Clinical Trial Results
In recent years there have been a number of studies examining the association between coffee and its health benefits. Drinking coffee in moderation is said to offer protection against Parkinson disease, type 2 diabetes, colorectal cancer and Alzheimer's. And now, you can add one more to that list.
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FDA/Panel Decisions
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The FDA on Wednesday approved Bayer HealthCare's Xofigo injection for advanced prostate cancer, three months ahead of schedule. Xofigo had a priority review status with a decision date of Aug. 14, 2013.
Theravance Inc. (THRX) and GlaxoSmithKline Plc (GSK, GSK.L) said Friday the U.S. Food and Drug Administration has approved Breo Ellipta for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD. The FDA also approved the...
Warner Chilcott plc (WCRX) Thursday announced the United States Food and Drug Administration or FDA approval of a new oral contraceptive, norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets, for the prevention of pregnancy. The product does not currently have a brand...
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Daily Dose
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Derma Sciences Inc. has engaged Plexus Ventures to explore options for DSC127, its phase III investigational drug for diabetic foot ulcer healing, outside the U.S. The company said that the process is expected to take nine to 15 months and to culminate with one or more agreements covering specific geographies or countries in Europe, Asia and emerging markets.
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Shares of Nanosphere Inc. rose more than 17% to $3.27 in after-hours on Monday, following the announcement of a distribution and collaboration agreement with Hitachi High-Technologies Corp.
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Keryx Biopharmaceuticals Inc. is progressing with the U.S. phase II study of its experimental drug Zerenex for the management of phosphorus and iron deficiency in anemic patients with Stages 3 to 5 non-dialysis dependent chronic kidney disease, with top-line results expected in Q3 2013.
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FDA Recalls / Safety Alerts
Apotex Corp., on behalf of the manufacturer and pharmaceutical company Hospira, Inc (HSP) said it is conducting a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams as it fears the impacted lots may show precipitation or crystallization in IV bag or IV line after reconstitution.
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A total of 81 people in 18 states have fallen sick with Salmonella Saintpaul infection, which has been linked to imported cucumbers, as per the latest update from the U.S. Centers for Disease Control and Prevention.
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The FDA is warning pregnant women not to use certain migraine prevention medicines, especially Valproate products, because exposure to these drugs in utero can lower a child's IQ.
Nestlé USA's Pizza Division is recalling frozen pizzas of select varieties and production codes as the products may contain plastic fragments.
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FDA Drug Approvals
DateCompany NameTickerDrugEventOutcomeDetails
07/28/2013AVEO Pharmaceuticals, Inc.AVEOTIVOPATH aka Tivozanib (NDA)FDA decision on TIVOPATH for advanced renal cell carcinoma
07/18/2013Merck & Co Inc.MRKSugammadex sodium injection (NDA)FDA panel to review Sugammadex sodium for the proposed indications of routine reversal of moderate and deep neuromuscular blockade
06/15/2013Delcath Systems Inc.DCTHCHEMOSAT with melphalan hydrochloride (NDA resubmission) FDA decision on CHEMOSAT with melphalan hydrochloride for metastatic melanoma in liver
05/22/2013Merck & Co Inc.MRKSuvorexant tablets (NDA) FDA panel to review Suvorexant for insomnia
05/12/2013GlaxoSmithKline PLCGSK.L, GSKBREO ELLIPTA (NDA) FDA decision on BREO ELLIPTA for chronic obstructive pulmonary disease FDA Approved BREO ELLIPTA for chronic obstructive pulmonary disease on May 10, 2013
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FDA Device Approvals
Submission DateCompany NameTickerDeviceCategoryOutcomeDetails
02/18/2013EXACT Sciences Corp.EXASSecond module for stool DNA colorectal cancer screening test PMA
12/07/2012EXACT Sciences Corp.EXASFirst module for stool DNA colorectal cancer screening test PMA
11/27/2012GIVEN IMAGING LTDGIVNPillCam COLON 2 for visualization of lower gastrointestinal tract Regulatory Clearance
11/13/2012Guided Therapeutics, Inc.GTHP.OBLuViva Advanced Cervical Scan to detect cervical disease PMA (Amended)
09/05/2012Nomir Medical Technologies Noveon Podiatric Laser for temporary increase of clear nail in patients with onychomycosis 510 (k)
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Health News
Cancer sufferers who also have depression may be far more likely to die prematurely, reports a new study from researchers at Tilburg University in The Netherlands. For the study the reviewed survey data collected from 3,080 cancer survivors between 2008 and 2009. The cancer survivors in the study included those who had suffered endometrial cancer, colorectal cancer, lymphoma or multiple myeloma.
As many as one in five children in America suffer from some form of mental disability, according to a report from the Centers for Disease Control. The new study is the first from the CDC to examine the prevalence of mental illness amongst children. They found that attention deficit/hyper activity (ADHD) was the most commonly reported illness by parents.
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Science & Technology
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