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Results: 1-10 of 19

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

EU medical device manufacturers address plan to change regulatory directives

  • Shook Hardy & Bacon LLP
  • -
  • European Union
  • -
  • February 8 2013

Eucomed, an organization that represents the interests of the European medical device industry, has issued a position paper that assesses a number of

Researchers protest ECJ advocate general’s position on patenting stem cell technologies

  • Shook Hardy & Bacon LLP
  • -
  • European Union
  • -
  • May 5 2011

Viewing the issue as a matter of morality, the advocate general of the European Court of Justice (ECJ) recently delivered a non-binding ruling that would render unpatentable the cells removed from the human embryo at the blastocyst stage, because the removal involves the embryo's destruction

Europe sees strong growth in biotech patent filings

  • Shook Hardy & Bacon LLP
  • -
  • European Union
  • -
  • April 21 2011

According to a news source, biotechnology patent applications filed with the European Patent Organization (EPO) grew more than 42 percent in 2010 from the previous year

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 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

European Commission proposes regulation on access to genetic resources

  • Shook Hardy & Bacon LLP
  • -
  • European Union
  • -
  • October 18 2012

To carry out European Union (EU) obligations under the Nagoya Protocol on Access to Genetic Resources and Benefit-Sharing, the European Commission (EC) has proposed a regulation that would ensure that only legally acquired genetic resources and associated traditional knowledge are used in the EU and that such resources are fairly and equitably shared

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