BioTalk

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

* 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...

The Federal Court of Australia has confirmed that an extension of patent term for Novo Nordisk's patent claiming liraglutide plus...

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...

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

In recent decades, venture capital (VC) has played an increasingly important role in the high-risk and high-reward life sciences sector....

On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...

The CJEU brings clarity, on the concepts of “Significant Benefit” and “Clinical Superiority” with respect to Orphan Medicinal Products...

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...