2/21/2025 10:24:24 AM EPO Board of Appeal Decides Pig/Human Chimera Patent Offends Human Dignity By Quinn Liang Mario Subramaniam The EPO Board of Appeal (“BoA”) recently rejected a patent application relating to pig-human chimeras, concluding that the invention was...
1/13/2025 11:15:48 AM EMA and HMA Update Guidance on Commercially Confidential Information in Marketing Authorisation Applications By Benedicte Mourisse Marc Martens The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...
11/13/2024 1:39:46 PM M&A in Life Sciences By James Baillieu Companies in the life sciences sector and its sub-sectors, including pharmaceuticals, medical devices, diagnostics and services, are...
10/18/2024 10:26:12 AM 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....
9/5/2024 1:59:03 PM What do the Political Guidelines for the Next European Commission bring to the life sciences & healthcare industry? By Hester Borgers Ana-Maria Barbu-Nyström On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...
7/30/2024 2:33:34 PM 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...
7/30/2024 11:47:36 AM New Draft Cybersecurity Act in the Netherlands: What you need to know By Wilfred Steenbruggen Puck van den Bosch In May 2024, the Dutch government published the draft bill for the new Cybersecurity Act (Cyberbeveiligingswet – “CSA”) for consultation...
6/18/2024 10:09:00 AM EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Combating Antimicrobial Resistance By Sarah Faircliffe Caroline Arrighi-Savoie Johanna Harelimana Nour Saab +1 more... Show less On April 10, 2024, the European Parliament voted to adopt a revised version of the European Commission’s proposed reforms to...
6/18/2024 10:05:00 AM CJEU AG opinion: pharmaceutical company has EU VAT refund rights following ex lege payments to state health insurance body By Andy van Esdonk On June 6, 2024, the Advocate General (AG) at the Court of Justice of the European Union (CJEU) delivered an opinion in case C-248/23...
1/18/2024 4:51:00 PM 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...
5/4/2023 5:34:00 PM What the replication crisis means for AI and drug discovery By Phillipus Putter Back in May 2016, the scientific publication Nature surveyed over 1,500 researchers to find out how reproducible their work was. This...
4/24/2023 5:38:00 PM An international overview of the regulatory legislation concerning telemedicine By Katrina Dang Johanna Harelimana Emma Stok Christian Lindenthal, LL.M. Hester Borgers Enrique Rivas Pieter Erasmus Patrick Brown +5 more... Show less Telemedicine has been available to healthcare providers for several years. However, it was not until quite recently that the field of...
12/12/2022 6:43:00 PM The Legal 500: Pharmaceutical Advertising Comparative Guide 2022 By Sally Shorthose Alexandre Vuchot Johanna Harelimana Christian Lindenthal, LL.M. +1 more... Show less The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The aim of this guide is to provide its...
10/25/2022 5:47:00 PM Blood, cells and tissues: regulatory change is coming By Phillipus Putter Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”) in Europe was reshaped by the introduction of the...
7/18/2022 5:49:00 PM Final(ly) Rules of Procedure of the UPC By Christopher de Mauny Domien Op de Beeck Apart from the Unified Patent Court Agreement and a large body of further treaties, regulations, directives and laws governing the...
6/1/2022 5:51:00 PM To opt-out or not? The UPC will change the rules of the game in the European patent field possibly as soon as next fall By Henri Kaikkonen Mikko Nurmisto Early this year it became clear that the long-pending reform of the European patent system is finally coming to fruition. With the...