Category: Regulations
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FDA, Emulate to Test Organs-on-Chips for Drug Toxins
A joint venture between Food and Drug Administration and a developer of chip devices simulating human organs, is evaluating the chips as a way to test new drugs for toxic effects.
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Phones, Algorithms Boost Adherence to Stroke Meds
Results from a clinical trial show a smartphone-based remote monitoring program helps stroke patients stay on their blood clot medications and improve their health.
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FDA Shown Approving New Drugs Faster than Europe
An analysis of regulatory actions in the U.S. and Europe, shows the U.S. Food and Drug Administration approves more new therapies and faster than the European Medicines Agency.
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Triple-Drug Inhaler Shown to Cut COPD Attacks
Results from a year-long clinical trial show that an inhaler with three types of drugs reduces the number of COPD attacks compared to a common single-drug inhaler.
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Zika DNA Vaccine Begins Clinical Trial
A new clinical trial is underway testing a Zika vaccine that uses genetically-engineered DNA to generate an immune response against the disease.
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FDA Approves Multiple Sclerosis Therapy
The Food and Drug Administration approved a synthetic targeted antibody to treat multiple sclerosis in people with relapsing or steadily worsening forms of the disease.
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Trials, Registry Planned for Wound Care Device
A company making products for healing wounds is studying the ways one of its dressings is used in the field, to better understand the product’s role in wound care.
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Report: More Biotech Regulations Needed, and Soon
A new report from the National Academies calls for a more robust and responsive regulatory system to handle an anticipated flood of biotechnology products.
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Trial Shows Bioactive Glass Stops Bone Infections
Grafts of glass-based substitute material were shown in a clinical trial to stop bacterial bone infections from osteomyelitis, in most cases without additional antibiotics.
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Trial Underway to Test Cancer Immunotherapy Aid
A clinical trial began recruiting participants with advanced tumors to test a compound that helps treatments for cancer harnessing the immune system.