The COVID-19 pandemic is causing major disruptions that impact citizens, patients and businesses, including the activities of pharmaceutical companies.
Big Data for public health in the EU: HMA-EMA’s recommendations
Data data data…
It seems that this new decade will become the decade of data.
eSubmission Portals
Telematics strategy of the different Regulatory Authorities is having an increasing growth.
Today we’re going to talk about the main e-submission portals.
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.
