BioTalk

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...

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...

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...

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...