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Sonus files for EU approval of EchoGen
Sonus Pharmaceuticals announced that the European Medicines EvaluationAgency (EMEA) has accepted the company's marketing authorizationapplication (MAA) for its EchoGen ultrasound contrast agent forcardiology and radiology indications. The application, if
Sonus Pharmaceuticals announced that the European Medicines EvaluationAgency (EMEA) has accepted the company's marketing authorizationapplication (MAA) for its EchoGen ultrasound contrast agent forcardiology and radiology indications. The application, if approved,would enable Sonus to market EchoGen in all 15 nations of theEuropean Union, according to the company.
The Bothell, WA-based company submitted its application underthe new centralized application procedure, whereby a generallybinding approval, valid for all EU nations, may be obtained bya single application. Sonus made the announcement at the Hambrecht& Quist Healthcare Conference in San Francisco this month.
The filing generated a $1 million milestone payment from marketingpartner Abbott Laboratories of Abbott Park, IL (SCAN 10/23/96).Sonus filed a new drug application for EchoGen with the Food andDrug Administration in September. Sonus is set to receive another$4.4 million in milestone payments this year from Abbott afterbeginning phase III trials for use of EchoGen in myocardial perfusionstudies.
In other Sonus news, the company announced that researchersfrom Albany (NY) Medical College showed the first publicly presentedimages of EchoGen-enhanced prostate studies at the RadiologicalSociety of North America meeting in December.
FDA Approves Fluorescence Imaging System for Detecting Residual Breast Cancer
April 18th 2024The combination of the optical imaging agent Lumisight and the fluorescence imaging device Lumicell Direct Visualization System, collectively known as LumiSystem, reportedly offers 84 percent accuracy with real-time detection of residual breast cancer after lumpectomy procedures.
Study of Ofatumumab for Multiple Sclerosis Shows 'Profoundly Suppressed MRI Lesion Activity'
April 17th 2024The use of continuous ofatumumab in patients within three years of a relapsing multiple sclerosis diagnosis led to substantial reductions in associated lesions on brain MRI scans, according to research recently presented at the American Academy of Neurology (AAN) conference.
Could a Deep Learning Model for Mammography Improve Prediction of DCIS and Invasive Breast Cancer?
April 15th 2024Artificial intelligence (AI) assessment of mammography images may significantly enhance the prediction of invasive breast cancer and ductal carcinoma in situ (DCIS) in women with breast cancer, according to new research presented at the Society for Breast Imaging (SBI) conference.
