Siemens Submits Exploratory Investigational New Drug Application to FDA for New Imaging Agent | Siemens Healthcare
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Healthcare Company News Siemens Healthcare Siemens Submits Exploratory Investigational New Drug Application to FDA for New Imaging Agent

Siemens Submits Exploratory Investigational New Drug Application to FDA for New Imaging Agent

Company News - Siemens Healthcare
Siemens Healthcare has filed an exploratory Investigational New Drug (eIND) application with the FDA for a for a new imaging agent Siemens Healthcare has filed an exploratory Investigational New Drug (eIND) application with the FDA for a for a new imaging agent [18F]-SMIBR-W372, to image Amyloid Plaque associated with Alzheimer's Disease. The latest result of Siemens broad PET biomarker research program, this new plaque imaging agent, when imaged using Positron Emission Tomography, has been designed to seek out amyloid plaques in the living human brain. Together with other agents developed in the program, [18F]-SMIBR-W372 may assist Siemens in achieving its goal of diagnosing Alzheimer’s disease in its earliest stages.

Through Siemens Molecular Imaging Biomarker Research Center in Culver City, Calif., the company is actively investigating tools that may support a more personalized approach to medicine. Imaging biomarkers not only enable early diagnosis, but also allow the measurement of how well certain therapies, such as prescription drugs, chemotherapy and radiation therapy, are working by measuring the impact of treatments on the disease indicators. This may aid the development of new therapies, and enable clinicians to noninvasively assess therapeutic responses and quickly adjust therapeutic approaches to arrive at optimum outcomes.

The exploratory eIND application with the FDA has been filed under Siemens Medical Solutions USA, Inc.

The Siemens Healthcare Sector is one of the world’s largest suppliers to the healthcare industry. The company is a renowned medical solutions provider with core competence and innovative strength in diagnostic and therapeutic technologies as well as in knowledge engineering, including information technology and system integration. With its laboratory diagnostics acquisitions, Siemens Healthcare is the first integrated healthcare company, bringing together imaging and lab diagnostics, therapy, and healthcare information technology solutions, supplemented by consulting and support services. Siemens Healthcare delivers solutions across the entire continuum of care – from prevention and early detection, to diagnosis, therapy and care. Additionally, Siemens Healthcare is the global market leader in innovative hearing instruments. The company employs around 49,000 people worldwide and operates in 130 countries. In the fiscal year 2008 (Sept. 30), Siemens Healthcare reported sales of €11.2 billion, orders of €11.8 billion, and Sector profit of €1.2 billion. Further information can be found by visiting http://www.siemens.com/healthcare.

Source: Siemens Healthcare