EMA's First PUMA Recommendation Is One Small Step For Kids
This article was originally published in The Pink Sheet Daily
Years in the making, the Buccolam recommendation is glad news, but also illustrates that the incentive the Paediatric Use Marketing Authorisation program offers to manufacturers is likely not enough.
You may also be interested in...
Europe’s top scientific advisory panel also gave positive recommendations to BioMarin’s orphan drug Vimizim for use in mucopolysaccharidosis type IVA, and the compassionate use of a fixed combination of two of Gilead Science’s antivirals in hepatitis C, sofosbuvir and ledipasvir, after its meeting Feb. 17-20.
The European Medicines Agency is focusing on transparency and pharmacovigilance over the next year, while the pharmaceutical industry is gearing up for a fight against austerity measures.
FDA is citing patient access as the reason behind its unusual decision to insert itself in the middle of a pricing debate involving KV Pharmaceuticals’ pre-term delivery drug Makena.