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Results: 1-10 of 354

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

Venture capitalists are returning to life-sciences investing

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2012

Reuters reports that a number of global venture firms have renewed their interest in the life sciences and health-care sectors, motivated by big acquisitions, U.S. laws speeding up certain drug approval processes and new products that have broadened the life-sciences definition

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

News bytes

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2012

U.S. Health and Human Services Secretary Kathleen Sebelius delegates authority to the Food and Drug Administration (FDA) to determine whether clinical trial information was not submitted to the Clinical Trial Registry and Results Data Bank as required by law or “was submitted but is false or misleading in any particular.”

Fractured Myriad Genetics ruling follows SCOTUS remand

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 30 2012

Ruling that one plaintiff had standing to seek a declaratory judgment as to the patent eligibility of certain genetic discoveries, the Federal Circuit Court of Appeals has once again reversed in part and affirmed in part a lower court’s determination that isolated DNA molecules and methods of comparing molecules to determine whether a patient’s genes have mutations that could cause breast and ovarian cancer were not patent eligible

Biopharma co. seeks $90 million for tainted raw material from China

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 3 2012

A biopharmaceutical company has sued companies in its supply chain, alleging they were negligent or vicariously liable for obtaining from China a raw material, contaminated with beef broth and avian products, for use in the creation of a bacterial master cell bank for the production of a biologic drug that will be used in patients with acute spinal cord injury

FDA brings successful enforcement actions against dietary supplement makers

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

The U.S. Food and Drug Administration (FDA) has obtained a permanent injunction against Truman Berst who sells, as Alternative Health & Herbs Remedies, herbs and dietary supplements with disease-treatment claims

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

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”

Grifols acquires 51 percent stake in Araclon Biotech

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 29 2012

Grifols, a Spanish plasma-product manufacturer specializing in the hospitalpharmaceutical sector, has announced that it has acquired 51 percent of the equity of Zaragoza-based Araclon Biotech, a company spun off from the University of Zaragoza in 2004 to develop therapies and diagnostics for Alzheimer’s disease