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Results: 11-20 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

Hopen Life Science Ventures’ second fund reaches $25 million

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 18 2011

Hopen Life Science Ventures, based in Grand Rapids, Michigan, has announced an initial close of $25 million for its second fund, which will remain open to new limited partners to raise a total of $50 million by January 2012

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

Albuquerque biotech startup announces $13 million in funding for bacteria

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

nanoMR Inc., an early-stage life sciences company based in Albuquerque, New Mexico, has announced that it has raised $13 million in Series B venture capital to support commercializing a device that rapidly diagnoses bacteria in blood

Public-private partnership in Baltimore to develop stem cell therapies

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 5 2011

The University of Maryland, Baltimore, (UMB) and Paragon Bioservices Inc., a contract research and manufacturing organization with headquarters at UMB’s BioPark, have announced a public-private partnership to develop and manufacture stem cell therapies

NASDAQ Biotechnology Index surpasses all-time high in 1Q13

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • May 16 2013

The NASDAQ Biotechnology Index reportedly rose in the first quarter of 2013 (1Q13) above levels last seen during the 2000 genomics bubble peakthe

FDA warns radiopharmaceutical maker over manufacturing practices

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

The Food and Drug Administration (FDA) has issued a warning letter to International Isotopes, Inc., indicating that an inspection revealed “significant violations of Current Good Manufacturing Practices (CGMP) for finished pharmaceuticals.”

Biopharmaceutical companies have 215 heart diseasestroke drugs in R&D pipeline

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

According to a new Pharmaceutical Research and Manufacturers of America (PhRMA) report, U.S. biopharmaceutical companies have 215 medicines under

New program to provide accelerated “speed-to-market” for medical device entrepreneurs

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

The nonprofit Memphis Bioworks Foundation and Innova, a pre-seed, seed and early-stage investor, have announced a program designed to help entrepreneurs bring medical device products and companies to market

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