Tag: FDA
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Breakthrough Status Given Parkinson’s Psychosis Drug
2 September 2014. Acadia Pharmaceuticals says the U.S. Food and Drug Administration designated its drug candidate pimavanserin as a breakthrough therapy for the treatment of psychosis associated with Parkinson’s disease. Acadia is a biopharmaceutical company in San Diego specializing in neurological and central nervous system disorders. Pimavanserin is Acadia’s lead therapy candidate, to be offered…
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FDA Approves Low-Dose Anti-Inflammatory for Arthritis Pain
25 August 2014. Iroko Pharmaceuticals LLC in Philadelphia says the U.S. Food and Drug Administration approved its low-dose formulation of the nonsteroidal anti-inflammatory drug diclofenac to treat pain from osteoarthritis. FDA in October 2013 already approved this drug, marketed under the name Zorvolex, as a treatment for mild to moderate pain in adults. Osteoarthritis is…
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Trial Crowdsources Lung Cancer Biomarker Screening
22 August 2014. A clinical trial at University of Colorado Cancer Center in Aurora is recruiting participants through an online campaign to find people with lung cancer that meet a specific genetic profile who would most likely respond to the drug being tested. The study is led by Ross Camidge, director of the center’s thoracic…
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Extended Hemophilia Therapy Lowers Bleeding Rates in Trial
22 August 2014. Results from a late-stage clinical trial show an extended-life therapy to control hemophilia reduces rates of bleeding among patients when used as a preventive medication. The biologic tested in the trial is an extended release version of Advate, an engineered form of blood coagulant proteins made by Illinois-based drug maker Baxter International…
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FDA Approves AFib Monitor Algorithm for Mobile Devices
21 August 2014. AliveCor Inc. in San Francisco says the U.S. Food and Drug Administration cleared an analytical processing algorithm to detect atrial fibrillation by its heart monitor designed for smartphones and tablets. FDA already cleared the basic AliveCor mobile device heart monitor system for marketing in the U.S. in February 2014. The company’s heart…
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Orphan Status Assigned to Kidney Disorder RNA Therapy
21 July 2014. Regulus Therapeutics Inc. in San Diego says the U.S. Food and Drug Administration designated its RNA therapy for Alport syndrome, a rare genetic kidney disease, an orphan drug. The therapy, code-named RG-012, shows promise in preclinical studies, including with lab mice. Alport syndrome affects about 1 in 50,000 newborns, a condition that…
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Personal Leukemia Immunotherapy Given Breakthrough Status
7 July 2014. The U.S. Food and Drug Administration designated as a breakthrough a personalized immunotherapy developed by University of Pennsylvania in Philadelphia to treat acute lymphoblastic leukemia that does not respond to other treatments or has relapsed. FDA assigns a breakthrough designation and accelerates review of drugs or biologic therapies that treat a serious…
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FDA Approves Motorized Exoskeleton for Spinal Cord Injury
27 June 2014. The Food and Drug Administration yesterday cleared for sale in the U.S. a motorized exoskeleton system for people with lower-body paralysis from spinal cord injury. The device, called ReWalk, is made by Argo Medical Technologies in Marlborough, Massachusetts, and according to FDA, the first system of its kind approved to help people…
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Late Trial Testing Topical Gel for Diabetic Nerve Pain
26 June 2014. A late-stage clinical trial testing a topical gel to treat diabetic nerve pain completed its enrollment, according to BioDelivery Sciences International in Raleigh, North Carolina, the study’s sponsor. The trial is the first of two clinical studies of Clonidine Topical Gel in preparation for the company’s new drug application with the U.S.…
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FDA Issues Draft Industry Guidance on Social Media
18 June 2014. The U.S. Food and Drug Administration issued draft guidance for medical products companies on their use of social media to communicate with patients. The agency announced yesterday the documents’ availability for comment in a blog post authored by Thomas Abrams, director of FDA’s prescription drug information office. Abrams says the documents —…