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The EPO Board of Appeal (“BoA”) recently rejected a patent application relating to pig-human chimeras, concluding that the invention was...
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On 11 December 2024, the MHRA published an updated roadmap for the future of the regulatory framework for medical devices in the UK,...
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* This article was co-authored with Olivia Zhao from Bird & Bird Lawjay Shanghai association team. On 3 January 2025, the General Office...
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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...
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Companies in the life sciences sector and its sub-sectors, including pharmaceuticals, medical devices, diagnostics and services, are...
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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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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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The World Health Organisation (WHO) has published regulatory considerations on artificial intelligence (AI) for healthcare in October...
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Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
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Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...
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To add to all the chatter about AI, let’s talk about AI as a medical device. Last month, the Medicines & Healthcare products Regulatory...
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Telemedicine has been available to healthcare providers for several years. However, it was not until quite recently that the field of...
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The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased focus on the risks for medical...
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The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction of a 12-month extension to the...
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The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure ceiling for medical devices in...