BUSINESS

Arena Submits Response to FDA CRL for Lorcaserin: Eisai

January 5, 2012
Arena Pharmaceuticals, Inc. of the US submitted on December 27, 2011 a response including additional data to a complete response letter (CRL) issued by the US FDA for the company’s obesity treatment lorcaserin, for which approval is pending in the…

To read the full story

BUSINESS

Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…

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’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…