BioTalk

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...

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...

The life sciences sector, comprising of sub-sectors like pharmaceuticals, medical devices, diagnostics and services, aims to cure disease...

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...

In May 2024, the Dutch government published the draft bill for the new Cybersecurity Act (Cyberbeveiligingswet – “CSA”) for consultation...

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