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Update on the EU Clinical Trials Portal and Database
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • June 15 2018

While the Clinical Trials Regulation (EU No. 5362014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6


Former FDA Senior Regulatory and Policy Counsel Bryant Godfrey Joins Arnold & Porter
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • June 12 2018

Arnold & Porter announced today that Bryant M. Godfrey, former Senior Regulatory Counsel in the US Food and Drug Administration’s Centers for Drug


Consultation on duplicate marketing authorisations in the EU
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • June 5 2018

The European Commission has published a consultation on proposed changes to its 2011 Note on the handling of duplicate marketing authorisations. The


Shire v EMA: European General Court provides clarification for designation of orphan medicinal products
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • May 30 2018

On 22 March 2018, the European General Court handed down its judgment in Case T-8016 Shire Pharmaceuticals Ireland v EMA. Shire had sought annulment


England & Wales High Court Judgment in metal on metal hip group litigation
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • May 23 2018

Judgment was handed down on 21 May in the DePuy Pinnacle Metal on Metal Hip group litigation: Gee & Others v DePuy International Limited 2018 EWHC


National Right to Try Legislation Passes Congress
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • May 23 2018

On May 22, 2018, the United States House of Representatives passed 250-169 the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Mathew Bellina


UK Mergers, Military and Technology
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom
  • May 17 2018

The UK's merger control regime is changing as of 11 June 2018 in industries that are sensitive to national security concerns. The main aim is to allow


West Virginia High Court Reaffirms Traditional Limits on Innovator Liability for Brand Manufacturers
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • May 16 2018

On May 11, 2018, the West Virginia Supreme Court held that manufacturers of brand-name pharmaceutical products cannot be held liable for injuries


UK Economic Crime Group: Enforcement Update Part 2
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom
  • May 15 2018

Unexplained Wealth Orders (UWOs) came into force in the UK on 31 January 2018 under the Criminal Finances Act 2017 and have the potential to be a


UK Economic Crime Group: Enforcement Update Part 1
  • Arnold & Porter Kaye Scholer LLP
  • United Kingdom
  • May 15 2018

In May 2017, the High Court released its judgment in SFO v ENRC, which was examined in detail in our June 2017 Newsletter. The judgment has been