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…
REGULATORY
Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
Mitsuaki Kamata, director general of the Pharmaceutical Safety and Environmental Health Bureau, urged Novartis Pharma to seriously reflect on its flaws in the review process for sakigake-designated Zolgensma (onasemnogene abeparvovec) whose approval was delayed. The company’s products should be made…
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