Category: Regulations
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Drug Shown Effective With Stubborn Rheumatoid Arthritis
31 March 2016. A late-stage clinical trial shows a small-molecule drug reduces pain and inflammation in patients with rheumatoid arthritis, who stopped responding to earlier protein treatments. A report of the study testing the drug baricitinib, made by Eli Lilly & Company that sponsored the trial, appears in today’s issue of New England Journal of…
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Electronic Patch Offers Pain Relief, Cuts Medication Use
29 March 2016. A study of customers using an electronic patch to relieve chronic pain, shows the patch relieves muscular and skeleton pain over 6 months, enabling its users to reduce their need for pain drugs. The study was done by BioElectronics Corp. in Frederick, Maryland, developer of the device, which expects to present the…
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Wide Variation Found in Consumer Blood Tests
29 March 2016; updated. Researchers at a New York medical center found some wide differences in results from commercial blood tests marketed to consumers, with samples from 60 healthy adults. The team led by Mount Sinai Medical Center bioinformatics professor Joel Dudley and genomics professor Eric Schadt published their findings yesterday (28 March) in Journal…
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Clinical Trial Advances Dengue Vaccine Candidate
17 March 2016. A small-scale clinical trial testing an experimental vaccine with people given live dengue viruses shows the vaccine is effective in preventing dengue infections. The team from Johns Hopkins University and University of Vermont published its findings in yesterday’s (16 March) issue of Science Translational Medicine; paid subscription required. The vaccine, developed by…
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Biomarker Profiles Shown to Improve Ovarian Cancer Survival
14 March 2016. A clinical trial of people with ovarian cancer shows patients receiving treatments matching their particular molecular profiles survived an average of 9 months longer than those receiving one or more drugs not matching their biomarkers. Results of the study, conducted by Caris Life Sciences at 6 cancer care hospitals in the U.S.…
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FDA Gives Initial Clearance for Engineered Mosquitoes
11 March 2016. The U.S. Food and Drug Administration issued a preliminary report that self-limiting engineered mosquitoes will have no significant environmental impacts on the Florida Keys, where they plan to be tested. The report agrees with an environmental assessment by Oxitec Ltd., developer of the engineered mosquitoes, that the agency is releasing for public…
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Allergy Drug Shown to Allow Eating Small Peanut Amounts
7 March 2016. A new drug was shown in a clinical trial to allow most children and teens with food allergies to eat peanuts in small quantities. The results of the intermediate-stage trial were reported yesterday at the annual meeting of American Academy of Allergy, Asthma and Immunology in Los Angeles. Allergies to peanuts and other…
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Duchenne-Related Stem Cell Heart Therapy Trial Underway
22 February 2016. An early clinical trial testing a stem cell therapy for heart disease among individuals with Duchenne muscular dystrophy treated its first enrolled patient. The trial is conducted by Capricor Inc. in Los Angeles, developer of the treatments code-named CAP-1002, for cardiomyopathy or heart failure related to Duchenne muscular dystrophy. Duchenne muscular dystrophy is…
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Pain Medication Given FDA Breakthrough Tag
22 February 2016. A new drug to treat moderate to severe pain, now in clinical trials, received a breakthrough designation from the U.S. Food and Drug Administration. The drug, oliceridine, is made by Trevena Inc. in King of Prussia, Pennsylvania. Oliceridine addresses the same pain signals as opioid drugs that affect areas of the brain…
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FDA Approves New Epilepsy Drug
19 February 2016. The U.S. Food and Drug Administration approved a molecular therapy for epilepsy designed to supplement treatments for partial-onset seizures. The drug is brivaracetam, marketed as Briviact by UCB, a pharmaceutical company headquartered in Brussels, Belgium. Epilepsy is a neurological disorder where nerve cell activity in the brain is disturbed, causing seizures with symptoms…