BioTalk

A recent EU directive will have significant consequences for Australian life sciences companies operating in Europe. Directive 2024/2853...

A new European directive is set to significantly impact pharmaceutical companies operating within the European Union. Directive (EU)...

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...

The Dutch Medicines Evaluation Board (MEB) has recently published a new policy for Compassionate Use Programmes (CUP).[1] To support the...

On 23 December 2024, the Brussels enterprise court issued a first decision in Belgium on the so-called “SPC manufacturing waiver”. Under...

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...

In the rapidly evolving world of life sciences, merger control and foreign direct investment (“FDI”) regimes have emerged as key...

On September 12, 2024, the Court of Justice of the European Union (CJEU) delivered a ruling in a case involving Novo Nordisk AS...

In our earlier article, we discussed the implications of the European Commission’s legislative proposal from 26 April 2023 for the...

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

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

Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...

Introduction to the EU Pharmaceutical Reform After the European Commission published the proposed regulation regarding the EU...

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