Tag: clinical trials
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FDA Sanctions Not Mentioned in Published Clinical Trials
10 February 2015. An investigation by a New York University journalism professor shows serious violations in clinical trials revealed in Food and Drug Administration inspections are largely not mentioned in reports of those trials in scientific journals. The findings of Charles Seife and his team from NYU’s journalism school were published yesterday in the journal…
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Activity Trackers Adapted for Clinical Trial Data
9 February 2015. Medidata Solutions, a company providing cloud-based services for clinical trials, is teaming with Garmin Ltd., a provider of mobile GPS systems, to capture data from Garmin’s activity trackers worn by patients in clinical trials. Financial terms of the collaboration were not disclosed. The deal involves integrating data from Garmin’s Vivofit activity trackers…
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Biosimilar Shown Effective for Rheumatoid Arthritis
4 February 2015. A biologic therapy for rheumatoid arthritis was shown to work as well as an approved name-brand biologic treatment in a late-stage clinical trial, according to findings released by biotechnology company Amgen. The study found Amgen’s biologic code-named ABP501 performed as well as adalimumab, marketed as Humira by AbbVie, in relieving symptoms of…
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Lung Cancer Antibody Given FDA Breakthrough Tag
2 February 2015. An experimental engineered antibody for treating lung cancer received a breakthrough designation from the U.S. Food and Drug Administration. Genentech, a biotechnology subsidiary of drug maker Roche, says breakthrough status was granted for its cancer immunotherapy code-named MPDL3280A to treat programmed death-ligand 1 or PD-L1 positive non-small cell lung cancer whose disease…
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Gene Therapy Biotech Raises $161M in IPO
30 January 2015. Spark Therapeutics Inc., a biotechnology company in Philadelphia, is raising $161 million in its initial public stock offering. The company, developing genetic therapies for inherited diseases, priced 7 million shares of its common stock at $23.00 a share. The stock trades on the NASDAQ exchange under the symbol ONCE, and as of…
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Trial to Test Drug to Delay Early-Onset Alzheimer’s
28 January 2015. A clinical trial is planned to test a current drug for epilepsy as a way to delay the early onset of Alzheimer’s disease. The late-stage trial undertaken by AgeneBio Inc., a start-up pharmaceutical company in Baltimore, is funded by a $900,000 grant from Alzheimer’s Drug Discovery Foundation. The trial aims to address…
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Trial Shows Drug Reduces Depression in One Day
27 January 2015. A clinical trial testing a new drug to treat major depressive disorder shows the drug improved symptoms in patients after a single dose within one day. The intermediate-stage trial was conducted by Naurex Inc., a biopharmaceutical company in Evanston, Illinois and a spin-off from Northwestern University. Naurex develops drugs for diseases of…
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FDA Approves Novartis Psoriasis Drug
21 January 2015. U.S. Food and Drug Administration approved the biologic drug secukinumab for adults with moderate to severe plaque psoriasis, a common skin disorder. Secukinumab, an antibody designed specifically to address the condition, is marketed by the pharmaceutical company Novartis under the brand name Cosentyx. Plaque psoriasis is the most common type of psoriasis, an…
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University Spin-Off Develops Bone Repair Technology
20 January 2015. A materials science research center and university spin-off company in Ireland are developing a technology using natural materials to repair bones in people and animals. The bone-repair technology is a product of Ireland’s Advanced Materials and BioEngineering Research (Amber) center at Trinity College in Dublin and SurgaColl Technologies in Cork, a spin-off…
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Trial Testing Gene Therapy for Rare Eye Disorder
20 January 2015. An early-stage clinical trial is underway testing a gene-repair therapy for choroideremia, a rare progressive genetic eye disorder that leads to blindness. The trial, conducted at Children’s Hospital of Philadelphia began enrolling its first patients, according to Spark Therapeutics, also of Philadelphia, the biotechnology company leading the study. Choroideremia is associated with…