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Results: 11-20 of 355

News Bytes - February 8, 2013
  • Shook Hardy & Bacon LLP
  • USA
  • February 8 2013

The Food and Drug Administration issues guidance titled "Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and


FDA targets “high-risk” compounding pharmacies for inspection
  • Shook Hardy & Bacon LLP
  • USA
  • March 7 2013

The Food and Drug Administration (FDA) has reportedly begun focusing its investigative efforts on compounding pharmacies at "high risk" for


News bytes - March 7, 2013
  • Shook Hardy & Bacon LLP
  • USA
  • March 7 2013

The U.S. Patent and Trademark Office (USPTO) seeks public comments by May 3, 2013, on "information requirements related to civil actions and claims


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


Biotech set to raise $86 million in IPO to support cancer and IEM products
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

Agios Pharmaceuticals, Inc. has filed a registration statement with the U.S. Securities and Exchange Commission indicating its intent to raise up to


Lab Trade Association presses FDA on plan to regulate laboratory developed tests
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

The American Clinical Laboratory Association (ACLA) has submitted a citizen petition to the Food and Drug Administration (FDA), asking the agency to


Neumedicines receives $8.3 million from BARDA for radiation sickness drug
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

Pasadena-based Neumedicines Inc. has reportedly received $8.3 million from the Biomedical Advanced Research & Development Authority (BARDA) of the U


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


Biopharmaceutical companies have 215 heart diseasestroke drugs in R&D pipeline
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

According to a new Pharmaceutical Research and Manufacturers of America (PhRMA) report, U.S. biopharmaceutical companies have 215 medicines under


FDA seeks comments on de-identified and masked data
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

The U.S. Food and Drug Administration (FDA) has issued a notice seeking comments on "the proposed availability of de-identified and masked data