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News

SpagoPix featured in international media

SpagoPix featured in AuntMinnie, the foremost comprehensive community for radiologists and related professionals in the medical imaging industry. Read more:http://www.auntminnieeurope.com/index.aspx?sec=sup&sub=mri&pag=dis&ItemID=614948    
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FDA votes for further warnings for gadolinium-based contrast agents

In July 2017, the European Medicines Agency (EMA) sent a recommendation to the EU Commission to issue a legally binding decision regarding restrictions on the use of certain gadolinium-based contrast agents for MRI and to completely prohibit the use of others. The decision is based on a scientific review by…
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Production process ready for transfer to GMP manufacture

This spring, Spago Nanomedical initiated an expanded production campaign based on an upscaled manufacturing process optimized with regard to execution, quality and yield. The campaign, which is now completed, has in a cost-efficient way resulted in a sufficient amount of the product candidate SN132D to accommodate the regulatory preclinical studies.…
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Spago granted SME-designation by EMA

As a step in the translation to regulatory development phase with the SpagoPix-project, Spago Nanomedical has applied for and been granted SME-status by the European medical agency (EMA). Holding an SME-status means that the company will get easier access to administrative and regulatory support from the agency, as well as…
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PRAC confirms restrictions on the use of linear gadolinium agents

At a recent meeting, EMA´s committee for pharmacovigilance risk assessment (PRAC) confirmed their position from March 2017 that there are evidence of gadolinium deposition in the brain following use of Gd-contrast agents for MRI. PRAC maintains their recommendation to suspend the commercially available contrast agents Optimark (Guerbet), Omniscan (GE Healthcare) and…
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Promising results in toxicological pilot studies with SpagoPix

Collective data from recently completed toxicity studies show that the product candidate SN132D can be given safely at doses that widely exceeds the expected clinical dose.
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Investigation of gadolinium may lead to increased for MRI contrast agents with manganese

Basically all approved contrast agents for MRI are based on the basic element gadolinium (Gd). The use of the Gd, which is foreign to the body, in some contrast agents been related to serious adverse reactions in groups of patients with impaired renal function. More recently it has also been documented…
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Invitation to presentation of Spago Nanomedical AB’s year-end report for 2016

Spago Nanomedical AB publishes its year-end report for 2016 on February 14.
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Promising results of treatment with internal radionuclide therapy

A paper in New England Journal of Medicine report on promising results from a phase 3 study of the radioactive substance lutetium-177 (Lu177) in patients with advanced cancer in the mid-gut. The study present results from 229 patients with metastatic neuroendocrine tumors treated with standard of care by means of octreotide, or Lu177 in combination with octreotide. Following 20 months the proportion of patients that were…
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Danish study suggests need for improved diagnostics for breast cancer

A paper that was recently published in Annals of Internal Medicine reports a high risk of missing the most aggressive tumors in screening by mammography. The study summarize results from mammography screening of a large number of women in Danmark from 1980 to 2010 and concludes a high rate of overdiagnosis by means of X-ray mammography. The results implicate the need…
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