Vaccine Candidate Gets Orphan Drug Status for Glioblastoma Treatment
VBI-1901 is an investigational bivalent eVLP vaccine immunotherapeutic candidate designed to target 2 highly immunogenic CMV antigens, gB and pp65.
VBI-1901 is an investigational bivalent eVLP vaccine immunotherapeutic candidate designed to target 2 highly immunogenic CMV antigens, gB and pp65.
Omburtamab is an investigational radiolabeled monoclonal antibody designed to target tumor cells that express B7-H3.
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
The application could not be approved in its present form due to manufacturing deficiencies.
Oblato plans to evaluate OKN-007 for diffuse intrinsic pontine glioma in a phase 1/2 trial this year.
Chemotherapy agents such as vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection should only be prepared in IV infusion bags.
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This week the FDA and the WHO have a back and forth over remdesivir; Who should get a COVID vaccine; Xolair and Hetlioz have approval expansions; And a novel neuroblastoma treatment gets accelerated approval.
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
he designation is supported by data from a phase 1 trial conducted by Reata Pharmaceuticals in 2016. Findings from the study showed 44% of patients treated with berubicin (n=11 out of 25) experienced a statistically significant improvement in progression free survival.