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Results: 1-10 of 346

U.S. biotech sector shows IPO gains in 2013

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 6 2013

According to Reuters, 14 biotech companies have gone public so far in 2013, marking a possible turnaround for the sector with a rising stock market

News Bytes - June 6, 2013

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 6 2013

The U.S. Patent and Trademark Office creates the After Final Consideration Pilot Program 2.0 which modifies and extends a program designed to

FDA seeks premarket notification for mobile medical application

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 6 2013

The U.S. Food and Drug Administration (FDA) has informed an India-based company that it is expected to file a premarket notification as to its uChek

Universities abroad experiment with no-fee licensing to drive biotech partnerships

  • Shook Hardy & Bacon LLP
  • -
  • Australia, Canada, European Union, United Kingdom, USA
  • -
  • May 16 2013

Universities in Australia, Canada, Europe, and the United Kingdom have reportedly embraced a 2010 Glasgow University initiative under which companies

French company prevails in dispute with FDA over drug-classification ruling

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2012

A federal court in the District of Columbia has determined that the Food and Drug Administration (FDA) erred when it classified a combination drug-device product as primarily a drug, thus subjecting its French manufacturer to more burdensome regulatory requirements

U.S. intervenes in False Claims Act suit against biotech company

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 4 2013

The U.S. government has intervened in part of a False Claims Act (FCA) lawsuit against Agave BioSystems, a biotechnology-based small business with

NASDAQ Biotechnology Index surpasses all-time high in 1Q13

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 16 2013

The NASDAQ Biotechnology Index reportedly rose in the first quarter of 2013 (1Q13) above levels last seen during the 2000 genomics bubble peakthe

Science publisher claims submission of prior art to USPTO involves copyright infringement

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 15 2012

A New Jersey-based publishing company has filed copyright infringement lawsuits in federal courts in two states against law firms that submitted citations to or copies of copyrighted articles from scientific journals to the U.S. Patent and Trademark Office (USPTO) with their clients’ patent applications

Court upholds drug profit sharing; pharma co. breached agreement to negotiate deal

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 7 2012

A Delaware court has issued a letter opinion finalizing its 2011 ruling requiring SIGA Technologies Inc. to share profits from its smallpox drug with PharmAthene, Inc. PharmAthene, Inc. v. SIGA Techs, Inc., No. 267-VCP (Del. Ch., decided May 31, 2012

FDA warns competing drug makers over unsubstantiated superiority claims

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 15 2012

The U.S. Food and Drug Administration has sent warning letters to competing drug manufacturers for allegedly promoting their neonatal respiratory distress syndrome treatments using “unsubstantiated superiority claims” that also “omit and minimize important risk information, and present unsubstantiated claims for the drug product”

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