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
Pharma Industry Might Accept Comparator PMP Deduction If No Eligible Use Added in 6 Years
The pharmaceutical industry strongly opposes a simple expansion of the current rule to deduct the price maintenance premium (PMP) from PMP-granted comparator drugs in the pricing of new medicines deemed PMP-ineligible, but might accept such deduction if no PMP-eligible indications…
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