BioTalk

8/4/2025 9:40:31 AM

Council adopts its position on EU pharmaceutical law reform: focus on antimicrobials and transferable data exclusivity vouchers

By Caroline Arrighi-Savoie Nour Saab Margot Pietri

This article is part of a series covering updates to the proposed European Union (EU) pharmaceutical legislation reform, known as the...

7/8/2025 8:00:47 AM

By Kevin Munungu

In 2023, the European Commission proposed a comprehensive update of the key EU pharmaceutical legislation (the "Pharma Package") to...

2/17/2025 8:30:15 AM

By Marc Martens Kevin Munungu

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

1/29/2025 11:15:40 AM

By Domien Op de Beeck Camille Vanpeteghem

On 23 December 2024, the Brussels enterprise court issued a first decision in Belgium on the so-called “SPC manufacturing waiver”. Under...

10/9/2024 1:41:38 PM

By Marc Martens Benedicte Mourisse

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