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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.
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.
23 July 2020 - Posted by: Lars Braams
Two anonymous whistleblowers informed the media about certain serious flaws with respect to Terumo’s syringes, stents and catheters. In the first broadcast of the Dutch TV show “EenVandaag” by AVROTROS it is stated that the syringes can contain (liquid) glue that might contaminate the medicine and the patient. In the second broadcast the quality control › Read More
20 July 2020 - Posted by: Lars Braams
A Marketing Authorization (MA) is required for selling melatonin in dosages above 0.3 mg. The Dutch Health Care Inspectorate (IGZ) warned repeatedly that it will enforce against the sale of such products, without having an MA. On 16 June, the administrative court of Amsterdam published a decision according to which the decision of the Dutch › Read More
14 July 2020 - Posted by: Charles Tuffreau
In a landmark decision dated 9 July 2020 concerning the Santen case (C‑673/18), the Grand Chamber of the CJEU clearly reverses the Neurim decision (C‑130/11) and ruled that a MA cannot be considered to be the first MA, for the purpose of Article 3(d), where it covers a new therapeutic application of an active ingredient › Read More
12 June 2020 - Posted by: Zara Sproul
In recent weeks and months, the life sciences sector has been the focal point of efforts to respond to the Covid-19 threat. While these efforts have – justifiably – occupied many of the headlines, this blog post looks at the impact of the pandemic on “non-Covid” focused clinical trials and steps taken to limit disruption › Read More
11 June 2020 - Posted by: Jeanne Fabre
On 29 April 2020, the French High Health Authority (HAS) updated its guide on national early meetings for medicines evaluation. As part of its action plan for innovative medicines and its work programme presented at the beginning of 2020, the HAS has revised its guide to early meetings which aims to support businesses in the › Read More