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Europe developing more specific criteria for biosimilar drug safety data
  • Bereskin & Parr LLP
  • European Union
  • May 5 2014

Immunogenicity of biosimilar medicines has been a key concern for regulators. They want to minimize risk that a patient receiving a biosimilar

Europe continuing to develop biosimilar guidance
  • Bereskin & Parr LLP
  • European Union
  • April 28 2014

The European Medicines Agency ("EMEA") continues to be a leader in developing guidance to industry on biosimilar approvals. The EMEA is currently

EU political update: 7 - 11 April 2014
  • Clifford Chance LLP
  • European Union
  • April 7 2014

On 3 April 2014, the European Parliament voted in favour of a new Regulation creating a single market for telecoms. The Regulation introduces a ban

Medical devices and 3D printing
  • Taylor Wessing
  • European Union, United Kingdom
  • September 30 2013

3D printing is an exciting technology that is developing rapidly. While high performance industrial systems can cost between £10,000 and £700,000

CJEU hands down landmark judgment in AstraZeneca competition case
  • Gowling WLG
  • European Union
  • December 7 2012

Yesterday, the Court of Justice of the European Union (CJEU) handed down its judgment in respect of AstraZeneca's appeal against its 52.5 million fine imposed by the European Commission for abuse of a dominant position

En bref
  • CMS DeBacker
  • Belgium, European Union
  • January 25 2013

Un projet de loi réglementant les qualifications requises pour poser des actes de médecine esthétique non chirurgicale et de chirurgie esthétique a

Horsemeat investigation spreads across EU
  • Shook Hardy & Bacon LLP
  • European Union
  • February 15 2013

Citing public concerns about the presence of horsemeat in beef products, European Union (EU) Health and Consumer Policy Commissioner Tonio Borg

A consistently broad interpretation of "health claim" emerges in Europe
  • Taylor Wessing
  • European Union, Germany
  • April 30 2014

A decision recently handed down by the German Federal Court of Justice (Bundesgerichtshof - BGH) has confirmed the broad interpretation of the term

Pharma patents: the EU court rules in favor of functional claiming
  • Nctm Studio Legale
  • European Union, United Kingdom
  • January 9 2014

On December 12, 2013, in case C-49312, the European Court of Justice stated that the grant of a supplementary Protection Certificate (SPC) can be

Publication of and access to clinical-trial data update
  • Taylor Wessing
  • European Union
  • January 7 2014

On 5th December 2013 the Court of Justice of the European Union (CJEU) published its decision on the appeal of the European Medicines Agency (EMA) to