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Results: 1-10 of 31

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


R&D for new drugs to treat “neglected diseases” continues to lag
  • Shook Hardy & Bacon LLP
  • European Union
  • October 31 2013

European researchers writing in a medical journal have found that just 4 percent of new therapeutic products registered with drug regulatory


EU agency will reinstate Ranbaxy’s GMP certificate
  • Shook Hardy & Bacon LLP
  • European Union, India
  • June 12 2014

The European Medicines Agency (EMA) has reportedly concluded its investigation of alleged non-compliance with good manufacturing practice (GMP) at


EU Court of Justice Advocate General issues ruling on Stem Cell patentability
  • Shook Hardy & Bacon LLP
  • European Union, United Kingdom
  • August 7 2014

In a non-binding ruling, Advocate General Cruz Villalón of the EU Court of Justice has determined that unfertilized human ova whose division


European markets less than enthusiastic over biosimilars
  • Shook Hardy & Bacon LLP
  • European Union, USA
  • December 12 2013

While Europe has had a regulatory approval pathway for biosimilar drug products for some years, their use reportedly remains anemic. Physicians are


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


April vote scheduled before EU Parliament on clinical trial data accessibility
  • Shook Hardy & Bacon LLP
  • European Union
  • March 20 2014

The European Parliament has postponed until April 2, 2014, debate on amended draft legislation (20120192 (COD)) that would require phar- maceutical


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


European Parliament approves second medicines R&D initiative
  • Shook Hardy & Bacon LLP
  • European Union
  • May 1 2014

With opposition from the Green group, the European Parliament has apparently approved the second Innovative Medicines Initiative (IMI2), a 3


EU trade group issues voluntary code for disclosures by pharma companies
  • Shook Hardy & Bacon LLP
  • European Union
  • July 11 2013

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a "Code on Disclosure of Transfers of Value from