On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...more
The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more
Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. ...more
The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items which companies should be...more
The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice...more