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Nycomed files MAA for Diatide's AcuTect
Peptide imaging agent developer Diatide of Londonderry, NH, reported last month that its marketing partner, Nycomed Amersham, has submitted Diatide's AcuTect product for regulatory review by European authorities. Nycomed, of Buckinghamshire, U.K.,
Peptide imaging agent developer Diatide of Londonderry, NH, reported last month that its marketing partner, Nycomed Amersham, has submitted Diatide's AcuTect product for regulatory review by European authorities. Nycomed, of Buckinghamshire, U.K., submitted a marketing approval application (MAA) for the product to the European Medicines Evaluation Agency. Nycomed has informed Diatide that it hopes to gain approval for AcuTect in the next 12 months.
AcuTect, formerly known as P280, is a technetium-labeled product for the detection and localization of acute venous thrombosis. Diatide filed a new drug application (NDA) for AcuTect with the Food and Drug Administration in September. The NDA was granted a priority rating, meaning that the agency intends to complete its review in six months.
New Study Assesses Long-Term Outcomes of PSMA PET Use in PCa Recurrence Cases
October 24th 2024For patients with biochemical recurrence of prostate cancer, PSMA PET imaging may facilitate a 12.8 percent lower incidence of prostate cancer mortality in contrast to the combination of CT and bone scan, according to long-term outcome estimates from a new decision-analytic modeling study.
Can Diffusion MRI Predict Patient Response to Neoadjuvant Chemotherapy for Breast Cancer?
October 23rd 2024A model emphasizing time-dependent diffusion MRI was 15 percent more effective than apparent diffusion coefficient (ADC) measurements at predicting pathologic complete response to neoadjuvant chemotherapy for women with breast cancer, according to new research.
