Category: Regulations
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FDA Approves Age-Related Macular Degeneration Drug
The Food and Drug Administration approved the drug Eylea (aflibercept) to treat patients with neovascular age-related macular degeneration (AMD), also known as “wet” AMD. Regeneron Pharmaceuticals Inc. in Tarrytown, New York developed Eylea, in partnership with Bayer HealthCare in Germany. Wet AMD is a leading cause of vision loss and blindness in Americans ages 60…
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Fatigue, Poor Sleep Linked to EMS Safety, Work Quality
Fatigue and poor sleep affect many emergency medical services (EMS) workers, which appear linked to higher rates of injuries and medical errors, according to a study by researchers at University of Pittsburgh. The findings, with contributions from colleagues at Western Carolina University in Cullowhee, North Carolina and National Center for Human Factors Engineering in Healthcare…
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Study Outlines Regulatory Issues for Natural Gas Fracking
A new report by researchers at Duke University in Durham, North Carolina outlines health and environmental measures for lawmakers in that state to consider as they debate the use of horizontal drilling and hydraulic fracturing for natural gas. The study has been accepted for publication in the spring 2012 issue of the journal Duke Environmental…
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Treatment for Rare Bone Marrow Disease Gains FDA Approval
The Food and Drug Administration today approved the drug ruxolitinib, to treat the bone marrow disease myelofibrosis, for marketing in the U.S. Ruxolitinib is marketed under the brand name Jakafi by Incyte Corporation, a biotechnology company in Wilmington, Delaware. Jakafi is a pill taken two times a day to inhibit enzymes called Janus Associated Kinase…
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FDA Approves Touch-Screen Insulin Pump System
Tandem Diabetes Care Inc. in San Diego says the Food and Drug Administration has cleared the company’s insulin pump system for marketing in the U.S. The t:slim Insulin Delivery System, as it’s called, is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative, according to the company.…
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Trial of Insulin-Coated Gold Nanoparticles Approved
Midatech Ltd. in Oxford, U.K. says it has received approval from regulatory authorities in Switzerland for a clinical trial of the company’s insulin-coated gold nanoparticles. The company says it is the first test in humans of therapies based on solid nanoparticles. Midatech says the trial will test the safety of insulin-coated gold nanoparticles when applied…
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FDA Funds Evaluation of Pain Drug Clinical Trial Methods
The Food and Drug Administration is funding a study by researchers at University of Rochester in New York and University of Washington in Seattle to find different ways of evaluating drugs designed to relieve acute and chronic pain. The grant of up to $4.5 million over five years aims to better understand why few new…
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Full Coverage of Meds Reduces Later Heart Attacks, Failures
Academic and industry researchers have found heart attack patients whose insurance fully covered their medications had lower rates of rehospitalization for heart attack or heart failure compared to patients who had prescription co-pays. The team from Brigham and Women’s Hospital and Harvard Medical School in Boston, Aetna Insurance in Hartford, Connecticut, and CVS Caremark in…
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Intentional Poisonings Result in 14K+ Emergency Room Visits
A study by the Substance Abuse and Mental Health Services Administration (SAMHSA) shows intentional poisonings — purposeful attempts to drug other people without their knowledge — resulted in 14,720 hospital emergency room visits in 2009. The report by SAMHSA, an agency of the Department of Health and Human Services, indicates most victims were female (63%)…
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Depression Drug Fails in First Phase 3 Trial
A drug candidate designed to treat major depressive disorder has not met its success targets in the first round of phase 3 clinical trials. The drug, TC-5214 (S-mecamylamine), is made by global pharmaceutical company AstraZeneca and Targacept Inc., biotechnology company in Winston-Salem, North Carolina. The clinical trial tested TC-5214 as a therapy for major depressive…