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Results: 1-10 of 21

European nations sign MOU to manage life-science information
  • Shook Hardy & Bacon LLP
  • European Union
  • September 22 2011

Denmark, Finland, the Netherlands, Sweden, and the United Kingdom have reportedly signed a memorandum of understanding (MOU) with the European Molecular Biology Laboratory to create an infrastructure that would both manage and safeguard life-science data generated by publicly funded research


EU Court of Justice nixes patents for stem-cell inventions involving human embryo destruction
  • Shook Hardy & Bacon LLP
  • European Union
  • October 20 2011

The European Union (EU) Court of Justice has determined that EU patent law does not protect neural precursor cells and the processes for their production from embryonic stem cells


European Medicines Agency considers changes to biosimilar guidelines
  • Shook Hardy & Bacon LLP
  • European Union
  • October 20 2011

The European Medicines Agency (EMA) has published a concept paper outlining a number of clinical and non-clinical issues that need revision in its current “Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance"


EU Court of Justice interprets law extending patent protection for medicinal products
  • Shook Hardy & Bacon LLP
  • European Union
  • December 15 2011

The Court of Justice of the European Union (ECJ) has issued two rulings interpreting EU law at the request of British courts addressing whether drug makers can obtain a supplementary protection certificate (SPC), which extends patent protection, for products with active ingredients additional to those specified in the original patent


European Medicines Agency seeks feedback on biosimilars guideline
  • Shook Hardy & Bacon LLP
  • European Union
  • December 15 2011

The European Medicines Agency has issued for public comment a “Concept paper on the revision of the guideline on similar biological medicinal product.”


EC approves first gene therapy medicine in western world
  • Shook Hardy & Bacon LLP
  • European Union
  • November 15 2012

The European Commission has given final approval to uniQure’s gene therapy Glybera for the treatment of lipoprotein lipase deficiency patients with recurring acute pancreatitis


News bytes
  • Shook Hardy & Bacon LLP
  • European Union, USA
  • December 16 2010

The European Medicines Agency (EMA) adopts two draft guidelines as part of the regulatory approval process for certain biosimilar medicinal products


Report suggests Europe could become marine biotech leader by 2020
  • Shook Hardy & Bacon LLP
  • European Union
  • January 13 2011

The Marine Board of the European Science Foundation has released a report that suggests Europe could become a global leader in marine biotechnology by 2020, particularly by cultivating microalgae for fuel


EU legal services opinion could upset proposed GM laws
  • Shook Hardy & Bacon LLP
  • European Union
  • November 18 2010

According to media sources, the EU Council of Ministers' Legal Service has expressed "strong doubts" about the feasibility of a proposal that would allow individual member states to set their own policies for regulating genetically modified (GM) crops


European Commission study recommends changes to medical device and drug laws
  • Shook Hardy & Bacon LLP
  • European Union
  • May 17 2012

The European Commission has issued a report that analyzes the European Union’s (EU’s) REACH regulation, which addresses the registration, evaluation, authorization and restriction of chemical substances, and identifies overlap with other EU laws