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Pharmaceutical & medical device regulatory update, vol. II, issue 8
  • Jones Day
  • European Union, USA
  • April 24 2015

The first U.S. biosimilar product Zarxio overcame another legal challenge earlier this month when a federal court in California denied a motion to

FDA and EMA clusters
  • Taylor Wessing
  • European Union, USA
  • July 27 2015

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regularly collaborate on a number of regulatory topics in the form

Pharmaceutical & medical device regulatory update, vol. II, issue 11
  • Jones Day
  • China, European Union, USA
  • June 9 2015

The U.S. Department of Health and Human Services ("HHS") recently released its Agency Rule ListSpring 2015, which includes, among other things

Cyber security rules ‘under observation’
  • Freshfields Bruckhaus Deringer LLP
  • Asia-Pacific, European Union, USA
  • May 18 2015

A study released in May 2015 of 90 covered healthcare organisations under the US Health Insurance Portability and Accountability Act

Privacy & Cybersecurity Update - January 2016
  • Skadden Arps Slate Meagher & Flom LLP
  • European Union, USA
  • January 31 2016

U.S. and EU negotiators have failed to meet a January 31 deadline for agreeing on a replacement Safe Harbor framework to allow companies to send

IREG update
  • Dentons
  • European Union, USA
  • December 4 2015

The US Treasury Department and US Trade Representative (USTR) recently announced controversial plans to negotiate a “covered agreement” on insurance

Privacy and Cybersecurity Update April 2016
  • Skadden Arps Slate Meagher & Flom LLP
  • European Union, USA
  • April 30 2016

Following its December announcement that a draft regulation had been completed, the European Parliament voted on April 14, 2016, to formally approve

IP in depth: patentable biotechnology a comparative analysis of key markets
  • Fisher Adams Kelly Callinans
  • Australia, European Union, New Zealand, USA
  • March 31 2015

There is extraordinary complexity and optimization underlying even comparatively 'simple' organisms. These powerful biological products and processes

Enbrel biosimilar in Europe and US
  • Patterson Belknap Webb & Tyler LLP
  • European Union, USA
  • December 1 2015

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion

Royalty obligations when patents are revoked
  • Bristows LLP
  • European Union, USA
  • April 6 2016

Claire Smith says that although the Advocate General's opinion in Genentech may not come as much of a surprise, it highlights to lawyers the