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Results:1-9 of 9

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”.


FDA proposes amendments to sterility testing for biological products
  • Shook Hardy & Bacon LLP
  • USA
  • June 30 2011

The Food and Drug Administration (FDA) has issued a proposed rule amending the sterility test requirements for biological products, including vaccines and stem-cell treatments.


FDA seizes probiotic products marketed as drugs
  • Shook Hardy & Bacon LLP
  • USA
  • June 16 2011

The Food and Drug Administration (FDA) has reportedly seized probiotic products from a Minnesota-based company, alleging that they are being marketed as drugs.


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.


Distributor enters guilty plea for unapproved development and sale of stem cells
  • Shook Hardy & Bacon LLP
  • USA
  • September 1 2011

An Arizona woman who formerly owned a company that sold stem cells to clinics to treat patients with incurable autoimmune diseases, such as amyotrophic lateral sclerosis and multiple sclerosis, has entered a guilty plea to charges that she did so without meeting Food and Drug Administration (FDA) requirements.


News Bytes September 2013
  • Shook Hardy & Bacon LLP
  • USA
  • September 26 2013

The National Institutes of Health (NIH) seeks comments on its draft Genomic Data Sharing (GDS) Policy that outlines the responsibilities of


Takeda gives Affymax $10-million milestone payment in anemia drug enterprise
  • Shook Hardy & Bacon LLP
  • USA
  • August 18 2011

California-based Affymax, Inc. has received a $10-million milestone payment from Japan-based Takeda Pharmaceutical Co. to develop and market peginesatide, an investigational drug for the treatment of anemia in chronic renal-failure patients.


Newlink Genetics sets IPO estimates
  • Shook Hardy & Bacon LLP
  • USA
  • November 3 2011

NewLink Genetics Corp., an Iowa biopharmaceutical company focusing on immunotherapeutic products for improved cancer treatment options, has reportedly established the expected range of its initial public offering (IPO) of 5.5 million shares at $10 to $12 a share.


Data standards partnership launched
  • Shook Hardy & Bacon LLP
  • USA
  • November 1 2012

The U.S. Food and Drug Administration (FDA) has launched a partnership with the Clinical Data Interchange Standards Consortium and Critical Path Institute to develop standardized definitions for individual diseases and the therapeutic approaches to treat them in an effort to transform the massive data streams from drug studies on specific diseases into usable information.