Dengue Vaccine Qdenga & Nine Drugs Win EMA Thumbs Up

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.