SHARE: +/-: 0.40 SEK / Bid: 10.40 SEK / Ask: 10.80 SEK / Price: 10.90 SEK / High: 11.00 SEK / Low: 9.94 SEK / Quantity: 9 790 / Turnover: 102 031 SEK / 2018-12-18 16:20 (CET)
 

News

Improved early detection of breast cancer with MRI compared to mammography in high-risk women

A prospective American study recently published in Clinical Cancer Research shows that bi-annual screening with MRI performs better than mammography for the detection of breast tumors in women who are at high-risk of developing disease based on genetics. This is particularly evident in women who carries the mutation BRCA1 (Guindalini et al., DOI: 10.1158/1078-0432.CCR-18-0200). The recall rate due…
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Spago Nanomedical participates in EU NANO2ALL project

Spago Nanomedical CSO Oskar Axelsson recently participated in “BUILDING RESPONSIVENESS”, a multi-stakeholder dialogue event arranged under the umbrella of the EU funded project NANO2ALL, at the European Commission in Brussels. The workshop aimed at formulating a clear set of practical recommendations for the EU and others involved in the EU-level…
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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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