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Leukine® is beneficial to patients with mild-to-moderate Alzheimer’s, finds study
europeanpharmaceuticalreview
March 26, 2021
In a Phase II trial, Leukine® (sargramostim) significantly reduced biomarkers of neurodegeneration and improved cognitive function.
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Researchers identify inflammatory protein associated with severe COVID-19
pharmatimes
March 11, 2021
A UK-based research team has identified a key inflammatory protein which could be linked to severe COVID-19, according to findings published in Science Immunology yesterday.
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MaxiVAX, Minaris Enter Cell Therapy Mfg. Agreement
contractpharma
February 23, 2021
MaxiVAX SA and Minaris Regenerative Medicine GmbH have entered into a manufacturing agreement for MVX-ONCO-2, a cell-based immunotherapy for the treatment of cancers such as chordoma, head and neck, and other solid tumors.
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FDA Grants Accelerated Approval to naxitamab for Neuroblastoma in Bone or Bone Marrow
americanpharmaceuticalreview
December 11, 2020
The U.S. Food and Drug Administration (FDA) granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and ...
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FDA Approves Danyelza
americanpharmaceuticalreview
December 08, 2020
The U.S. Food and Drug Administration (FDA) approved Danyelza (naxitamab-gqgk) for use in combination with granulocyte-macrophage colony-stimulating factor (GM¬-CSF) for the treatment of pediatric patients 1 year of age and older and adult patients ...
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Pelareorep-based combination therapy improves glioblastoma patient survival
europeanpharmaceuticalreview
November 26, 2020
In a Phase Ib trial, pelareorep with GM-CSF, chemoradiotherapy and temozolomide increased progression-free survival by an average of eight months.
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Roivant Doses First Patient in Pivotal BREATHE Clinical Trial Evaluating Gimsilumab in COVID-19 Patients for the Prevention and Treatment of Acute Respiratory Distress Syndrome
prnewswire
April 16, 2020
Roivant Sciences announced that the first patient was dosed at Temple University Hospital in Philadelphia in an adaptive, randomized, double-blind, placebo-controlled ...
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Partner Therapeutics Announces Trial to Evaluate Leukine® for COVID-19 Respiratory Illness
americanpharmaceuticalreview
March 30, 2020
Partner Therapeutics announced Leukine® (sargramostim, rhu-GM-CSF) is being assessed in the SARPAC trial (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19 – EudraCT #2020-001254-22).
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Roivant Develops Gimsilumab for ARDS Associated with COVID-19
americanpharmaceuticalreview
March 23, 2020
Roivant Sciences has engaged with regulators in the United States, Europe, and Asia to rapidly advance the clinical development of gimsilumab for the treatment ...
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I-Mab Biopharma Receives IND Approval from NMPA to Initiate Clinical Trials for its Anti-GM-CSF Monoclonal Antibody TJM2 in China
En-CPhI.CN
November 15, 2019
I-Mab Biopharma, a China and U.S.-based clinical-stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and ...