Enter your email address in the box to the right of this page to receive email updates from the Life Sciences Hub when new content is published.
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 March 2021 - Posted by: Thomas Masterman
Key points Working group’s goal is “concrete and actionable” updates to pharmaceutical merger analysis. Focus will include new theories of harm beyond the traditional approach of assessing overlaps in products and pipeline products. Stated intention is to take an “aggressive” approach to tackling anticompetitive pharmaceutical mergers. Overview On March 16, the U.S. Federal Trade Commission › Read More
12 March 2021 - Posted by: Rafi Allos
As next generation Covid-19 vaccine developers consider whether ethical and practical clinical efficacy trials can be conducted, they might consider whether vaccine efficacy can instead be inferred. We consider the alternative routes for vaccine developers of using an immune correlate of protection or immunobridging studies and some potential risks associated with such approaches. Setting the › Read More
05 March 2021 - Posted by: Nieke Vanavermaete
Consent Forms (ICF) to include an explicit reference as to the possibility that EU inspectors would have access to medical records and personal data of clinical trial participants. In February 2021, the European Medicines Agency updated its guidance in the form of questions and answers (Q&As) on Good Clinical Practice (GCP). GCP is a code › Read More
03 March 2021 - Posted by: Nieke Vanavermaete
In 2018, the EU Commission adopted a “Paper on the obligation of continuous supply to tackle the problem of shortages of medicines”, providing that Member States may take measures to prevent or address shortages of medicines by restricting the free movement of goods within the EU. While Member State may restrict the supply of medicinal › Read More
01 March 2021 - Posted by: Marton Eorsi
Now that the COVID-19 vaccine contract between the EU and AstraZeneca has been published, we take a look at it and the “Best Reasonable Efforts” provisions. The production issues facing the roll-out of the EU vaccination programme have led some to question the centralised approach taken by the European Commission in its procurement of the › Read More