/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-10-15-07-08-25-298-670e14e9b3157324cf24ba0c.jpg)
On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...
BioTalk
Powered by Bird & Bird
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-10-09-13-34-10-162-67068652a75ae96e1ecfeab1.png)
The CJEU brings clarity, on the concepts of “Significant Benefit” and “Clinical Superiority” with respect to Orphan Medicinal Products...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-10-02-07-17-04-998-66fcf370c94291d0508f42b6.png)
In the rapidly evolving world of life sciences, merger control and foreign direct investment (“FDI”) regimes have emerged as key...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-09-30-13-23-11-511-66faa63f503db80eba8a0208.png)
On September 12, 2024, the Court of Justice of the European Union (CJEU) delivered a ruling in a case involving Novo Nordisk AS...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-09-19-10-49-31-417-66ec01bb8372d7a719447130.jpg)
In our earlier article, we discussed the implications of the European Commission’s legislative proposal from 26 April 2023 for the...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-09-17-11-36-19-180-66e969b30513207aadd84e6a.jpg)
The life sciences sector, comprising of sub-sectors like pharmaceuticals, medical devices, diagnostics and services, aims to cure disease...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-09-11-13-03-24-534-66e1951c46210d18f4bb2b01.png)
This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-09-05-13-56-44-784-66d9b89c9c4fc63968366cbe.png)
On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...
/Passle/MediaLibrary/Images/2024-07-30-14-32-24-888-66a8f978926269fa77476ca6.jpg)
Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...
/Passle/MediaLibrary/Images/2024-08-02-14-59-30-386-66acf45250478b62ec64232d.jpg)
Introduction to the EU Pharmaceutical Reform After the European Commission published the proposed regulation regarding the EU...
/Passle/MediaLibrary/Images/2024-07-30-14-32-46-741-66a8f98e926269fa77476cf4.jpg)
The UK life sciences industry takes centre-stage in two of the new Labour government’s “Five Missions For National Renewal”: economic...
/Passle/MediaLibrary/Images/2024-07-30-11-42-54-669-66a8d1be906525afd4dbcf24.jpg)
In May 2024, the Dutch government published the draft bill for the new Cybersecurity Act (Cyberbeveiligingswet – “CSA”) for consultation...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-07-22-14-53-30-038-669e726a232fa19018d6af63.jpg)
This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-07-22-14-57-50-346-669e736e232fa19018d6b24a.jpg)
In April 2024, the European Parliament voted to adopt a revised version of a new Pharma Directive, part of the European Commission’s...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-07-22-15-25-51-176-669e79ff0e665f7cf84e3915.jpg)
On 10 April 2024, the European Parliament adopted its position at first reading on two European Commission proposals to revise the EU’s...
/Passle/65b10a249576f7f0a5a2f163/MediaLibrary/Images/2024-06-22-10-07-21-296-6676a2598e50ec2db9736d48.jpg)
On April 10, 2024, the European Parliament voted to adopt a revised version of the European Commission’s proposed reforms to...