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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.
20 February 2018 - Posted by: Eveline Van Keymeulen
In its judgment dated 7 December 2017 (Case C-329/16) the Court of Justice of the EU – rather unsurprisingly – confirmed that software which uses patient-specific data to aid prescription by detecting contra-indications, interactions with medicinal products and excessive doses falls within the definition of a medical device for the purposes of the Medical Devices Directive. › Read More
15 February 2018 - Posted by: Marco de Morpurgo
Today, Italian Law 3/2018 – mandating the governement to reform the Italian clinical trial rules – entered into force. The Italian government now has 12 months to revise the regulatory framework applicable to clinical trials conducted in the country. The legislative mandate to the government includes an alignment of the Italian clinical trial rules with the › Read More
14 February 2018 - Posted by: Michael Bloch
After spending all day last Wednesday at Biotech & Money’s IPO workshop presenting and talking to Life Sciences start ups about their IPO plans, we thought it might be interesting to bring together some of our key thoughts on IPO preparedness. Companies thinking about an IPO can never start planning too early. IPO planning and › Read More
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