The recommendation is based on the results of an interim review of the study being undertaken by Hunter-Fleming. The Phase IIa multi-centre, double blind placebo controlled, biomarker trial
This first in human study aims to evaluate the safety and tolerability of FIXFc together with its pharmacokinetic profile (primarily its plasma half-life) after a single injection of
The application is based on a positive opinion from the agency’s Scientific Advice Working Party, which agreed to review the application based on the existing results of the
Mr Macdonald most recently served as president and CEO at Nanomix. He also served as president and COO of Nichols Institute Diagnostics, a division of Quest Diagnostics and
Two doses of AZ-104, 2.5 and 5mg, met the primary endpoint of two-hour pain-relief compared to placebo. The company has said that statistically significant improvements in pain response
Under the terms of the agreement, Merck will fund development and commercialization of products that employ MicroDose’s DPI technology for the administration of Merck compounds. MicroDose will receive
The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. The Mindset-01 Phase II, double-blind, placebo-controlled trial is designed to evaluate the safety
The data from the trials support a desirable safety profile at dose levels displaying indications of pharmacologic activity. HBI-3000 is being developed as a potential treatment for both
This intellectual property portfolio is complementary to Amarin’s existing lipid-based development programs including AMR101 and its targeted lipid transport technology. The transaction consideration comprises an upfront fee to
ARRY-797 achieved its primary and secondary endpoints for analgesic efficacy and was well tolerated. Based on these results, Array is moving forward with a second Phase II acute
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