TOP STORIES

• REGULATORY Lilly’s Tirzepatide in Line for Approval as Early as September as Japan’s 1st GIP/GLP-1 Agent
  August 26, 2022

• REGULATORY Japan Approves Label Expansions for Lynparza, Ultomiris, Keytruda, Tagrisso, and More
  August 25, 2022

• BUSINESS BMS Wants to Jolt Cancer Care Landscape with Broader I/O Combo Options, Pursuing LAG-3 Inhibitor in Japan Too
  August 24, 2022

• REGULATORY MHLW to Boost Orphan Program to Fuel New Drug Development: FY2023 Budget Request
  August 23, 2022

• REGULATORY After Repeated Scandals, PMDA Sets Up New Division to Provide GMP Inspection Know-How to Prefectures
  August 22, 2022

• REGULATORY Operational Issues of Emergency Approval Scheme Will Be Addressed If Needed: Pharma Bureau Chief
  August 19, 2022

• BUSINESS Lagevrio Joins NHI Price List, Normal Distribution to Start Once Ready
  August 19, 2022

• BUSINESS Incyte Japan Urges Reward for Innovation in Rare Diseases as Pemazyre Filed for Ultra Orphan Cancer
  August 18, 2022

• ORGANIZATION JaDHA Hopes to Issue First Policy Proposal to Solve Digital Health Challenges by Year-End: Chairman
  August 17, 2022

• REGULATORY AZ’s Asthma Drug Tezepelumab Up for MHLW Panel Review on August 29
  August 17, 2022

• REGULATORY Generic Makers Flock to Samsca’s Heart Failure Market after Patent Invalidated; Gx Listing Expected in December
  August 16, 2022

• REGULATORY Authorized Generics Approved for Nexium, Samsca, Lipitor, Careram
  August 16, 2022

• REGULATORY First Generics for 5 APIs Approved towards December Listing, with 8 Firms for Nexium
  August 16, 2022

• REGULATORY Lilly’s GIP/GLP-1 Receptor Agonist Up for PAFSC Review on August 25
  August 15, 2022

• REGULATORY 26 Suspected Violations in Detailing Activities Reported in FY2021: MHLW
  August 12, 2022

• BUSINESS Sumitomo Pharma to Rev Up R&D for Regenerative Medicine, CNS towards Later 2030s
  August 12, 2022

• REGULATORY Chuikyo OKs Lagevrio, Voxzogo, Enjaymo, and More for August Listing, BioMarin Med with Biggest Peak Sales Outlook
  August 10, 2022

• REGULATORY Rybelsus Faces 2.5-2.6% Price Cut in November under CEA Scheme; No Change for Cabometyx
  August 10, 2022

• BUSINESS Sumitomo Drops 100 Billion Yen Diabetes Sales Goal as Trulicity Collab Ends
  August 10, 2022

• BUSINESS Yen’s Fall Reaps 10 Billion Yen-Plus Gain on Sales for 5 Japan Makers, Takeda Gets 8.8 Billion Yen: April-June
  August 9, 2022

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