BioTalk

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...

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...

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

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

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

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...

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

There is a huge cost of bringing a pharmaceutical product to market, with estimates ranging from US$1-2 billion to take a product from...