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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

Takeda acquires access to Envoy’s CNS drug pipeline and bacTRAP technology

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 15 2012

Takeda America Holdings, Inc. has reportedly acquired Envoy Therapeutics, Inc. in a deal worth $140 million, including an up-front payment and progressdependent milestone payments

Court dismisses French company from suit seeking correction of patent inventorship

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 7 2011

A federal court in the District of Columbia has dismissed patent-related litigation against a French drug company for lack of personal jurisdiction

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

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.”

FDA challenges classification of stem cell-based bone regeneration product

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

The Food and Drug Administration (FDA) has warned Parcell Laboratories that it mischaracterized its stem cell-based bone regeneration product as a human cell, tissue and cellular or tissue-based product, when the product is actually a drug or a biologic and must conform to applicable regulations

Series B funding round brings $12 million to expand clinical diagnostics products

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 15 2012

Advanced Cell Dynamics, Inc. has reportedly completed a $12-million Series B equity financing round that will support the commercial expansion of the company’s RNAscope-based products and services

FDA issues guidance on acceptance of foreign clinical studies not conducted under IND

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 15 2012

The Food and Drug Administration (FDA) has issued guidance titled “Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions.”

FTC reports “pay-for-delay” deal trend continuing

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

The Federal Trade Commission (FTC) has found that the ongoing trend of drug companies settling claims filed by rival generic manufacturers with “pay-for-delay” deals is proceeding unabated

Dialysis equipment maker sues component part supplier for indemnification

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 17 2011

A company that makes dialysis equipment for use in clinics and by patients in their homes has filed a complaint in federal court against a company that supplied a component part which allegedly contained a defect that led to a recall and caused injuries and at least one death