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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

U.S. intervenes in False Claims Act suit against biotech company

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 4 2013

The U.S. government has intervened in part of a False Claims Act (FCA) lawsuit against Agave BioSystems, a biotechnology-based small business with

Congress takes FDA to task for inaction over fungal meningitis outbreak

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

A House Energy and Commerce Subcommittee questioned Food and Drug Administration (FDA) Commissioner Margaret Hamburg on April 16, 2013, about the

Congressional staff report shows gaps in compounding drug regulation

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

In the wake of a hepatitis outbreak linked to a New England compounding pharmacy, Representative Edward Markey (D-Mass.) has released a staff report exploring “the nature of regulatory oversight and gaps in legal authority that led to one of the worst public health tragedies in recent U.S. history.”

FDA issues draft guidance on pharmaceutical co-crystals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The Food and Drug Administration (FDA) has announced the availability of industry draft guidance titled “Regulatory Classification of Co-Crystals.”

Biotech secures $7.2 million for cancer research

  • Shook Hardy & Bacon LLP
  • -
  • Singapore, USA
  • -
  • March 21 2013

Clearbridge BioMedics, a Singapore-based company that develops medical devices for cancer research and diagnostics, has announced a new series B

Neumedicines receives $8.3 million from BARDA for radiation sickness drug

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

Pasadena-based Neumedicines Inc. has reportedly received $8.3 million from the Biomedical Advanced Research & Development Authority (BARDA) of the U

News Bytes - May 16, 2013

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

The National Institutes of Health (NIH) Office of Biotechnology Activities proposes revising the "NIH Guidelines for Research Involving Recombinant

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

FDA targets “high-risk” compounding pharmacies for inspection

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • March 7 2013

The Food and Drug Administration (FDA) has reportedly begun focusing its investigative efforts on compounding pharmacies at "high risk" for