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Results: 1-10 of 117

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


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • August 7 2014

The U.S. Patent & Trademark Office (USPTO) selects 19 law schools to join its Law School Clinic Certification Pilot Program. Four of the law schools


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


Analysts predicts biosimilars boom as biologics reach new patent cliff
  • Shook Hardy & Bacon LLP
  • Global
  • August 7 2014

A new Allied Market Research (AMR) report predicts that the global biosimilars market, which accounted for $1.3 billion in 2013, will generate $35


EU Court of Justice Advocate General issues ruling on Stem Cell patentability
  • Shook Hardy & Bacon LLP
  • European Union, United Kingdom
  • August 7 2014

In a non-binding ruling, Advocate General Cruz Villalón of the EU Court of Justice has determined that unfertilized human ova whose division


Biosimilars market expected to increase by billions over next four years
  • Shook Hardy & Bacon LLP
  • USA
  • April 7 2011

Market analysts have apparently forecast huge growth in the market for biosimilars due to the upcoming loss of patent exclusivity for a number of branded drugs


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • April 7 2011

The U.S. Patent & Trademark Office implements prioritized examination of patent applications


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The U.S. Food and Drug Administration (FDA) announces the availability of draft Guidance for Industry titled "Labeling for Human Prescription Drug