BioLawGics

A blog by the Life Sciences team at Dechert LLP devoted to exploring the legal aspects of bringing biological medicines to market.

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Archives by Category

  • Antitrust
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Archives by Tag

  • 262(k) Teva Neutroval Amgen filgrastim GCSF
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  • ACA
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  • Amgen Teva filgrastim
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  • Biologics biosimilar sales
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  • Fabrazyme Genzyme Shelbyzyme non-enablement
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  • FDA Guidance
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  • India Guidelines
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  • Mayo v. Prometheus isolated DNA
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  • Myriad Prometheus
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  • Noerr-Pennington
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  • Nuepogen
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  • Off-label promotion
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  • Phrma Bio
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  • Section 101
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  • Supreme Court
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  • Teva
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  • utility
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  • Venture Capital

Topics

  • Antitrust
  • Biosimilars
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  • FDA Approval
  • Patent Law
  • Archives

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Topics for Us to Address

Please email us your questions regarding the law of biologics.

Recent Updates

  • Second Circuit Court of Appeals Issues Blow Against Off-Label Promotion Enforcement
  • Supreme Court to hear Myriad
  • BLAs vs. Biosimilars
  • Teva's Tbo-Filgrastim Paving the Way for Biosimilars?
  • $50 Million Jury Award Against Genzyme for Infringing Patent Covering Fabrazyme®

Resources

  • List of BLA Approvals (through January 13, 2011)
  • Biosimilars Act 42 USC 262
  • FDA Draft Biosimilar Guidance -- Scientific Considerations
  • FDA Draft Biosimilar Guidance -- Quality Considerations
  • FDA Biosimilars Questions and Answers

Links

  • European Medicines Agency
  • European Patent Office
  • U.S. Federal Trade Commission
  • U.S. Food & Drug Administration
  • U.S. Patent & Trademark Office

Blogs

  • FDA Law Blog
  • Orange Book Blog
  • Patently O

Other Dechert Blogs

  • Crunched Credit
  • Drug and Device Law

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