The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
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REGULATORY
- PMDA to Establish Asian Regulatory Training Center on April 1
March 29, 2016
- Panel Finalizes “No Efficacy” Decision for Lysozyme, Pronase; MHLW Issues Notifications for Ethical, OTC Products
March 28, 2016
- Drug Makers, Distributors Won’t Set Interim Targets for Mandatory Barcode Labeling, but Keep Tabs on Progress
March 25, 2016
- MHLW Officially Sets Out Plan to Draw Up New Pharma Industry Vision
March 24, 2016
- Shiozaki Hints at Delay in MHLW Report on Vaccines and Blood Product Policies
March 24, 2016
- Ethical Hurdles for Placebo-Controlled Studies Could Be Cleared with Certain Designs: PMDA Panel
March 23, 2016
- MHLW Alerts on Risk of Respiratory Depression for Flunitrazepam Injectables, Orders Label Revision
March 23, 2016
- PMDA Chief Kondo Reappointed for 5th Term
March 23, 2016
- Drug Makers Should Ponder Their Role in Community-Based Integrated Care System: MHLW Official
March 22, 2016
- MHLW OKs Cymbalta’s New Pain Indication, Raises Caution on Its Use
March 22, 2016
- New Basic Guidelines for Hepatitis Measures to Push IFN-Free Therapies, Hep B Vaccines
March 18, 2016
- MHLW Official Asks Industry to Discuss Candidates for Essential Medicines
March 18, 2016
- Kamoya Prods Regulatory Science Society to Compile Essential Drug List
March 17, 2016
- Whether to Draw Line between 15 Billion and 100 Billion Yen Sales Thresholds for Re-Pricing Will Hold Key: Kamoya, Nakai
March 17, 2016
- Coefficient for New Generic Pricing “Will Decline Further” if Business Practices Are Not Changed: JGA Official
March 17, 2016
- Opdivo Gets Orphan Status for Hodgkin’s Lymphoma
March 17, 2016
- Nobelpharma CEO Says Sakigake System “Very Helpful”
March 17, 2016
- PMDA Had 43 Advanced Regulatory Advisory Sessions with Startups, Academia in FY2015
March 16, 2016
- Vaccine Panel Wary about Including Synflorix in Public Immunization Program
March 16, 2016
- Oculomucocutaneous Syndrome, Erythema Multiforme Added to ADR List for Halaven
March 16, 2016
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PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
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