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March 31, 2014
08:03 EDTHALOHalozyme announces that rrial of Hylenex recombinant met primary endpoint
Halozyme announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex recombinant and a new formulation of Hylenex currently under FDA review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion in comparison to no pre-treatment. In accordance with the trial protocol pre-specified analysis of the endpoints, data from the two patient groups treated with Hylenex formulations were pooled in comparison to a group consisting of patients using standard CSII with rapid acting analog insulin alone. Adverse events were similar across the treatment and control groups. The most common treatment related adverse event in the Hylenex groups was mild infusion site discomfort.
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May 27, 2015
08:33 EDTHALOHalozyme and Ventana enter into global agreement to develop companion diagnostic
Halozyme (HALO) and Ventana Medical Systems, a member of the Roche (RHHBY), announced a global agreement to collaborate on the development of, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20. The Ventana assay will be used to identify high levels of hyaluronan. HA is a glycosaminoglycan that can accumulate around cancer cells. Halozyme has announced plans for rollout of a global phase 3 clinical study in 2016 targeting metastatic pancreatic cancer patients with high HA levels using its PEGPH20 in combination with ABRAXANE and gemcitabine. Under the agreement, Ventana will develop an in vitro diagnostic, under design control, using Halozyme's proprietary HA binding protein, with the intent of submitting it for regulatory approval in the United States, Europe and other countries. The financial terms of the agreement were not disclosed.

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