BUSINESS

Amgen Eyes Simultaneous Filing in Japan, US, EU for 3 Key Drivers, including Next-Gen BiTE Drug: R&D Chief

By Takashi Ebisawa April 11, 2023
Amgen is aiming for simultaneous regulatory filings in the US, Japan, and Europe for three mid- to late-stage assets that would drive the company’s growth over the coming years, including its next-generation bispecific T-cell engager (BiTE) antibody targeting solid tumors.…

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BUSINESS

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Shinya Sato

Japan is opening a new chapter in sleep medicine. The recent decision to allow medical institutions to advertise “sleep disorders”…

By Philip Carrigan

Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…

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…