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Results: 1-10 of 31

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."


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 adopts joint procurement agreement for pandemic vaccines
  • Shook Hardy & Bacon LLP
  • European Union
  • April 17 2014

The European Commission has approved a joint procurement agreement under which all European Union (EU) member states will be able to "procure


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


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.”


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


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


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