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EU Court orders re-examination of interim relief granted in cases concerning the planned release of clinical trial data by the EMA
  • Sidley Austin LLP
  • European Union
  • December 11 2013

On November 28 2013, the Vice-President of the Court of Justice of the European Union (CJEU) set aside two orders by the President of the General

Extended protection for pharmaceutical patents in Europe: where are we now?
  • Arnold & Porter LLP
  • European Union
  • February 20 2014

The end of 2013 was a busy time at the Court of Justice of the European Union (CJ), with Rulings in a number of references from national courts

Transparency versus protection of business secrets
  • Dentons
  • European Union
  • January 27 2014

The effects of one or more new or already approved drugs are established, compared, and tested within the scope of clinical trials with medicinal

EMA clarifies new variation classification categories
  • Hogan Lovells
  • European Union
  • February 17 2014

On 10 February 2014, the European Medicines Agency ("EMA") published a revised Questions & Answers document. The document supports the implementation

Public-private EU partnership to fund stem cell banking and distribution
  • Shook Hardy & Bacon LLP
  • European Union
  • February 13 2014

A consortium of public and private partners has reportedly formed to establish a European induced pluripotent stem (iPS) cell bank with the goal of

WHOEU warns that overweight children becoming a “new norm”
  • Shook Hardy & Bacon LLP
  • European Union, Global
  • February 28 2014

The World Health Organization's Regional Office for Europe (WHOEU) reportedly warned attendees of a February 25-26, 2014, health conference held by

Re-branding of parallel imported medicines ruled unlawful - speciality European Pharma v Doncaster pharmaceuticals
  • D Young & Co
  • European Union, United Kingdom
  • March 3 2014

The parallel import of pharmaceuticals into the UK from other European Union (EU) countries has been common practice for over 30 years. Indeed, the

Case law: interpreting ‘health claims’ and ‘reduction of disease risk claims’ at the ECJ
  • Norton Rose Fulbright LLP
  • European Union
  • February 21 2014

The case law of the ECJ shows that the definitions of ‘health claim’ and ‘reduction of disease risk claim’ should be interpreted broadly. Even general

Personalized medicine ethics and regulation
  • CMS DeBacker
  • European Union
  • February 28 2014

As a whole new approach in illness treatment, personalized medicines will necessarily create new challenges for the whole healthcare system. From

EFSA and ECDC issue report on antimicrobial resistant bacteria
  • Shook Hardy & Bacon LLP
  • European Union
  • May 17 2013

The European Food Safety Authority (EFSA) and European Centre for Disease Control and Prevention (ECDC) have issued their third joint report "on