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Results: 1-10 of 355

Do DNA patents affect genetic sequencing and testing advances?
  • Shook Hardy & Bacon LLP
  • USA
  • November 15 2012

University of Missouri-Kansas City School of Law Professor Christopher Holman writes in the most recent issue of Nature Technology that while DNA sequencing technology has spawned a myriad of patent-related lawsuits, “aggressive patent acquisition and enforcement practices” show no signs of abating and may not necessarily be hindering the development of next-generation DNA sequencing and analysis technologies


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


Stakeholders provide input on FDA review standards for biosimilars
  • Shook Hardy & Bacon LLP
  • USA
  • November 18 2010

The Food and Drug Administration (FDA) recently conducted a two-day hearing to begin the process of determining how it will go about creating review standards for the generic copies (biosimilars) of prescription drugs developed from biological materials (biologics


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


Biotech secures $5.3 million for immunosuppressant drug research
  • Shook Hardy & Bacon LLP
  • USA
  • April 18 2013

San Francisco-based startup, Nurix, Inc., which reportedly develops T-cellspecific immunosuppressants used to treat autoimmune diseases such as


Report highlights growth in oncology R&D among midcap biotechs
  • Shook Hardy & Bacon LLP
  • USA
  • March 21 2013

Business intelligence company GlobalData has released a report on mid-cap biotech companies and concludes that their research and development (R&D


FDA issues guidance on acceptance of foreign clinical studies not conducted under IND
  • Shook Hardy & Bacon LLP
  • USA
  • March 15 2012

The Food and Drug Administration (FDA) has issued guidance titled “Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions.”


FDA reopens comment period for proposed rule on prescription drug ads to assess “distraction study”
  • Shook Hardy & Bacon LLP
  • USA
  • February 2 2012

The Food and Drug Administration (FDA) has reopened the comment period for a proposed rule that would establish standards for direct-to-consumer (DTC) TV and radio advertisements relating to side effects of prescription drugs for humans


New program to provide accelerated “speed-to-market” for medical device entrepreneurs
  • Shook Hardy & Bacon LLP
  • USA
  • March 1 2012

The nonprofit Memphis Bioworks Foundation and Innova, a pre-seed, seed and early-stage investor, have announced a program designed to help entrepreneurs bring medical device products and companies to market


Pharma trade group seeks biologics data exclusivity for international trade
  • Shook Hardy & Bacon LLP
  • USA
  • May 19 2011

PhRMA has reportedly called for the U.S. Trade Representative to go outside provisions in the Korea-U.S. trade deal (KORUS) and press for a 12-year period of exclusivity for biologics in ongoing Trans-Pacific Partnerships (TPP) negotiations