BioTalk

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....

 * This article was co-authored with Olivia Zhao from Bird & Bird Lawjay Shanghai association team.  On 19 March 2025, the National...

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

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...