Ergomed plc
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Latest From Ergomed plc
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.
Intarcia’s Fight To Win ITCA 650 Approval: Former Employees Object To FDA AdComm Presentations
In another case of criticism after an adcomm, three former Intarcia employees, including the key developer of the ITCA 650 device, contend agency made ‘erroneous statements’ about performance and manufacturing to the advisory committee that voted unanimously against the type 2 diabetes treatment.
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.
Company Information
- Industry
- Contract Research Organization-CRO
- Pharmaceuticals
- Services
-
Biotechnology
- Large Molecule
- Other Names / Subsidiaries
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- Ashfield Pharmacovigilance
- Ergomed Group
- Haemostatix Limited
- PSR Group BV
- MS Clinical Services
- MedSource Technologies Inc.
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