Intarcia Therapeutics, Inc.
http://www.intarcia.com
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Latest From Intarcia Therapeutics, Inc.
Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
A US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.
Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.
Delivery Device Continues To Be Intarcia’s Downfall Ahead Of FDA Panel On Nonapproval of Implantable GLP-1
CDER reviewers don’t buy that safety concerns with exenatide implant ITCA 650 are in line with the risks labeled for already approved GLP-1 agonists for type 2 diabetes – even other formulations of the same drug – potentially due to unique considerations associated with Intarcia’s delivery method.
The US FDA Committee ‘Hearing’ Is Dead! Long Live The Committee Hearing!
The US FDA is free from the need to reconsider Accelerated Approvals in a formal hearing in front of an advisory committee. But now the agency is now trying that approach to hear an appeal of a rejected application.
Company Information
- Industry
- Biotechnology
- Pharmaceuticals
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Pharmaceuticals
- Specialty Pharmaceuticals
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Drug Delivery
- Controlled Release
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Medical Devices
- Implantable Devices
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Biotechnology
- Large Molecule
- Other Names / Subsidiaries
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- BioMedicines, Inc.
- PhaseGain Clinical Research, Inc.
- Phoundry Pharmaceuticals
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