BioTalk

  1. Introduction On 12 December 2025, the European Data Protection Board (EDPB) hosted a focused stakeholder event to gather input for...

Our foreign clients often ask us about the statute of limitations for personal injury under French law. While the question may appear...

Understanding the impact of the European Accessibility Act on Medical Devices The European Accessibility Act (Directive (EU) 2019/882)...

Recent German court decisions have fundamentally shifted the risk landscape for generic and biosimilar companies facing second medical...

The EU regulatory landscape for medical devices making use of artificial intelligence (MDAI) has become significantly more complex with...

As digital health applications become increasingly sophisticated and telemedicine (the distribution of health-related information and...

On 5 March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union....

The EPO Board of Appeal (“BoA”) recently rejected a patent application relating to pig-human chimeras, concluding that the invention was...

On 11 December 2024, the MHRA published an updated roadmap for the future of the regulatory framework for medical devices in the UK,...

* This article was co-authored with Olivia Zhao from Bird & Bird Lawjay Shanghai association team.  On 3 January 2025, the General Office...

On 9 September 2024 the European Medicines Agency (“EMA”) issued its final reflection paper on the use of AI in the medicinal product...

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...

Companies in the life sciences sector and its sub-sectors, including pharmaceuticals, medical devices, diagnostics and services, are...

In recent decades, venture capital (VC) has played an increasingly important role in the high-risk and high-reward life sciences sector....

On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...

The UK life sciences industry takes centre-stage in two of the new Labour government’s “Five Missions For National Renewal”: economic...