BUSINESS

Data Acquisition Completed for Anti-HIV Treatment, Submission for Regulatory Approval in US, Europe Planned By Year End: Shionogi

October 5, 2012
Shionogi & Co. announced on October 4 that its US joint venture company had completed its acquisition of clinical trial data that is required to file for regulatory approval for its investigational integrase inhibitor dolutegravir (generic name; Shionogi development number:…

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BUSINESS

By Shunsuke Tani

PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…

By Takashi Ebisawa

Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…

By Koji Shimomura

Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…

Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…

By Takashi Ebisawa

Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…

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

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

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…