28 Oct, 2024 EU Pharmaceutical Reform: Update on the proposed changes to paediatric medicinal product legislation By Phillipus Putter This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
18 Oct, 2024 Venture Capital and Venture Debt in Life Sciences By James Baillieu In recent decades, venture capital (VC) has played an increasingly important role in the high-risk and high-reward life sciences sector....
14 Oct, 2024 Fight against medicine shortages: the French Medicines Agency (ANSM) imposes fines totalling €8 million By Caroline Arrighi-Savoie Johanna Harelimana Nahla Ghouali On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...
09 Oct, 2024 Case C-237/22 of the CJEU – Clarification of the concepts of “Significant Benefit” and “Clinical Superiority” By Marc Martens Benedicte Mourisse The CJEU brings clarity, on the concepts of “Significant Benefit” and “Clinical Superiority” with respect to Orphan Medicinal Products...
02 Oct, 2024 Navigating the Complex Landscape of Merger Control and Foreign Direct Investment in Life Sciences in the EU and UK By James Baillieu Dr Saskia King In the rapidly evolving world of life sciences, merger control and foreign direct investment (“FDI”) regimes have emerged as key...