Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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US FDA Issues Warning Letter Over GMP Violations by Daiichi Sankyo Subsidiary
The US Food and Drug Administration (FDA) has issued a warning letter to Luitpold Pharmaceuticals Inc., a US subsidiary of Daiichi Sankyo, regarding what it calls “significant” GMP violations at a New York manufacturing facility. The letter was made public…
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- MHLW Lifts Olanzapine Diabetes Contraindication for Antiemetic Use
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- Japan Approves Takeda’s Orzeyful, Insmed’s Brinsupri and More Drugs
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More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…