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Results: 11-20 of 354

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

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FDA issues draft guidance on pharmaceutical co-crystals

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • December 15 2011

The Food and Drug Administration (FDA) has announced the availability of industry draft guidance titled “Regulatory Classification of Co-Crystals.”

News bytes 10 January 2013

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 10 2013

The U.S. Patent and Trademark Office (USPTO) schedules an Additive Manufacturing Partnership Meeting on January 23, 2013, at its Alexandria, Virginia

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

Tetragenetics Inc. receives $826 million grant for malaria vaccine

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 18 2013

Tetragenetics Inc. has received an $826-million Phase 2 grant as well as new partnerships with two drug companies, according to a news source. The

Court upholds drug profit sharing; pharma co. breached agreement to negotiate deal

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

A Delaware court has issued a letter opinion finalizing its 2011 ruling requiring SIGA Technologies Inc. to share profits from its smallpox drug with PharmAthene, Inc. PharmAthene, Inc. v. SIGA Techs, Inc., No. 267-VCP (Del. Ch., decided May 31, 2012

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.”

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