04 Nov, 2024 Licensing and Collaborations in Life Sciences By James Baillieu Sally Shorthose There is a huge cost of bringing a pharmaceutical product to market, with estimates ranging from US$1-2 billion to take a product from...
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....
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...
17 Sep, 2024 The DNA of Life Sciences Deals By James Baillieu Maria John The life sciences sector, comprising of sub-sectors like pharmaceuticals, medical devices, diagnostics and services, aims to cure disease...
27 Aug, 2024 Clinical Trial Update in Ireland: New model Clinical Trial Agreement for Tripartite Clinical Trials in Ireland By Kelly Mackey Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...
30 Jul, 2024 New UK government’s plans for life sciences: the people and policies explained By Sally Shorthose Heidi Hurdle Charlotte Getz The UK life sciences industry takes centre-stage in two of the new Labour government’s “Five Missions For National Renewal”: economic...
18 Jan, 2024 SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – Preparation Authorisation under the SoHO Proposal By Marc Martens Lora Arifagic The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide...
18 Dec, 2023 The Legal 500: Pharmaceutical Advertising Country Comparative Guide 2023 By Sally Shorthose Pieter Erasmus The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The aim of this guide is to provide its...
14 Sep, 2023 EMA’s envisaged risk-based and human-centric approach to regulate AI By Hester Borgers Christian Lindenthal, LL.M. Dr. Nils Lölfing Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
10 Aug, 2023 AI and the life sciences, navigating the complex legal landscape By Hester Borgers Christian Lindenthal, LL.M. Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
09 Aug, 2023 EU Commission’s proposed changes to marketing authorisation procedures By Sophie Vo Sally Shorthose This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
07 Aug, 2023 Reforming the European pharmaceutical legislation: Shortages of medicinal products By Lora Arifagic Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
26 Jul, 2023 What does the European Commission’s proposed reform of EU pharmaceutical legislation mean for Paediatric medicines? By Phillipus Putter Sarah Faircliffe This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...
12 Jul, 2023 Code of practice introduced for holding cultivated meat tastings By Emma Stok Sander Wagemakers Hester Borgers Nicolas Carbonnelle +1 more... Show less Particularly in the Netherlands, developments in the field of cultivated meat have succeeded each other rapidly over the past years....