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Results: 1-10 of 355

Lab Trade Association presses FDA on plan to regulate laboratory developed tests
  • Shook Hardy & Bacon LLP
  • USA
  • June 20 2013

The American Clinical Laboratory Association (ACLA) has submitted a citizen petition to the Food and Drug Administration (FDA), asking the agency to


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


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


FDA brings successful enforcement actions against dietary supplement makers
  • Shook Hardy & Bacon LLP
  • USA
  • November 1 2012

The U.S. Food and Drug Administration (FDA) has obtained a permanent injunction against Truman Berst who sells, as Alternative Health & Herbs Remedies, herbs and dietary supplements with disease-treatment claims


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


False-marking plaintiff challenges retroactive application of AIA standing requirement
  • Shook Hardy & Bacon LLP
  • USA
  • November 17 2011

A Benjamin N. Cardozo School of Law-affiliated non-profit legal services organization, known as the Public Patent Foundation, has filed a pleading in its false-marking lawsuit against the company that makes Tylenol products, challenging the constitutionality of a retroactive America Invents Act (AIA) provision that would divest the non-profit of standing


Physician explores future of whole genome sequencing
  • Shook Hardy & Bacon LLP
  • USA
  • June 16 2011

“The iconic $1,000 genome is very close to a realityat least in terms of reagent costs,” writes Eleanor Herriman, director of G2 Research and Analysis with Kennedy Information Inc., in a June 3, 2011, article for BNA’s Life Sciences Law & Industry Report


Viropharma to acquire Swedish pharma in deal worth up to $164.6 million
  • Shook Hardy & Bacon LLP
  • USA
  • November 3 2011

Pennsylvania-based ViroPharma Inc. has reportedly signed a deal to acquire Swedish company DuoCort Pharma AB to expand its orphan disease commercial product pipeline


Campaign seeks to reinforce Hudson Valley as a biotech industry hub
  • Shook Hardy & Bacon LLP
  • USA
  • November 4 2010

Senator Kirsten Gillibrand (D-N.Y.) and business leaders have reportedly unveiled a “NY BioHud Valley” campaign that highlights the state’s Hudson Valley as a “burgeoning epicenter of the biotech industry.”


Agilent Technologies acquires BIOCIUS Life Sciences
  • Shook Hardy & Bacon LLP
  • USA
  • March 10 2011

California-based Agilent Technologies has announced the acquisition of BIOCIUS Life Sciences, a Massachusetts-based company that developed a spectrometry device, enabling "researchers to gain a fuller understanding of a drug's biochemical properties, including potential liabilities in drug interactions