Palatin LeuTech Diagnostic Cost-Effectiveness Analysis Under Way
Executive Summary
Palatin Technologies is conducting a cost-effectiveness analysis to support use of LeuTech to aid in the diagnosis of equivocal appendicitis.
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Palatin/Mallinckrodt Leutech
"Complete review" letter issued by FDA for radiolabeled monoclonal imaging agent, Palatin announces Sept. 28. The letter requests additional manufacturing and process validation data prior to approval. Palatin's contract manufacturer for the biologic is DSM. The BLA for the indication of the diagnosis of equivocal appendicitis was filed Nov. 22, 1999 and recommended by an advisory committee in July (1"The Pink Sheet" July 24, p. 32)
Palatin/Mallinckrodt Leutech
"Complete review" letter issued by FDA for radiolabeled monoclonal imaging agent, Palatin announces Sept. 28. The letter requests additional manufacturing and process validation data prior to approval. Palatin's contract manufacturer for the biologic is DSM. The BLA for the indication of the diagnosis of equivocal appendicitis was filed Nov. 22, 1999 and recommended by an advisory committee in July (1"The Pink Sheet" July 24, p. 32)
LeuTech Studies In Neutropenic Patients Suggested By FDA Committee
Palatin and co-development partner Mallinckrodt should conduct studies with LeuTech to verify efficacy in neutropenic patients and to ensure that the radiolabeled monoclonal antibody imaging agent does not damage white blood cells, FDA's Medical Imaging Drugs Advisory Committee suggested during a July 10 meeting.