The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…
REGULATORY
MHLW Orders Label Revisions for Takecab, Clozapine and More
The Ministry of Health, Labor and Welfare (MHLW) on March 19 ordered label revisions related to adverse reactions for a batch of drugs including Takeda Pharmaceutical’s acid reducer Takecab (vonoprazan). In a notification issued on the day, the MHLW urged…
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