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REGULATORY NEWS IN BRIEF

October 5, 2009
NovoRapid 50 Mix ApprovedNovo Nordisk Pharma obtained on September 18 marketing approval for the biphasic insulin analogue NovoRapid 50 Mix FlexPen and its cartridge formulation NovoRapid 50 Mix Penfill (recombinant insulin aspart).NovoRapid 50 Mix is a 5:5 combination of ultra…

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

By Tatsuya Otsuka

Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…

By Philip Carrigan

We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

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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…