BUSINESS

Takeda’s Narcolepsy Drug Snags FDA’s Breakthrough Therapy Tag

July 30, 2021
Takeda Pharmaceutical said on July 29 that the US FDA has granted Breakthrough Therapy designation to its oral orexin agonist TAK-994, which is in PII development for the treatment of narcolepsy type 1. The designation was supported by early phase…

To read the full story

Related Article

BUSINESS

By Ken Yoshino

Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…

By Takashi Ebisawa

Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…

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…

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…