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Results: 1-10 of 355

IOM publishes report on the effects of falsified and substandard medicines
  • Shook Hardy & Bacon LLP
  • Global, USA
  • February 21 2013

At the request of the U.S. Food and Drug Administration (FDA), national think tank the Institute of Medicine (IOM) has published a report that


FDA considers changes to generic drug labeling rules
  • Shook Hardy & Bacon LLP
  • USA
  • February 21 2013

A footnote in an amicus brief filed by the U.S. Department of Justice (DOJ) in a case involving whether a design-defect claim asserted against a


U.S. Supreme Court to consider just one question in Myriad Genetics
  • Shook Hardy & Bacon LLP
  • USA
  • December 6 2012

The U.S. Supreme Court has agreed to review a Federal Circuit Court of Appeals ruling on the patentability of human genes and limited its grant of certiorari to the question “Are human genes patentable?”


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

The Food and Drug Administration makes available additional draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support abbreviated new drug applications


New biotech jobs in Massachusetts outpace hiring in other industries
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

According to a new Massachusetts Biotechnology Council report, while hiring in the biotech industry has not fully recovered from the recession, the industry is adding jobs faster in Massachusetts than the state’s economy as a whole, and the state has added more jobs in biotechnology research than any other state between 2007 and 2011


Study shows rise in biotech patent litigation
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

PricewaterhouseCoopers LLP has released its “2012 Patent Litigation Study,” which shows that the 4,105 patent lawsuits filed in 2011 marked a high point and a 22-percent increase from the previous year


Comments sought on guidelines for nanotoxicology research papers
  • Shook Hardy & Bacon LLP
  • USA
  • September 20 2012

Nature Nanotechnology editors have initiated an effort to develop guidelines that would apply to researchers submitting papers on the toxicity of various nanomaterials


News bytes
  • Shook Hardy & Bacon LLP
  • USA
  • December 6 2012

Heads of the U.S. Patent and Trademark Office (USPTO), European Patent Office and Japan Patent Officecollectively known as the Trilateral Offices confirm their commitment to eliminating unnecessary duplication of work, enhancing patent examination and quality, and working to ensure that stable patent rights can be granted smoothly and easily worldwide


Bioethics commission issues report on genome sequencing and privacy
  • Shook Hardy & Bacon LLP
  • USA
  • October 18 2012

The Presidential Commission for the Study of Bioethical Issues has issued a report “Privacy and Progress in Whole Genome Sequencing,” one in a series that the commission will produce as it identifies and promotes “policies and practices to ensure that scientific research, health care delivery, and technological innovation are conducted by the U.S. in a socially and ethically responsible manner.”


Indian biotech association signs MOU with U.S.-based association
  • Shook Hardy & Bacon LLP
  • India, USA
  • October 18 2012

The Association of Biotechnology Led Enterprises (ABLE), representing biotechnology interests in India, has reportedly signed a memorandum of understanding (MOU) with the Washington Biotechnology and Biomedical Association (WBBA), Washington state’s life-sciences trade association