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Results: 1-10 of 117

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
  • 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


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


Indian Supreme Court rules Novartis cancer drug change not patentable
  • Shook Hardy & Bacon LLP
  • India
  • April 4 2013

The Supreme Court of India has rejected the patent application filed by Novartis AG for a beta crystalline form of its cancer drug Gleevec, also


News Bytes - April 4, 2013
  • Shook Hardy & Bacon LLP
  • USA
  • April 4 2013

The U.S. Food and Drug Administration (FDA) issues draft guidance titled "Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors


News Bytes - April 18, 2013
  • Shook Hardy & Bacon LLP
  • USA
  • April 18 2013

The U.S. Department of Commerce announces the winners of the U.S. Patent and Trademark Office's Patents for Humanity pilot program. The awards


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


Myriad Genetics, gene by gene settle BRCA infringement dispute
  • Shook Hardy & Bacon LLP
  • USA
  • February 13 2014

According to a joint news release, Myriad Genetics, Inc. and other owners of the BRCA1 and BRCA2 gene patents have settled patent infringe- ment


News Bytes
  • Shook Hardy & Bacon LLP
  • USA
  • February 13 2014

The U.S. Patent and Trademark Office requests comments by March 3, 2014, on the revision of a previously approved information collec- tion concerning