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Update on regulatory changes for software-based medical devices
Posted: 16/01/2025
With the emergence of artificial intelligence (AI) and other machine learning methods, software-based medical devices are a substantial growth area in the medical devices sector and an increasingly common feature in everyday life. With this in mind, the Medicines & Healthcare Regulatory Agency (MHRA) recently published a consultation entitled......>>
Sustainable practices in life sciences: meeting ESG standards
Posted: 12/12/2024
In November, the International Organization for Standardization (ISO) launched the ISO ESG Implementation Principles (IWA 48) at the 2024 COP 29 UN Climate Change Conference. Nearly 2,000 experts from standards organisations around the globe collaborated on these principles, to define and examine each aspect of environmental, social......>>
Clinical trials and AI – legal challenges and pitfalls: Penningtons Manches Cooper’s inaugural life sciences conference
Posted: 12/12/2024
The life sciences sector group at Penningtons Manches Cooper chose the topic of AI for its inaugural life sciences conference, given its relevance to all life sciences companies wishing to put their products into clinical trials, both now and in the future. The conference began with its keynote, ‘Unlocking Potential - Using AI in Clinical Research’......>>
Updates to the ABPI code 2024 – what you need to know
Posted: 06/12/2024
The much awaited 2024 edition of the Association of British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry came into effect on 1 October 2024 following the conclusion of the public consultation period. It replaces the previous version from 2021, and promises to increase the standards expected of pharmaceutical......>>
Intellectual property: the bedrock of innovation
Posted: 05/12/2024
Intellectual property (IP) is often the most valuable asset for early-stage companies, particularly those in the technology and life sciences sectors. IP rights not only provide legal protection for an innovation but can also help establish brand identity and be used as collateral to secure financing. IP does not just mean patents but also includes copyright......>>
Fuelling growth: funding your venture
Posted: 28/11/2024
A distressingly large part of a start-up CEO’s time is spent in the funding process – seeking the investment needed to get to the next stage on the journey. Penningtons Manches Cooper’s corporate team advises businesses on all stages of the funding cycle – from pre-seed and seed, through larger series A rounds and beyond to IPO. It’s an almost......>>
In pursuit of Grail – recent changes in European merger control
Posted: 08/11/2024
The curtain has fallen on the final act of the long-running drama of the attempted acquisition of Grail by Illumina. To recap: Illumina, the leading player for next-generation DNA sequencing systems with an 80% global market share, had acquired Grail in 2021. Five years previously, Grail had actually been spun out from Illumina as a start-up......>>
UK Patents Court - The Enzalutamide Decision
Posted: 17/10/2024
In this video, Dr Duncan Curley discusses the recent Enzalutamide decision made by the UK Patents Court on October 8th, 2024. This case concerned one of the leading prostate cancer treatments, Astellas’ Xtandi®.
AI and the use of data in the life sciences sector
Posted: 24/06/2024
AI is having a major impact on life sciences. Its ability to process vast quantities of data and information faster than humans has numerous valuable applications in the sector, from creating new drugs and targets, to use in medical devices to diagnose disease, as well as monitoring patients remotely, and analysing data, for example from MRI......>>
Penningtons Manches Cooper advises Delta Hat on acquisition by Petauri
Posted: 20/06/2024
The corporate team at Penningtons Manches Cooper has advised the shareholders of Delta Hat on its acquisition by Petauri. Delta Hat provides industry leading analysis and health economic modelling to the life sciences and healthcare sectors. Petauri is a purpose-built pharmaceutical services platform based in Nashville, Tennessee, USA......>>
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