Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan Health Ministry Panel Gives Blessing to Novartis’ PNH Drug Iptacopan and More
A key health ministry advisory panel gave its thumbs-up to Novartis Pharma’s paroxysmal nocturnal hemoglobinuria (PNH) therapy iptacopan, known as Fabhalta overseas, among other medicines on May 31. Novartis’ product was one of the four new molecular entities (NMEs) that…
To read the full story
Related Article
- Japan Approves Novartis’ Fabhalta, Lilly’s Jaypirca, and Lots More
June 25, 2024
- Tapinarof Cream Hits Main Goal in PIII Eczema Trial in Children: JT/Torii
June 3, 2024
- Novartis’ Fabhalta, Novo’s Awiqli, and More Up for PAFSC Review on May 31
May 20, 2024
- JT Files Tapinarof Cream for Eczema, Psoriasis in Japan
September 19, 2023
- AbbVie Files Skyrizi for Ulcerative Colitis in Japan
September 15, 2023
- Novo Nordisk Files Once-Weekly Basal Insulin in Japan
August 10, 2023
- UCB Submits Anti-Epileptic Drug Brivaracetam in Japan
July 31, 2023
REGULATORY
- Defense Chief Seeks MHLW Help Securing Drugs for SDF
September 9, 2026
- PMDA Generic GMP Inspections a Real-World Test to Stem Startup Risks: Official
September 8, 2026
- CEA Review Finds Past Decisions Sound, Sees Room for More Transparency
September 8, 2026
- MHLW Adds Pomalyst Generics to RevMate Safety Program
September 8, 2026
- Japan Extends Shelf Life of Stockpiled Xofluza to 9 Years
September 8, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…