Tag: FDA
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Trial to Test Engineered DNA Therapy for Preeclampsia
31 March 2014. The biopharmaceutical company rEVO Biologics in Framingham, Massachusetts is starting a clinical trial of its drug ATryn to treat women in mid-pregnancy with preeclampsia. The company says the U.S. Food and Drug Administration gave its approval for the trial to begin. Preeclampsia is a life-threatening condition resulting from a sudden rise in…
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Biotech Group Issues Clinical Trial Data Sharing Guidelines
25 March 2014. Biotechnology Industry Organization (BIO) today released its principles for sharing data from clinical trials that encourage making more data available from clinical trials, but leave procedures for sharing up to the individual companies. The guidelines cover programs resulting in approved medicines, as well as those discontinued for safety or efficacy reasons, although…
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FDA Approves Celgene Psoriatic Arthritis Treatment
24 March 2014. The U.S. Food and Drug Administration on 21 March approved the drug apremilast to treat adults with active cases of psoriatic arthritis. The drug is marketed as Otezla by the pharmaceutical company Celgene in Summit, New Jersey, that also reported results of clinical trials of Otezla to treat the related skin condition…
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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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Pharma Alliance Extends Cancer Antibodies to Eye Disorders
4 March 2014. Santen Pharmaceutical Co. in Osaka, Japan is licensing antibodies developed as a cancer therapy by Tracon Pharmaceuticals in San Diego as treatments for eye diseases. Tracon is expected to earn $10 million in an upfront payment from Santen, as well as undisclosed milestone payments and royalties. Tracon develops biologic therapies for cancer,…
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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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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…
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FDA Approves Spine Compression Fracture Implant Device
28 January 2014. An implant device to treat vertebral compression fractures, made by Benvenue Medical Inc. in Santa Clara, California, was approved for sale in the U.S. by the Food and Drug Administration. The company’s Kiva VCF System treats vertebral compression fractures that occur most often to people with osteoporosis, but can also happen in cases…
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FDA Fast-Track Granted to Cancer Therapy Side-Effects Drug
BioAlliance Pharma SA in Paris says its drug candidate to treat inflammation of the mucus membranes in the mouth, resulting from chemo- or radiation therapy to treat cancer, received fast-track status from the U.S. Food and Drug Administration. Validive, the drug’s brand name, is designed for patients with head and neck cancers. Oral mucositis is…