MHLW Weighs Amendment to PMD Law as It Looks Beyond 2025: Bureau Chief
  February 28, 2018

• Japan Approves 23 NMEs in 2017, Lowest in Past 5 Years
  February 28, 2018

• PMDA to Take Applications for Using MID-NET Starting April 1
  February 27, 2018

• Clinical Research Law to Take Effect on April 1
  February 26, 2018

• Shionogi’s Single-Dose Flu Med Gets Accelerated OK
  February 26, 2018

• Darzalex, Somatuline Grab Orphan Status for New Indications
  February 23, 2018

• PMDA Announces Procedures for Using MID-NET
  February 21, 2018

• Turning Point for Blood Products? Discussions on Basic Policy on Blood Law Moving Ahead
  February 20, 2018

• Chugai Hemophilia Drug, Novel Zoster Vaccine Set for Approval Review on March 2
  February 19, 2018

• Nobelpharma’s Sakigake-Designated Sirolimus Gel Up for MHLW Panel Review on March 1
  February 19, 2018

• Harvoni Approved for Genotype 2 Hep C, Zytiga for Earlier Line
  February 19, 2018

• PhRMA Wants Japan Put on “Priority Watch List” in USTR’s Trade Barrier Report
  February 16, 2018

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