Category: Regulations
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Leukemia T-Cell Trial Stopped After Patients’ Deaths
FDA halted a clinical trial testing engineered T-cells as a treatment for leukemia, after 3 participants died. Update: Juno to resume engineered T-cell trial.
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Drug Reconciliation Program Cuts Hospital Readmission
Consultations with pharmacists on medications when patients leave the hospital for home are shown to reduce the rate of readmission to the hospital by half.
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Hundreds of U.S. Clinics Found Selling Stem Cell Services
A comprehensive Internet search finds nearly 600 clinics in the U.S. claiming to offer stem cell treatments, many having dubious scientific or medical validity.
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More Device Approvals, Higher Risks in Europe than U.S.
29 June 2016. An analysis of regulatory approvals and outcomes shows medical devices are reviewed and approved faster in Europe than the U.S., but also face more safety issues later on. A team from Kings College London and Harvard University published its findings yesterday in the journal BMJ. Researchers led by Aaron Kesselheim, a bioethicist…
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Glucose Drug Reduces Heart Disease in People with Diabetes
14 June 2016. A drug to reduce glucose levels was shown in a clinical trial to reduce serious heart disease in people with type 2 diabetes also at high risk of heart disease. Results of the late-stage trial testing the drug liraglutide, marketed by drug-maker Novo Nordisk under the brand name Victoza, appear in yesterday’s…
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Trial Underway Testing Drug to Reduce Chronic Cough
14 June 2016. A clinical trial testing a drug treating chronic cough — coughs continuing for 8 weeks or more — will begin recruiting participants in the U.K. to join other sites in the U.S. The U.K. sites are under the direction of National Institute for Health Research, testing a small molecule, or low molecular…
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FDA Approves Cholera Vaccine
13 June 2016. Food and Drug Administration approved for marketing the U.S. a vaccine to prevent cholera for travelers to regions in the world where contaminated food or water is causing the disease. Vaxchora by PaxVax Inc. in Redwood City, California is the first vaccine approved by the agency to prevent cholera. According to World…
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New Diabetic Eye Disease Drugs Shown Not Cost-Effective
10 June 2016. An evaluation of two new biologic drugs to treat diabetic macular edema, an eye disease caused by diabetes, show the drugs do not provide enough additional benefit over much less expensive treatments to justify their higher price tags. The team led by Adam Glassman of the Jaeb Center for Health Research in…
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Antibody Treatment Shown to Prevent Migraine
9 June 2016. A clinical trial shows an engineered antibody in one week reduced the number of headaches in people who experienced migraines for an average of 18 years. Results of the study testing the experimental treatment appear in yesterday’s issue of the journal Neurology, published by American Academy of Neurology. Migraine is a neurological syndrome…
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FDA Clears Insomnia Relief Device
8 June 2016. A device that helps people with insomnia get to sleep without taking drugs received clearance for marketing in the U.S. from the Food and Drug Administration. The device, developed by the company Cerêve in Pittsburgh, Pennsylvania, will require a prescription once it’s on the market in the U.S., expected in the second…