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Results: 1-10 of 160

District court grants partial dismissal in Part DMedicaid case alleging false comparative marketing claims
  • Sidley Austin LLP
  • USA
  • August 25 2015

On August 20, 2015, the District of New Jersey granted in part and denied in part defendants' motion to dismiss allegations that by making


China reforms its review and approval systems for drugs and medical devices
  • Sidley Austin LLP
  • China
  • August 19 2015

On August 18, 2015, China's State Council issued an important document, the Opinions on Reforming Review and Approval Process for Drugs and Medical


District Court holds that First Amendment bars prosecution for misbranding where conduct is truthful, non-misleading speech about off-label uses, declines to rule on potential FCA liability
  • Sidley Austin LLP
  • USA
  • August 10 2015

On August 7, in the first Caronia progeny case, the United States District Court for the Southern District of New York (Engelmayer, J.) granted


FDA loses Amarin litigation; court grants preliminary relief
  • Sidley Austin LLP
  • USA
  • August 10 2015

In a widely anticipated ruling on Friday, in the ongoing Amarin litigation against the United States Food and Drug Administration (FDA), Judge


Court dismisses GMP-based FCA claims with prejudice
  • Sidley Austin LLP
  • USA
  • June 16 2015

On Friday, the Northern District of California dismissed with prejudice claims alleging that a failure to obtain supplemental approval for major


New EU Guideline facilitates global development of biosimilars
  • Sidley Austin LLP
  • European Union
  • May 4 2015

On April 30, 2015, a new EU Guideline on biosimilar medicines took effect. The new Guideline defines a number of concepts applied by the EMA in its


Court rejects off-label promotion allegations due to failure to cite actual false claim submissions; allows retaliation claims to proceed
  • Sidley Austin LLP
  • USA
  • April 2 2015

On March 27, 2015, a federal court in the Southern District of Ohio granted in part and denied in part a motion to dismiss a qui tam suit alleging


A year of global change 2015: what multinational life sciences companies should expect in China
  • Sidley Austin LLP
  • China
  • March 4 2015

With China marching into the Year of the Ram, multinational life sciences companies should anticipate and be prepared for regulatory changes and


FDA addresses oversight of general wellness products, device accessories
  • Sidley Austin LLP
  • USA
  • January 22 2015

On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


EU publishes new GMP Regulation and guidelines
  • Sidley Austin LLP
  • European Union
  • December 11 2014

The European Commission's long-awaited Delegated Regulation on Good Manufacturing Practice (GMP) principles and guidelines for active substances for