Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
COMMENTARY
Will Zolgensma Delay Spur Revision of Sakigake Designation System?
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…
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