REGULATORY

• Japan’s 1st Hemophilia B Gene Therapy Up for Panel Review on Feb. 19
  February 6, 2025

• PMD Act Set for Amendments Covering Issues Unaddressed over Past Decade: MHLW Official
  February 4, 2025

• Council OKs Public Knowledge Application for CellCept Label Expansion
  February 3, 2025

• LDP OKs Govt’s 5-Year Healthcare Strategy with “Expanding Ecosystems” as Main Pillar
  February 3, 2025

• Lixiana Now Set for Label Expansion; 11 Drugs to Get Orphan Tags
  February 3, 2025

• CSL’s HAE Drug, Tecentriq Sarcoma Use Clear Panel Review; February Approval Expected
  January 31, 2025

• MHLW to Take Balanced Approach in Dealing with Off-Year Revisions: Minister
  January 31, 2025

• MHLW Orders Label Revisions for Lixiana, Keytruda, and More Drugs
  January 30, 2025

• Pfizer’s Litfulo Braced for Price Cut after Cost-Effectiveness Assessment
  January 30, 2025

• MHLW Panel Finalizes NIP Inclusion of Shingles Jabs, OKs New Basic Immunization Plan
  January 30, 2025

• FPMAJ Reports Detailed Results of Blanket Self-Inspections for Generic Firms
  January 29, 2025

• Celltrion Is Developer of Japan’s Third Stelara Biosimilar in the Wings
  January 29, 2025

• MHLW Donates Mpox Vaccine to Congo
  January 28, 2025

• LDP-OK’ed Bill for PMD Act Amendment Specifies Launch of Innovative Drug Fund
  January 28, 2025

• Opposition Party Member Calls for Chuikyo Reform
  January 27, 2025

• Drug Discovery Fund Not Mentioned in Ruling Party Document; All Eyes on Bill’s Review on Jan. 27
  January 24, 2025

• MHLW Eyes 2 Biz Models as It Pushes Generic Industry Shakeup: Minister
  January 23, 2025

• Draft Bill to Amend PMD Act Up for LDP Review on Jan. 27
  January 23, 2025

• How’s Drug Discovery Fund Different from AMED? LDP Member Says It’s Too Early to Submit Legislation
  January 22, 2025

• Astellas’ Xtandi on 2nd Drug List Up for IRA Price Negotiations
  January 21, 2025

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