REGULATORY

Gene Therapies from Ferring, Ultragenyx in Line for Orphan Status, Moderna mRNA Drug Too

December 10, 2024
A Japanese health ministry panel on December 9 agreed to grant orphan designation for three regenerative medicine products including Ferring Pharmaceuticals’ bladder cancer gene therapy nadofaragene firadenovec, known as Adstiladrin in the US. The Pharmaceutical Affairs Council’s Committee on Regenerative…

To read the full story

Related Article

REGULATORY

By Philip Carrigan

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…

By Ken Yoshino

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,…

By Ken Yoshino

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…