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Results: 1-10 of 354

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”

Federal Circuit’s patent infringement ruling conflicts with USPTO re-examination on validity

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 1 2012

The Federal Circuit Court of Appeals has denied a request for an en banc rehearing by a medical-device patent holder which argued that the U.S. Patent and Trademark Office’s (USPTO’s) Board of Patent Appeals had effectively nullified a previous Federal Circuit decision on the validity of its patent

Campaign seeks to reinforce Hudson Valley as a biotech industry hub

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 4 2010

Senator Kirsten Gillibrand (D-N.Y.) and business leaders have reportedly unveiled a “NY BioHud Valley” campaign that highlights the state’s Hudson Valley as a “burgeoning epicenter of the biotech industry.”

University of Massachusetts, UK collaborate on stem cell project

  • Shook Hardy & Bacon LLP
  • -
  • United Kingdom, USA
  • -
  • March 24 2011

The University of Massachusetts Human Stem Cell Bank and Registry and the United Kingdom Stem Cell Bank have reportedly agreed to collaborate on best practices for stem cell banking, including delivery of stem cell lines for clinical use, and may explore funding opportunities for joint research projects

Research institution creates regional biomedical hub in Florida

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 10 2011

The Jackson Laboratory, a Maine-based biomedical research institution, has announced a partnership to develop "genetics-based" treatments for heart disease, Alzheimer's disease and diabetes at a new 120,000-square-foot research facility in Sarasota County, Florida

Biotech company settles claims that counsel divulged confidential information

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 21 2011

A federal court in California has dismissed with prejudice claims that a biotech company filed against its former counsel alleging that the law firm had provided confidential information about the company's patent applications to another client

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

Presidential bioethics panel to examine genome privacy

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 19 2012

The Presidential Commission for the Study of Bioethical Issues is seeking public comments “on the ethical issues raised by the ready availability of large-scale human genome sequence data, with regard to privacy and data access and the balancing of individual and societal interests.”

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

News bytes 10 January 2013

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 10 2013

The U.S. Patent and Trademark Office (USPTO) schedules an Additive Manufacturing Partnership Meeting on January 23, 2013, at its Alexandria, Virginia