The New AIFA Algorithm For Assessing ‘Innovativeness’ Of New Products In Italy: So What?

In April 2017, AIFA (Agenzia Italiana del Farmaco, Italian Medicines Agency) released a new algorithm to assess and evaluate the level of innovativeness of new drugs aimed to get reimbursement by the SSN (Sistema Sanitario Nazionale, National Health System) through the EUR 1 billion fund made available by the Italian…

Strategic Patient Advocacy vs. Evidence Package: The “Rare” Challenge for Orphan Drug Manufacturers

On September 19, 2016, the USA FDA granted accelerated approval to $SRPT (SAREPTA THERAPEUTICS) lead product, EXONDYS 51™(eteplirsen), the first targeted treatment for (DMD), a devastating rare disease. What makes the case unusual is that in approving EXONDYS 51™, the FDA went against the recommendation of its Advisory Committee, a…

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