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New EU Filings

 
• By Neena Brizmohun

Danicopan, from AstraZeneca, for the treatment of extravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

This is a regularly updated searchable list of products that have been filed with the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) under the EU's centralized authorization procedure. The information is based on the EMA's monthly updated list of medicines under review at the agency, CHMP monthly meeting agendas, company press releases, and original research by the Pink Sheet. 

The EMA's latest monthly filings list, which comprised data extracted on 10 April, included marketing authorization applications (MAAs) for eight new products. (Also see "New EU Filings Include...

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

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 Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.