Under the contract Covalent will support Emergent BioSolutions’ development program by providing project management, study site management, field operations, data management, biostatistical services, and medical writing services. The
Based on the positive results of the trial, the company now plans to move forward with a pivotal phase III clinical development program for MC-1. In the trial
The testing will be conducted to determine whether CEL-1000 could be used as a potential treatment and/or preventive agent against this virus. CEL-1000 has previously been shown to
The results from the ongoing patient study in the UK have demonstrated that Reolysin was well-tolerated by patients and there was evidence of virus replication within several types
The mouse models have innovative modifications in certain key genes which code for proteins or enzymes known as kinases. Protein kinases have profound effects on the cells of
The phase Ib clinical trial follows previously announced preclinical data presented at a recent conference of the American Association for Cancer Research which showed that the combination of
The trial is a multicenter, multinational trial that is assessing the safety and efficacy of the drug in combination with prednisone as second-line chemotherapy in patients with the
At the meeting, the FDA requested additional information from the two ongoing phase IIb clinical trials evaluating valopicitabine. In response, Idenix plans to provide the FDA with comprehensive
The patch, known as Daytrana, was licensed to Shire from its original developers Noven Pharmaceuticals, and is under review to treat attention deficit hyperactivity disorder (ADHD) in children
A priority review designation is assigned by the FDA for those applications that have the potential for providing a significant therapeutic advance. “Doctors treating patients with gastric cancer
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