Europe

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include Hympavzi, Pfizer's treatment for adults and adolescents with severe hemophilia A or B without inhibitors.

The new court ruling could enhance the appeal of the Unified Patent Court for enforcing European patents.

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

The European Medicines Agency is encouraging companies to submit the type I variations they want to make to their marketing authorizations by the end of this month.

The health technology assessment institute said its “unique insights” could help companies effectively prepare for their appraisals, potentially streamlining their path through the process, and helping to get innovative technologies to patients faster.

Dual filings for Formycon’s aflibercept biosimilar have delivered results, with the Eylea rival endorsed under two names by the EMA’s CHMP.

Samsung Bioepis may be only the second company to obtain an EMA positive opinion for a denosumab biosimilar, but plenty more rivals are on the way with filings of their own.

The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

After an initial rejection, the European Medicines Agency now says that Eisai/Biogen’s Alzheimer’s disease drug should be approved, albeit with a recommendation for initial generic screening and ongoing safety scans.