2/19/2025 2:57:21 PM Increased risks for Australian life sciences businesses under the EU’s modernised product liability regime By Rebecca Currey Tom Johnston A recent EU directive will have significant consequences for Australian life sciences companies operating in Europe. Directive 2024/2853...
2/17/2025 8:30:15 AM A Sea Change for Pharma: EU's Urban Wastewater Treatment Directive and its Cost Implications By Marc Martens Kevin Munungu Lungungu A new European directive is set to significantly impact pharmaceutical companies operating within the European Union. Directive (EU)...
1/30/2025 9:28:21 AM New Policy for Compassionate Use Programs By Hester Borgers Maud van Haaren The Dutch Medicines Evaluation Board (MEB) has recently published a new policy for Compassionate Use Programmes (CUP).[1] To support the...
10/14/2024 9:22:12 AM Fight against medicine shortages: the French Medicines Agency (ANSM) imposes fines totalling €8 million By Caroline Arrighi-Savoie Johanna Harelimana Nahla Ghouali On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...
10/9/2024 1:41:38 PM Case C-237/22 of the CJEU – Clarification of the concepts of “Significant Benefit” and “Clinical Superiority” By Marc Martens Benedicte Mourisse The CJEU brings clarity, on the concepts of “Significant Benefit” and “Clinical Superiority” with respect to Orphan Medicinal Products...
9/17/2024 11:38:01 AM The DNA of Life Sciences Deals By James Baillieu Maria John The life sciences sector, comprising of sub-sectors like pharmaceuticals, medical devices, diagnostics and services, aims to cure disease...
8/8/2024 4:25:29 PM New EU Pharmaceutical Reform: Key Changes and Impacts on Orphan Medicinal Products By Anna Koster Hester Borgers Introduction to the EU Pharmaceutical Reform After the European Commission published the proposed regulation regarding the EU...
7/30/2024 2:33:34 PM New UK government’s plans for life sciences: the people and policies explained By Sally Shorthose Heidi Hurdle Charlotte Getz The UK life sciences industry takes centre-stage in two of the new Labour government’s “Five Missions For National Renewal”: economic...