Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed NeulastaA (pegfilgrastim) - a recombinant human granulocyte colony-stimulating factor
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A study reported in The American Journal of Gastroenterology found a benefit for the administration of granulocyte colony-stimulating factor
(GCSF) in patients with severe alcoholic hepatitis, a condition with high short-term mortality.
com)-- Granulocyte-macrophage colony-stimulating factor
(GM-CSF) is a protein secreted by macrophages, T cells, mast cells, NK cells, endothelial cells and fibroblasts.
Several studies suggest that a number of cytokines are involved in the development of blood hypereosinophilia in cancer patients, particularly interleukin-5 (IL-5) and granulocyte-macrophage colony-stimulating factor
This leads to enhanced activity of the normal JH1 kinase activity of JAK2, which makes the mutated hematopoietic stem cells hypersensitive to the hematopoietic growth factors thrombopoietin, erythropoietin, insulin-like growth factor-1, stem cell factor, and granulocyte colony-stimulating factor
, resulting in trilinear myeloproliferation.
NeuVax consists of the E75 peptide derived from human epidermal growth factor receptor 2 (HER2) combined with the immune adjuvant granulocyte macrophage colony-stimulating factor
The vaccine, known as NeuVax, is composed of the E75 peptide, which is derived from human epidermal growth factor receptor 2 (HER2), mixed with granulocyte macrophage colony-stimulating factor
The authors report that cytokine release appeared to be influenced by p-NP exposures, with evidence of increased release of granulocyte-macrophage colony-stimulating factor
(GM-CSF), interferon-[gamma] (IFN-[gamma]), interleukin (IL)-1[beta] IL-4, and IL-10 (maximum effects at [10.
Some patients in the latter group also received granulocyte-monocyte colony-stimulating factor
(GM-CSF) or recombinant fowlpox granulocyte-macrophage colony-stimulating factor
Granulocyte-macrophage colony-stimulating factor
(GM-CSF) has been shown to be involved on the proliferation of keratinocytes and may enhance wound contraction and healing.
Since chemotherapy can destroy white blood cells that are important in fighting infection, cancer patients often receive a growth factor called granulocyte colony-stimulating factor
, or G-CSF, to help them recover healthy blood counts after treatment.