Ergomed plc
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Latest From Ergomed plc
Multiple Stargardt Contenders Progress In Japan Despite Small Market
With no approved therapies globally for Stargardt's, competition in the indication is increasing in Japan, where Kubota Vision is seeking for conditional approval for emixustat, while Belite Bio’s contender tinlarebant has received Sakigake designation as a local Phase III program continues.
Oh NOOH! Vanda’s Multi-Front Battle With US FDA Extends To Insomnia Drug Hetlioz
The notice of opportunity for hearing on the US FDA’s proposal not to approve an insomnia sNDA for Vanda’s Hetlioz opens another front in the company’s aggressive campaign against complete response letters and generic competition to the sleep disorder drug.
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.
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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