AsphaTrainings Program | At Asphalion we preparing a spring full of online trainings in Regulatory Affairs

We are very pleased to announce the launch  of the AsphaTrainings Program. We think it is essential to keep  our Regulatory Affairs community updated and trained during this time. As a response to the postponement of most educational events in the field of Regulatory Affairs due to COVID-19, our aim is to offer high quality RA Content.

Rare Diseases

Atlas Molecular Pharma receives an ODD with Asphalion support

On January 17th, 2018, the European Commission granted Ciclopirox (L2.7.D7) the Orphan Drug Designation (ODD) and few months later, on 17th April 2018, the Food and Drug Administration (FDA) also granted ODD for the product. This is the first time that the agencies issue a positive opinion for this rare disease. Therefore, Ciclopirox represents the only drug with ODD for this genetic condition. Asphalion and Atlas have been working together in this challenging process for ODD application.