BioTalk

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...

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...

In April 2024, the European Parliament voted to adopt a revised version of a new Pharma Directive, part of the European Commission’s...

On 10 April 2024, the European Parliament adopted its position at first reading on two European Commission proposals to revise the EU’s...