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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

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”

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

Federal Circuit says certain human genes may be patented

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 4 2011

In a ruling likely to be appealed to the U.S. Supreme Court, a divided Federal Circuit Court of Appeals panel has determined that genetic discoveries may, to a certain extent, be patented

Pharmacy and hospital interests present comments on proposed compounding bill

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 20 2013

Proposed legislation (S. 959) that would give the U.S. Food and Drug Administration (FDA) the authority to oversee compounding pharmacies that ship

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

Advocacy coalition agrees to drop nanotechnology lawsuit against FDA

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • June 7 2012

A coalition of advocacy organizations has reportedly agreed to dismiss as moot its lawsuit seeking an order requiring the Food and Drug Administration (FDA) to respond to its 2006 petition asking the agency to regulate products containing nanomaterials

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

$10-million prize offered for accurate human genome sequencing

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 3 2011

Craig Venter, creator of rapid DNA sequencing technology, has reportedly told Scientific American that he and two partners will award $10 million to the first team that can meet “medical grade” accuracy in human genome sequencing, a factor that has been lacking since the technology was first developed in 2000

Large pharmaceutical companies look to buy niche Indian biotech firms

  • Shook Hardy & Bacon LLP
  • -
  • India, USA
  • -
  • January 13 2011

Major pharmaceutical companies are reportedly buying niche biotech firms in India to take advantage of emerging opportunities involving biosimilar drugs, which are expected to have a market share of approximately $78 billion by 2013