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Vaccine developer agrees to settle shareholder litigation

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 11 2014

A putative class action instituted by three shareholders against the nowbankrupt biotechnology company Biovest International, Inc., alleging

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

FDA releases clinical trial action plan

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 11 2014

The U.S. Food and Drug Administration (FDA) has issued a 27-point action plan aimed at improving diversity in clinical trials. While the numbers of

“Purple Book” sets forth approved biologicals, will expand to biosimilars

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • September 11 2014

The U.S. Food and Drug Administration (FDA) has released lists of reference biological products regulated by the Center for Drug Evaluation and

FDA issues guidance on unique medical device ID system

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 21 2014

The U.S. Food and Drug Administration (FDA) has issued guidance to help industry, particularly small businesses, label their medical devices in

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 21 2014

The U.S. Food and Drug Administration (FDA) seeks participation proposals for a pilot program involving tools that manufacturers and the agency can

Guilty plea entered in cancer-drug smuggling operation

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 21 2014

The owner of an Istanbul, Turkey-based pharmaceutical company has pleaded guilty in a Missouri federal court to charges that he shipped illegal

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

23andMe insurer claims no duty to defend company

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 7 2014

The insurance carrier that issued a "ProductsCompleted Operations Liability and Professional Liability Policy for Life Sciences" policy to 23andMe

U.S. senators call on FDA to finalize biosimilars guidance

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 7 2014

Five Republican U.S. senators have written to Health and Human Services (HHS) Secretary Sylvia Burwell to express concerns about the Food and Drug