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Results: 1-10 of 19

Joint public meeting to focus on bridging nanotechnology research

  • Shook Hardy & Bacon LLP
  • -
  • European Union, USA
  • -
  • February 24 2011

The National Nanotechnology Coordination Office has announced that it will spearhead a public meeting to focus on "environmental health and safety questions for nanomaterials and nanotechnology-enabled products" and to "encourage joint US-EU programs of work that would leverage resources."

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

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

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

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"

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 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.”

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

EU regulators charge pharma companies with antitrust violations in pay-for-delay deals

  • Shook Hardy & Bacon LLP
  • -
  • European Union
  • -
  • August 2 2012

The European Commission (EC) has reportedly charged nine pharmaceutical companies with breaches of European Union (EU) antitrust rules for entering pay-for-delay deals with generic competitors