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Mallinckrodt files NDA for Optimark
Mallinckrodt has filed a new drug application for its Optimark MRI contrast agent, the St. Louis company announced this month. Optimark (Gd-DTPA-BMEA) is an extracellular agent designed for visualizing lesions in the brain, spine, and liver. Mallinckrodt
Mallinckrodt has filed a new drug application for its Optimark MRI contrast agent, the St. Louis company announced this month. Optimark (Gd-DTPA-BMEA) is an extracellular agent designed for visualizing lesions in the brain, spine, and liver. Mallinckrodt developed the product internally.
Optimark's approval will be an important milestone for Mallinckrodt, rounding out its product portfolio and making it easier for the company to win single-source supply deals with large purchasers. Mallinckrodt's product line already includes agents for x-ray, ultrasound, and CT, as well as organ-specific MRI studies, but the firm does not offer contrast media for MRI scans in the central nervous system, which composes the lion's share of MRI studies. Optimark will compete with general-purpose MRI agents such as Schering's Magnevist, Bracco's ProHance, and Nycomed Amersham's Omniscan.
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.
