18:23 , Oct 6, 2017 |  BC Week In Review  |  Clinical News

Blue Earth reports Phase III data of imaging agent for prostate cancer treatment planning

Blue Earth Diagnostics Ltd. (London, U.K.) said that based on "successful results" of a pre-planned interim analysis, it halted enrollment in the Phase III Falcon trial of imaging agent Axumin [18F]-fluciclovine in patients with biochemical...
00:57 , Mar 29, 2017 |  BC Week In Review  |  Clinical News

Axumin regulatory update

EMA’s CHMP recommended approval of an MAA from Blue Earth for Axumin [18F]-fluciclovine as a diagnostic PET imaging agent in men with suspected prostate cancer recurrence based on elevated levels of prostate-specific antigen (KLK3; PSA)...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Shedding red

Steve Edelson, Senior Editor   Brexit nearly wiped out what looked to be a rebound quarter for biotech. Only two market cap segments finished in positive territory, and smaller companies continued to get pounded. Big caps...
07:00 , Jun 13, 2016 |  BC Week In Review  |  Company News

Blue Earth Diagnostics, Siemens sales and marketing update

Blue Earth and PETNET Solutions Inc. launched Axumin [18F]-fluciclovine injection in the U.S. as a diagnostic PET imaging agent in men with suspected prostate cancer recurrence based on elevated levels of prostate-specific antigen...
07:00 , Jun 6, 2016 |  BC Week In Review  |  Clinical News

Axumin [18F]-fluciclovine regulatory update

FDA approved an NDA from Blue Earth for Axumin [18F]-fluciclovine as a diagnostic PET imaging agent in men with suspected prostate cancer recurrence based on elevated levels of prostate-specific antigen ( KLK3; PSA) following...
07:00 , Apr 11, 2016 |  BC Week In Review  |  Clinical News

[18F]-fluciclovine: Phase III started

Blue Earth began the open-label, U.K. Phase III FALCON trial to evaluate [18F]-fluciclovine in 180 patients who underwent radical curative treatment and have been diagnosed with biochemically recurrent prostate cancer. An NDA is under Priority...
08:00 , Dec 21, 2015 |  BC Week In Review  |  Clinical News

[18F]-fluciclovine regulatory update

FDA accepted and granted Priority Review to an NDA from Blue Earth for [18F]-fluciclovine PET imaging agent to detect and localize recurrent prostate cancer lesions. The company declined to disclose the PDUFA date. GE...
07:00 , Mar 17, 2014 |  BC Week In Review  |  Company News

Blue Earth Diagnostics, General Electric deal

General Electric's GE Healthcare Ltd. business granted newco Blue Earth exclusive rights outside of China and undisclosed Asian territories to develop and commercialize PET imaging agent [18F]-fluciclovine. The imaging agent has completed Phase II...