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Blue Earth Diagnostics Ltd.
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Bracco Imaging S.p.A. has signed a definitive agreement to acquire Blue Earth Diagnostics, a molecular imaging company based in Oxford, U.K. Subject to customary closing conditions, completion of the transaction is expected in the third quarter of this calendar year.
Blue Earth Diagnostics announced expanded access to the Axumin (fluciclovine (18F)) imaging agent in Europe. The first commercial production of Axumin in Belgium occurred recently, with the first Belgian patients being dosed. This follows the first administration of Axumin in Luxembourg earlier this year. Axumin is the first and only positron emission tomography (PET) imaging agent approved in the European Union for use in men with suspected recurrent prostate cancer. Axumin is commercially available in Belgium, Luxembourg, Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria, with further European countries set to follow soon.
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in radiopharmaceuticals and radiopharmaceutical technologies. Under the terms of the agreement, Blue Earth Diagnostics has acquired the exclusive worldwide rights to a broad family of prostate specific membrane antigen (PSMA)-targeted radiohybrid (“rh”) agents for cancer imaging, together with an exclusive option to explore therapeutic applications.
Blue Earth Diagnostics announced that Axumin (fluciclovine F 18) injection has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Prostate Cancer (Version 1.2018). These updated NCCN Guidelines state that F-18 fluciclovine positron emission tomography/computed tomography (PET/CT) or PET/magnetic resonance imaging (MRI) should be considered in the clinical workup of patients with recurrence or progression of their prostate cancer. This recommendation is based on uniform NCCN consensus that the intervention is appropriate.
Blue Earth Diagnostics announced that the Trial Steering Committee recommended further recruitment be stopped in the FALCON clinical study of fluciclovine (18F) PET/CT imaging, based on successful results of a pre-planned interim analysis. The FALCON trial, announced in March 2016, is a U.K.-based, open-label study (NCT02578940) to evaluate the clinical impact of fluciclovine (18F) positron emission tomography/computed tomography (PET/CT) imaging on patient management decisions in men with biochemically recurrent prostate cancer.
Blue Earth Diagnostics and Siemens’ PETNET Solutions announced that an increasing number of radiopharmacies will offer Blue Earth Diagnostics’ Axumin (fluciclovine F-18) positron emission tomography (PET) imaging agent through PETNET’s national network.
Blue Earth Diagnostics Ltd. announced the peer-reviewed publication of results from a Phase 3 clinical trial of Axumin (fluciclovine F 18) injection. Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate-specific antigen (PSA) following prior treatment. Results of the multi-center study, conducted in Norway, Italy and the United States, demonstrated a 68 percent overall detection rate (DR) for Axumin, with the ability to detect local, as well as distant, prostate cancer recurrence across a wide range of PSA values. Axumin was well-tolerated in the study.
September 7, 2016 — Blue Earth Diagnostics announced that the first post-U.S. Food and Drug Administration (FDA) ...
June 7, 2016 — Blue Earth Diagnostics Ltd. and Siemens’ PETNET Solutions Inc. announced the commercial availability of ...
Blue Earth Diagnostics, a molecular imaging diagnostics company, announced it has established operations in the United States in Burlington, Mass.