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Gore provides update on REDUCE Clinical Study of HELEX Septal Occluder for PFO closure

W. L. Gore & Associates (Gore) today provided an update on the Gore REDUCE Clinical Study, a prospective, randomized, multi-center, multi-national trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for Patent Foramen Ovale (PFO) closure in patients with history of cryptogenic stroke or imaging-confirmed Transient Ischemic Attack (TIA). The unique study, which includes up to fifty investigational sites in the U.S., Denmark, Finland, Norway and Sweden, is on track to meet its estimated completion in 2015.

9 Jul 2010

Cigarette smoking declines slowly among high school students: CDC survey

The latest survey of high school smoking rates, released today by the U.S. Centers for Disease Control and Prevention, shows that the nation continues to make gradual progress in reducing youth smoking, but declines have slowed significantly since 2003 and nearly one in five high school students still smoke.

9 Jul 2010

Department of Agriculture asks consumers to discard Milky Way Farm's hard cheddar cheese

The Department of Agriculture today advised consumers who purchased aged hard cheddar cheese made with raw milk from Milky Way Farm in Troy, Bradford County, to discard the product immediately because of potential bacterial contamination. The Bureau of Food Safety has identified 20 pounds of raw milk cheddar cheese that entered the consumer market.

9 Jul 2010

Que She herbal weight loss supplement contains harmful ingredients, FDA warns

The U.S. Food and Drug Administration today warned that Que She, marketed as an herbal weight loss supplement, contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions.

9 Jul 2010

Patients enrolled in CLARITY-AF study

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announces that more than 10 patients have now been enrolled in the CLARITY-study, comparing the efficacy, safety and efficiency of CARTO 3 System guided radiofrequency ablation using the NAVISTAR THERMOCOOL catheter versus fluoroscopy guided radiofrequency ablation using the Pulmonary Vein Ablation catheter (Ablation Frontiers, Medtronic) in patients with paroxysmal atrial fibrillation.

9 Jul 2010

Australian, Vietnamese researchers develop simple tool for identifying individuals at high risk of Type 2 diabetes

Australian and Vietnamese researchers have estimated the current prevalence of Type 2 diabetes in Vietnam, and have developed a simple tool for identifying individuals at high risk.

9 Jul 2010

NeuroPace submits PMA to FDA for world's first responsive neurostimulation system

NeuroPace, Inc. today announced that it has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its RNS® System, a novel investigational device that utilizes responsive neurostimulation to monitor and interrupt abnormal electrical activity in the brain before seizures occur. The PMA application is for an indication to treat people with medically refractory partial onset epilepsy originating from one or two locations in the brain.

9 Jul 2010

FDA approves Roxane's Naratriptan Tablets ANDA

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Naratriptan Tablets USP, 1mg and 2.5mg by the U.S. Food and Drug Administration. The product is available in bottles of 9 for immediate shipment to wholesalers and pharmacies nationwide.

9 Jul 2010

Roxane announces FDA approval for Anastrozole Tablets ANDA

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1mg by the U.S. Food and Drug Administration. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies nationwide.

9 Jul 2010

Qualaquin for treatment of night time leg cramps leads to serious side effects, FDA warns

The U.S. Food and Drug Administration today warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.

9 Jul 2010

American, Canadian officials discuss global health developments at recent G8, G20 summits

The recent G8 summit in Canada's Muskoka region took an important step forward in improving maternal and child health in developing countries, Canadian and American officials said at a forum Wednesday in Washington, DC.

9 Jul 2010

Roche Molecular Systems receives FDA clearance for new LightCycler MRSA Advanced Test

Roche Molecular Systems, Inc. announced today that the U.S. Food & Drug Administration (FDA) cleared its new LightCycler® MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the United States.

9 Jul 2010

pSivida submits MAA for Iluvien to UK MHRA

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has submitted a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien®.

8 Jul 2010

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease, chronic kidney disease, and iron deficiency anemia, announced today that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate, a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.

8 Jul 2010

Fibrocell Science completes enrollment in azficel-T histology study

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today the completion of enrollment of and first treatment visits for participants in its histology study (IT-H-001) of azficel-T. An autologous cell therapy, azficel-T is currently under review by the U.S. Food and Drug Administration for the treatment of moderate to severe nasolabial fold wrinkles.

8 Jul 2010

Alimera Sciences submits MAA for Iluvien to MHRA

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals has submitted a Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom for Iluvien (fluocinolone acetonide intravitreal insert).

8 Jul 2010

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR™ in the United States. Kiadis Pharma is currently enrolling patients in a multinational, pivotal clinical study at hospitals in Europe and Canada. With the approval of the IND, US hospitals will also participate in this study.

8 Jul 2010

Standard Process launches new ProSynbiotic product

By our first birthday, we've acquired over 400 bacterial passengers in our gastrointestinal tract. Our gut microbes, or "bugs," work to keep our complex and diverse gut ecosystem in balance. Unfortunately, the trials of daily life-stressful events, aging, diet, or immune challenges-can be hard on these bugs. Standard Process Inc. introduces a new product, ProSynbiotic, to help our body maintain a healthy, balanced gut ecosystem.

8 Jul 2010

Vitamin D receptor emerges as key player amid gut bacteria, scientists find

Within the human digestive tract is a teeming mass of hundreds of types of bacteria, a potpourri of microbes numbering in the trillions that help us digest food and keep bad bacteria in check.

8 Jul 2010

Optics Express publishes special focus issue on lung cancer imaging research

Advanced imaging technologies that promise to improve the development of effective drugs to treat lung cancer are the focus of the current special issue of Optics Express, an open-access journal published by the Optical Society (OSA). Research featured in the special focus issue on Imaging in Diagnosis and Treatment of Lung Cancer outlines standardized approaches to measure and compare tumor size, as well as to validate the accuracy of such measurements under defined settings.

8 Jul 2010

Food News and Research

Gore provides update on REDUCE Clinical Study of HELEX Septal Occluder for PFO closure

Cigarette smoking declines slowly among high school students: CDC survey

Department of Agriculture asks consumers to discard Milky Way Farm's hard cheddar cheese

Que She herbal weight loss supplement contains harmful ingredients, FDA warns

Patients enrolled in CLARITY-AF study

Australian, Vietnamese researchers develop simple tool for identifying individuals at high risk of Type 2 diabetes

NeuroPace submits PMA to FDA for world's first responsive neurostimulation system

FDA approves Roxane's Naratriptan Tablets ANDA

Roxane announces FDA approval for Anastrozole Tablets ANDA

Qualaquin for treatment of night time leg cramps leads to serious side effects, FDA warns

American, Canadian officials discuss global health developments at recent G8, G20 summits

Roche Molecular Systems receives FDA clearance for new LightCycler MRSA Advanced Test

pSivida submits MAA for Iluvien to UK MHRA

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Fibrocell Science completes enrollment in azficel-T histology study

Alimera Sciences submits MAA for Iluvien to MHRA

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Standard Process launches new ProSynbiotic product

Vitamin D receptor emerges as key player amid gut bacteria, scientists find

Optics Express publishes special focus issue on lung cancer imaging research

Understanding cultivated meat and its global potential eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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