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news.OSI reports positive diabetes treatment study results
The company reported that exposure to its drug and metformin did not change to a clinically relevant extent when they were co-administered, compared with each therapy alone. “This
The company reported that exposure to its drug and metformin did not change to a clinically relevant extent when they were co-administered, compared with each therapy alone. “This
This license includes access to Idea's Transfersome technology platform that delivers drugs locally to targeted areas. In May 2007, Idea AG submitted a marketing authorization application in Europe
The randomized Phase II trial for the Stimuvax MUC-1 vaccine was conducted in non-small cell lung cancer (NSCLC) patients. Merck says the results suggest that Stimuvax combined with
Changchun Xinan (CCXA) is a privately owned business primarily serving the rural healthcare market with more than 100 plant-based pharmaceutical products in its portfolio. American Oriental Bioengineering (AOBO)
The decision was based in part on the agency’s guidance that a primary endpoint analysis of less than the initially-projected 320 eligible patients could be acceptable for new
The Phase I study will be a double-blind, placebo controlled, randomized, escalating intravenous single dose safety and tolerability study in healthy volunteers and takes place in the US.
Through the FDA’s special protocol assessment (SPA) process, Kosan and the FDA have reached agreement on overall protocol design, primary efficacy endpoints and data analysis as well as
In a response to Encysive’s request for a formal dispute resolution on its new drug application for Thelin, the FDA’s reviewer agreed with the decision of the Division
The Phase III trial of 956 patients is designed to compare the overall survival of patients taking Sutent (sunitinib) in combination with Tarceva (erlotinib) with those taking erlotinib
Data from the Phase III trial showed that at 12 months AGI-1067 delivered only a minor reduction in glycated hemoglobin A1c, a commonly used measure of glycemic control.