Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
REGULATORY
MHLW Orders Label Revision for Elevidys to Add Acute Hepatic Failure
The Ministry of Health, Labor and Welfare (MHLW) on August 28 ordered a label change for Chugai Pharmaceutical’s Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec), adding acute hepatic failure as a serious adverse reaction following reports of fatal cases…
To read the full story
Related Article
- Elevidys Coverage Debate to Resume after MHLW Gains Broad Understanding on Safety
October 9, 2025
- Chugai to Defer Domestic Supply of Elevidys amid Safety Review
July 25, 2025
- Japan Puts a Hold on Coverage Discussions for Elevidys over Safety Concerns
June 19, 2025
- Chugai Halts Dosing of Non-Ambulatory Patients in DMD Gene Therapy Trial after 2 Deaths Overseas
June 17, 2025
- Chuikyo Agrees to Vet Conditional Scheme for Regenerative Medicine as Elevidys Gets Approval
May 15, 2025
- Chugai’s DMD Gene Therapy Snags Conditional Approval in Japan
May 14, 2025
REGULATORY
- Another LDP Study Group Submits Emergency Proposal Urging Drug Pricing Overhaul
December 5, 2025
- Ishin Urges Takaichi to Revisit OTC-Like Drug Coverage, Softens Savings Target
December 5, 2025
- JPMA Chief Presses LDP Study Group to Lock In On-Patent Prices, Scrap “Spillover” Rule
December 5, 2025
- LDP, Ishin to Continue OTC-Like Drug Talks on “Special Charge” Design
December 5, 2025
- Forxiga, Zytiga Seen Taking Biggest Hit by PMP Returns in FY2026
December 5, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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…