REGULATORY

• Panel OKs PI Study for Temcell Use in Refractory Skin Ulcer
  June 24, 2021

• PMDA COVID-19 Vaccine Consultation Draws 129 Inquiries in 8 Months
  June 24, 2021

• Chuikyo OKs Drug Price Survey Plan for FY2022 Revision
  June 24, 2021

• Drug Pricing Rules to Be Applied to Oncolytic Virus Delytact: Chuikyo
  June 24, 2021

• MHLW Panel Roughly OKs Scheme for Generic Makers to Join Revlimid Risk Management Program
  June 23, 2021

• Orphan Status Granted to Unitalc, TransCon PTH
  June 23, 2021

• Japan OKs 2021 Fiscal Policy Blueprint, Vows Transparency in Drug Pricing
  June 21, 2021

• MHLW to Prioritize Application Reviews for COVID-19 Products, Expecting Rush of Filings
  June 21, 2021

• MHLW Aims to Set Up Evaluation Index, Sakigake System for SaMD by March
  June 18, 2021

• Cymbalta Generics Priced at 33.2% of Originator Tags: June Listing
  June 18, 2021

• 9 Drugs Face Generic Entries, AGx Debuts for 2 Brands: June Listing
  June 17, 2021

• Over 30% of Drug Makers Spot Inappropriate Promotions after Guidelines Enforcement
  June 16, 2021

• Report Systems for Improper Drug Promotion Little-Known among Pharmacists: MHLW Study
  June 16, 2021

• LDP Group Urges Stable Generic Supplies, Submits Proposal to MOF
  June 16, 2021

• Label Revisions Ordered for New Safety Risks of Keytruda, Taltz
  June 16, 2021

• Honebuto Text to Add Line for “Transparency and Predictability” of Drug Pricing System
  June 16, 2021

• MHLW Panel Recommends Lifting Ban on Cannabis-Derived Drugs, Eyes Legal Amendment Next Spring
  June 15, 2021

• ICH Adopts Topic on Use of Real-World Data
  June 15, 2021

• LDP Flags 80% Generic Target for All Prefectures: Honebuto Debate
  June 11, 2021

• No Major Concerns over Safety of Moderna, Pfizer COVID-19 Vaccines: MHLW
  June 11, 2021

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