BioTalk

This article is part of a series on the final agreement reached regarding the pharmaceutical package, which is currently awaiting formal...

The National Commission into the Regulation of AI in Healthcare, established by the Medicines and Healthcare products Regulatory Agency...

Following our recent BioTalk article, Ambient Scribing in the NHS: A Compliance Framework Suppliers Cannot Ignore (30 July 2026), a...

After more than two decades, the legal architecture governing medicinal products in the European Union is being fundamentally rebuilt....

Your pipeline asset took years to develop. The partnership that was supposed to bring it to market has broken down. Now a tribunal needs...

A UK judge has for the first time granted a website blocking injunction targeting counterfeit and unlicensed prescription-only medicines....

There is a fair chance that the seedless mandarins in your local supermarket recently featured in a case at the English High Court. The...

The ICO is currently consulting on updates to its guidance on the Research, Archiving and Statistics (RAS) provisions, following the Data...

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...

England’s National Health Service (NHS) is seen as one of the world’s most ambitious and comprehensive healthcare systems, but has been...

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

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

The amount of capital required to develop and bring a drug to market is significant. It is estimated that it costs US$1-2 billion to...