BioTalk

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

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...

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...

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...