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Intarcia Therapeutics, Inc.

http://www.intarcia.com

Latest From Intarcia Therapeutics, Inc.

US FDA Continues Shutout Of Companies Seeking Drug Rejection Hearings

Intarcia and Lexicon fail to convince FDA's Center for Drug Evaluation and Research to grant hearings after complete response letters. Intarcia contends that kidney injury with its diabetes drug implant is similar to Novo Nordisk’s Wegovy, while Lexicon argues that CDER did not adequately consider a REMS when reviewing its SGLT2 inhibitor.

Complete Response Letters Drug Review

US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain

Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.

Review Pathway Drug Review

Drug Rejection Hearings Are Having A Moment At US FDA

With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.

Complete Response Letters Drug Review

Deal Watch: AzurRx Expands GI Pipeline With Buyout Of Partner First Wave

Stock-and-cash deal valued at $229m brings AzurRx rights to niclosamide in additional indications. Boehringer Ingelheim partners with Twist on therapeutic antibody discovery.

Deal Watch Deals
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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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