Amarex Client, SOBI, Receives FDA Approval for Kineret for the Treatment of NOMID
Germantown, MD, USA (January 11, 2013) – SOBI, a pharmaceutical developer from Stockholm Sweden, announced the recent FDA approval of their drug, Kineret, for the treatment of NOMID in children. The clinical research for the drug was conducted at the U.S. NIH. Amarex was pleased to have been of assistance to SOBI and the NIH by providing monitoring and auditing services to support GCP compliance of the clinical research.
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications and Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
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