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Intarcia Therapeutics, Inc.

http://www.intarcia.com

Latest From Intarcia Therapeutics, Inc.

US FDA Chief Scientist Bumpus Will Become Principal Deputy Commissioner

When Janet Woodcock retires early next year, Namandjé Bumpus will take over as No. 2 in command at the FDA. Since joining the agency in 2022 from Johns Hopkins, her profolio has included health disparities, cosmetics, and drug review disputes.

FDA Leadership

US FDA Chief Scientist Bumpus Will Become Principal Deputy Commissioner

When Janet Woodcock retires early next year, Namandjé Bumpus will take over as No. 2 in command at the FDA. Since joining the agency in 2022 from Johns Hopkins, her profolio has included health disparities, cosmetics, and drug review disputes.

FDA Leadership

Pink Sheet Podcast: FTC Orange Book Patent Challenges, Ad/Promo Due Diligence, US FDA Adcomm Decision Appeal

Pink Sheet reporter and editors discuss the FTC’s challenges of Orange Book patents, DTC promotion practices as part of acquisition due diligence, and how Intarcia’s advisory committee decision appeal could play out.

Intellectual Property Advertising, Marketing & Sales

Intarcia Appeals Advisory Committee On Diabetes Drug-Device Combo, Claiming ‘Misrepresentation’

Company contends US FDA gave the committee ‘materially false and misleading information’ about ITCA 650 exenatide implant and did not focus on GLP-1 comparative claims as it seeks a hearing before the commissioner following the panel’s unanimous vote against the application.

Advisory Committees Drug Safety
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Controlled Release
  • Medical Devices
    • Implantable Devices
  • Biotechnology
    • Large Molecule
  • Other Names / Subsidiaries
    • BioMedicines, Inc.
    • PhaseGain Clinical Research, Inc.
    • Phoundry Pharmaceuticals
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