REGULATORY

• Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
  October 1, 2024

• Ex-Health Minister Nemoto to Retire from Politics
  October 1, 2024

• Ishiba Elected as New LDP Leader, Hopes Are High for Medical and Pharma Policies
  September 30, 2024

• MHLW Set to Redefine “Vaccines of High Development Priority” in New Plan
  September 27, 2024

• MHLW to Publish Info Necessary for Driving Biosimilar Switches in FY2025
  September 27, 2024

• Kisunla Subject to Prior Pricing Review as It Follows Leqembi’s Footsteps
  September 26, 2024

• Off-Year Debate “Won’t Progress” without Industry’s Behavioral Change: JMA Rep
  September 26, 2024

• MHLW Panel Puts a Hold on Proposed Use of Abortion Pill at Clinics Without Beds
  September 26, 2024

• Japan Approves Lilly’s Kisunla, Eisai’s ALS Med, Gilead’s Trodelvy, and Lots More
  September 25, 2024

• NIBIOHN, Institut Pasteur Link Arms in Drug, Vaccine Research
  September 24, 2024

• More Pregnant Cases Reported for COVID Meds, Panel Urges Greater Caution
  September 24, 2024

• Ultragenyx’s Gene Therapy in Line for Orphan Tag in Japan
  September 24, 2024

• Orphan Status Granted to Sanofi’s Venglustat and More in Japan
  September 24, 2024

• Japan Pulls Sakigake Tags from Olumiant, Xevinapant
  September 24, 2024

• Panelists See Legal Issue over Providers’ Refusal of People Vaccinated with Replicon Shot
  September 20, 2024

• MHLW to Update Decade-Old Generic Roadmap, Add Blueprint for Biosimilars
  September 20, 2024

• Japan Panel OKs 5 COVID Vaccines for NIP Use from October
  September 20, 2024

• Puberulic Acid Determined as Cause of “Beni-Koji” Health Damages
  September 19, 2024

• MHLW Working Group Gets into Details of Proposed Drug Supply Info System
  September 18, 2024

• “Kobe Model” Offers Unique Subsidy to Diagnose Dementia, Test Eligibility for Lecanemab
  September 18, 2024

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