Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
B. Braun Melsungen, The Trendlines Group and ApiFix jointly announced B. Braun's lead position in ApiFix's B round financing; ApiFix is a Trendlines portfolio company. B. Braun's Aesculap division invested $2.8 million in the $5 million round which is to close by end of 2016.
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