Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
COMMENTARY
Will Zolgensma Delay Spur Revision of Sakigake Designation System?
The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…
To read the full story
Related Article
- Yescarta Sails through PAFSC Review; Panel Roughly OKs Novartis’ Corrective Measures after Zolgensma Delay
December 4, 2020
- Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
September 8, 2020
- Japan Regulators Upped Zolgensma Price after Novartis Complaints: Chuikyo Paper
May 13, 2020
- Zolgensma to Get Japan’s Highest List Price 167 Million Yen, but Peak Sales Put at Just 4 Billion Yen
May 12, 2020
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
COMMENTARY
- A “Core Industry” in Name Only? Drug Pricing Reform Leaves a Sour Taste
March 24, 2026
- Beyond Elevidys: Next-Generation DMD Therapies Advance through Multiple Approaches
March 11, 2026
- Elevidys Opens New Era for DMD Treatments Targeting the Underlying Cause
March 10, 2026
- ICH Weighs Need for Biosimilar Efficacy Trials as Regulators Move Away from Routine Use
March 9, 2026
- G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands
February 25, 2026
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
Japan’s FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…
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…