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Albunex wins European panel's nod
Molecular Biosystems has received an approval recommendation fromEurope's Committee for Proprietary Medicinal Products (CPMP) forits Albunex ultrasound contrast agent, which will be marketedin Europe as Infoson. Infoson's application will now go to
Molecular Biosystems has received an approval recommendation fromEurope's Committee for Proprietary Medicinal Products (CPMP) forits Albunex ultrasound contrast agent, which will be marketedin Europe as Infoson. Infoson's application will now go to membercountries of the European Union, whose regulatory agencies generallyfollow CPMP recommendations.
San Diego-based MBI took over regulatory responsibility forInfoson after it reacquired European marketing rights to the agentlate last year from Hafslund Nycomed, which had shepherded Infosonthrough European clinical trials. Nycomed apparently wished tofocus on commercial development of its own ultrasound contrastagents, according to MBI president and COO Bobba Venkatadri.
MBI is looking for another marketing partner to handle Infosonin the regions once covered by Nycomed: Europe, Africa, the MiddleEast, India, and the former Soviet Union. MBI is in discussionswith several firms, including U.S. marketing partner MallinckrodtMedical, and hopes to have a deal sewn up by May, Venkatadri said.
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.
Study Reveals Benefits of Photon-Counting CT for Assessing Acute Pulmonary Embolism
April 23rd 2024In comparison to energy-integrating detector CT for the workup of suspected acute pulmonary embolism, the use of photon-counting detector CT reduced radiation dosing by 48 percent, according to newly published research.
