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For those with an interest in life sciences, the rise to prominence of CRISPR, a transformational development in the field of molecular biology and genetics, has been impossible to ignore.
In this paper we consider how a new generation of VR equipment promises to fundamentally change consumer experiences of virtual environments, including in the Life Sciences sector.
A rapidly-changing cybersecurity risk landscape for Life Sciences companies.
Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.
13 February 2018 - Posted by: Steven Baldwin
The Appellants in this action, Sandoz and Hexal, are appealing Arnold J’s decision to uphold SPC/GB07/038 on the basis that the Markush formulae in the basic patent are sufficient to satisfy the requirements of Article 3(a) of the SPC Regulation (Regulation (EC) No 469/2009). We have previously commented on the facts here and the first › Read More
06 February 2018 - Posted by: Marco de Morpurgo
Today, the General Court delivered three landmark judgments relating to transparency of clinical trial data in the EU. The long-awaited rulings clarify the scope of commercial confidentiality with regard to data pertaining to centrally approved medicinal products and included in the MA application dossier. The three rulings uphold the European Medicines Agency (EMA)’s decisions to › Read More
02 February 2018 - Posted by: Eveline Van Keymeulen
On 22 December 2017, the National Agency for Medicines and Health Products Safety (ANSM) published guidelines to assist pharmaceutical companies when reporting intentional non-compliant prescribing or use of medicinal products. Non-compliance can in particular relate to the indication, patient characteristics, administration route or posology of the products. French law requires pharmaceutical companies to report to › Read More
29 January 2018 - Posted by: Tine Carmeliet
In early January 2018, the Belgian Minister of Health published an announcement on the creation of a digital platform called the “Personal Health Viewer”. The goal of this digitalisation initiative is to engage patients in the management of their own health. In particular, the platform will enable patients to access their own medical file online and › Read More
24 January 2018 - Posted by: Jacqueline Bore
Yesterday, the European Medicines Agency (EMA) announced its plan to consult all marketing authorisation holders of centrally authorised products that are located in the UK or who have an important part of their site operations in the UK on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of › Read More