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This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
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In recent decades, venture capital (VC) has played an increasingly important role in the high-risk and high-reward life sciences sector....
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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...
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On September 12, 2024, the Court of Justice of the European Union (CJEU) delivered a ruling in a case involving Novo Nordisk AS...
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In our earlier article, we discussed the implications of the European Commission’s legislative proposal from 26 April 2023 for the...
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This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
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Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...
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Introduction to the EU Pharmaceutical Reform After the European Commission published the proposed regulation regarding the EU...
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The UK life sciences industry takes centre-stage in two of the new Labour government’s “Five Missions For National Renewal”: economic...
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In May 2024, the Dutch government published the draft bill for the new Cybersecurity Act (Cyberbeveiligingswet – “CSA”) for consultation...
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This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
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In April 2024, the European Parliament voted to adopt a revised version of a new Pharma Directive, part of the European Commission’s...
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On 10 April 2024, the European Parliament adopted its position at first reading on two European Commission proposals to revise the EU’s...
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On April 10, 2024, the European Parliament voted to adopt a revised version of the European Commission’s proposed reforms to...
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Legislative process On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and...