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news.FDA grants orphan drug status to Marshall Edwards’s melanoma drug
A grant of orphan drug status provides seven years of market exclusivity for the orphan indication after approval by the FDA, as well as tax incentives, study design
A grant of orphan drug status provides seven years of market exclusivity for the orphan indication after approval by the FDA, as well as tax incentives, study design
AcryMed will manufacture for I-Flow a new line of silver transparent wound-site dressings, which I-Flow expects to bring to market in the first half of this year. In
Earl Yager, Chad’s president and CEO, said, “With additional proprietary products in an advanced stage of development and a roadmap of additional product development opportunities based on our
Orphan drug status was granted for the treatment of both anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or
The EOquin registration plan calls for two double blind, placebo-controlled, randomized Phase III clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder
The MAA submission is based upon data from several trials, including the landmark TRITON-TIMI 38 clinical trial, which evaluated the safety and efficacy of prasugrel compared with clopidogrel
The total contract amount is a minimum value as Datatrak will be providing all associated services for this client’s global clinical trials utilizing Datatrak eClinical throughout the life
After IND clearance by the FDA, Hollis-Eden plans to initiate a Phase I/II dose ranging clinical trial of Apoptone in prostate cancer patients during the second quarter of
According to advice from the FDA, Innocoll will conduct two multi-centered Phase III clinical trials in the US to support the planned new drug application (NDA). Innocoll has
The trial has evaluated the potential of cethromycin to cause a prolongation in electrocardiographic QT interval. At the therapeutic and supratherapeutic doses, cethromycin showed no signal of any