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News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • October 30 2014

The U.S. Food and Drug Administration (FDA) makes available Guidance for Industry titled "Circumstances that Constitute Delaying, Denying, Limiting


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • July 17 2014

The U.S. Food and Drug Administration issues guidance titled "Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal, Food


Biosimilar development costs may affect savings potential
  • Shook Hardy & Bacon LLP
  • USA
  • January 30 2014

According to Pharm Exec Senior Editor Ben Comer, the biosimilars that were supposed to save consumers and taxpayers money as "the first wave of


Court denies Myriad’s request to enjoin sale of rival BRCA1BRCA2 tests
  • Shook Hardy & Bacon LLP
  • USA
  • March 20 2014

A federal court in Utah has denied the request for a preliminary injunc- tion filed by Myriad Genetics against a rival company that offered tests


News Bytes
  • Shook Hardy & Bacon LLP
  • USA
  • April 3 2014

The U.S. Food and Drug Administration (FDA) announces the availability of draft Guidance for Industry titled "Labeling for Human Prescription Drug


SCOTUS sides with FTC in reverse payment deals
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

A divided U.S. Supreme Court has determined that patent-infringement settlement agreements requiring the patentee to pay the claimed infringer


U.S. Supreme Court issues ruling on patentability of human genes
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

The U.S. Supreme Court has determined that while human genes and the information they encode are not patent eligible, despite the effort required to


Australian court finds human gene mutation to be patentable
  • Shook Hardy & Bacon LLP
  • Australia, USA
  • September 11 2014

A full panel of the Federal Court of Australia has upheld its earlier ruling that an isolated but naturally occurring nucleic acid, BRCA1, can be


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • September 11 2014

The U.S. Patent and Trademark Office (USPTO) seeks comments on the estimated time burdens of revisions to a currently approved information collection


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • May 1 2014

The U.S. Food and Drug Administration (FDA) seeks input "on the design and conduct of the postmarketing requirements (PMRs) for the class-wide