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
Nesp Biosame to Join NHI Price List, Launch Due by September; Symbicort Generics, Teribone AG Skip Listing
The Ministry of Health, Labor and Welfare (MHLW) will add a slew of generics to the NHI price list on June 14, including the so-called “biosame” version of the Nesp (darbepoetin alfa) renal anemia drug, according to the official gazette…
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