Category: Regulations
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Trial Shows Drug Efficacy with Chronic Kidney Disease
11 March 2014. An intermediate-stage clinical trial by La Jolla Pharmaceutical Company in San Diego shows patients with chronic kidney disease taking the company’s drug candidate succeeded in improving their kidney functions, compared to similar patients taking a placebo. However, the drug code-named GCS-100 appears effective only in lower rather than higher doses. The findings are scheduled…
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Trial Shows Nasal Filter Helps Relieve Hay Fever Symptoms
7 March 2014. A clinical trial at Aarhus University in Denmark shows a small filter placed in the nose reduced symptoms of hay fever among allergy sufferers, compared to a placebo. The inventor of the filter, Peter Kenney, a doctoral candidate at Aarhus, and colleagues presented their findings earlier this week at a meeting of…
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Quality Assurance Techniques Proposed for Stem Cells
7 March 2014. Biomedical engineers at Harvard University proposed a scheme for assessing the quality of stem cells used in drug testing to assure they transform into the cells and tissue they purport to represent. The team from Harvard’s Disease Biophysics Group, led by Kevin it Parker, published its findings online yesterday in the journal…
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School Meal Standards Lead to More Fruit, Veggies Eaten
4 March 2014. A study by public health researchers at Harvard University shows children eating lunch at school increased their consumption of fruit and vegetables after new school lunch standards took effect. The team led by nutrition research fellow Juliana Cohen published its results online today in American Journal of Preventive Medicine. Cohen and colleagues…
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FDA Fast-Tracks Depression Drug from Northwestern Spin-Off
Naurex Inc., a biotechnology company in Evanston, Illinois, says the U.S. Food and Drug Administration granted fast-track status for its drug candidate code-named GLYX-13 to treat depression. GLYX-13 is Naurex’s lead product for treatment of central nervous system disorders. The company develops drugs for diseases of the central nervous system that stimulate N-Methyl-D-aspartate (NMDA) receptors,…
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Asthma Drug Helps Desensitize Multiple Food Allergies
28 February 2014. Medical researchers at Stanford University in California and Johns Hopkins University in Baltimore found in an early-stage clinical trial that an asthma drug dramatically reduces the time needed for patients to lower their sensitivity to several food allergies at one time. The team led by Stanford’s Kari Nadeau and Johns Hopkins’s Robert Hamilton…
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Clinical Trial Testing New, Current Breast Cancer Drugs
27 February 2014. The global pharmaceutical company Eisai Inc. is starting a late-stage clinical trial of its drug eribulin mesylate to treat certain types of recurring or metastatic breast cancer, compared to the current chemotherapy drug paclitaxel. The trial is a joint project of Eisai’s U.S. subsidiary, in Woodcliff Lakes, New Jersey, and Academic and…
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Fox Foundation Proposes Improving Trial Patient Recruitment
20 February 2014. Research managers at the Michael J. Fox Foundation for Parkinson’s Research in New York propose improvements in practices for recruiting patients for clinical trials to reduce obstacles that delay or even prevent trials from happening. The team led by Fox Foundation vice president Sohini Chowdhury presents its ideas in this month’s issue…
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New Clinical Trial Testing Drug for Huntington’s Disease
19 February 2014. Omeros Corporation in Seattle began an intermediate-stage clinical trial testing its compound code-named OMS824 to treat symptoms of Huntington’s disease. The company says it’s administering the first doses in the trial, which is expected to enroll 120 patients. Huntington disease is an inherited disorder in which nerve cells in certain parts of…
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FDA Speeds Lymph Node Detector Review for Head/Neck Cancer
18 February 2014. Navidea Biopharmaceuticals Inc. in Dublin, Ohio, says the U.S. Food and Drug Administration is giving the company’s diagnostic agent Lymphoseek priority review for detecting the spread of head and neck cancers to lymph nodes. FDA granted the accelerated review as part of its acceptance of Navidea’s supplemental new drug application to expand…