Category: Regulations
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Trial Planned to Evaluate CTE Blood Test
A clinical trial is planned of a blood test to detect an indicator of chronic traumatic encephalopathy. or CTE. a neurodegenerative disease associated with collision sports.
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News Blackout Imposed on U.S. Science Agencies [Updated]
Multiple news services today are reporting that the Trump administration is ordering several U.S. government agencies conducting or funding scientific research to cease discussing its activities with the media or public officials.
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FDA Begins Cancer Product Review Center
The U.S. Food and Drug Administration is reorganizing its review of treatments for cancer into a structure that cuts across its traditional bureaucratic lines.
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Experimental Drug Shown to Reduce Tourette’s Symptoms
Results from a clinical trial show an experimental drug is effective in reducing the severity of tics in children with Tourette’s syndrome, a neurological disorder.
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Gene Expression Changes Found in Wound Healing Therapy
A clinical trial to reveal the mechanism of a cell therapy to treat venous skin ulcers found the therapy works by altering the gene expression activity of treated cells to resemble healthy tissue.
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Antibody Trials Stopped After Deaths Reported
The U.S. Food and Drug Administration halted early-stage clinical trials of a monoclonal antibody drug for leukemia after four deaths occurred from liver toxicity.
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Trial to Test Stem Cells for Treating Heart Failure
A clinical trial testing a treatment for heart failure using a patient’s own bone marrow stem cells is recruiting participants at the first two study sites.
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Brain Cancer Regression Shown with Engineered T-Cells
A patient treated with immune system cells genetically modified to attack his brain cancer reported regression of recurring tumors in the brain and spinal cord.
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FDA Approves Spinal Muscular Atrophy Drug [Updated]
A drug to treat spinal muscular atrophy, a genetic disorder causing the wasting away of muscle tissue in children and adults, was approved for sale in the U.S.
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Smartphone System Shown to Control Blood Glucose Levels
A bionic pancreas system using a smartphone was shown in a clinical trial to control blood glucose levels better than a commercial insulin pump in persons with type 1 diabetes.