COMMENTARY

• Sakigake Designation System to Link Regulatory and Drug Pricing Systems; Could Result in Tougher Scrutiny for Designated Products
  November 6, 2015

• Data from Humanitarian Trials to Be Used in Product Reviews; Effective Use of Safety-Related Information Will Be Key
  October 13, 2015

• Japan, US, EU Regulators Trod Different Paths to Iressa Approval; Japan’s Capabilities to Be Tested with Sakigake System
  September 24, 2015

• How Will Industry Counter Proposed Re-Pricing of “Huge Seller” Drugs?
  August 18, 2015

• Leaner Sales Forces? Lower Profits? Drug Makers Face Tough Decision in 80% Generic Era
  August 14, 2015

• PMDA Poised to Tap Big Data to Refine Reviews, Safety Steps; Dedicated Center Eyed in 2018
  August 12, 2015

• Wholesalers Face Pressing Need to Retool Biz Strategy as Generics Gain Ground
  July 21, 2015

• Viable Third-Party Review System Required for Drug Makers’ Advertisements
  July 7, 2015

• Japan Compassionate Use System a “Stick” for Drug Makers? Incentives to Counter Their Burden Needed
  June 22, 2015

• Generic Makers Baffled by New Govt Target, Quality and Supply Concerns Linger
  June 15, 2015

• Thorny Path Ahead toward Trial Rollout of Cost-Effective Assessment in FY2016; Chuikyo to Begin Discussions on May 27
  May 26, 2015

• 1 Year after Viagra Generic Debut, Freely Priced Generics Seem to Be Bringing Benefits
  May 8, 2015

• Opdivo Offers Hope but Poses Challenges Too, Cautious Approach Needed to Expand Indications
  April 27, 2015

• Will Japanese Drug Makers Become More Discerning in Unearthing Seeds?
  April 17, 2015

• Patient Subsidy System Expanded for Intractable Diseases, What about Incentives for Drug Makers?
  April 7, 2015

• Abe Pledges Biosimilar Promotion, but Doctor Misconception and Lack of Incentives Remain as Challenges
  March 30, 2015

• SGLT-2 Inhibitor Sales Would Plunge If Used Only in Younger, Obese Patients, but Cautious Administration Warranted
  March 17, 2015

• Uncertainty Swirling around Possible Drug Price Cuts for 3 Straight Years
  March 16, 2015

• Drug Repositioning May Promise Greater Chance of Success, but Problems Remain
  March 6, 2015

• As Adjuvant Development Race Heats Up, New Databases Could Turn Japan into Global Vaccine Powerhouse
  February 16, 2015

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