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...

The UK has become the first country in the world to introduce a dedicated legal framework for the point of care (‘PoC’) and modular...

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

As part of its pharmaceutical law reform, the EU legislator has proposed a modernised framework for combination products – products that...

This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...

This article is part of a series covering updates to the proposed European Union (EU) pharmaceutical legislation reform, known as the...

Introduction On March 11, 2025, the European Commission introduced the Critical Medicines Act (CMA), a legislative proposal that...

In 2023, the European Commission proposed a comprehensive update of the key EU pharmaceutical legislation (the "Pharma Package") to...

On 4 June 2025, the Council of the European Union adopted its mandate for negotiations with the European Parliament on two European...

On 12 December 2024, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024  were laid before Parliament. These were...

Summary In the recent case of Salts Healthcare Ltd v Pelican Healthcare Ltd [2025] EWHC 497 (Pat), the Patents Court assessed the...

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