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Quidel's RapidVue hCG lateral flow pregnancy immunoassay granted FDA 510(k) clearance

Quidel Corporation, a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's RapidVue® hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG).

2 Sep 2010

Media examine floods' impact in Pakistan

News outlets reported on the effects of major flooding in Pakistan and described the situation on the ground.

2 Sep 2010

DASH eating plan reduces heart disease risk in African Americans: Study

A new study suggests yet another reason for Americans to abandon their current fatty diets in favor of one rich in fruits and vegetables and low in saturated fat. Choosing these healthier options appears to significantly reduce the long-term risk of heart disease in patients with mildly elevated blood pressure, particularly African Americans.

2 Sep 2010

More health overhaul policies settling in

The Wall Street Journal: "Almost 2,000 employers and unions will be eligible to submit retirees' medical bills for reimbursement by a $5 billion federal fund, the Obama administration will disclose Tuesday, suggesting the fund will be spread widely but thinly." General Motors, Pepsi, Alcoa and Pfizer are among the major employers that are said to be signing up.

2 Sep 2010

FDA approves LUMIGAN eye drops for intraocular pressure reduction in open-angle glaucoma patients

Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved LUMIGAN (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

2 Sep 2010

World Bank calls for more integrated approach to global water management

"We can't properly tackle global priorities of food security, renewable energy, adaptation to climate change, public health and urbanization unless we manage water better," Julia Bucknall, water sector manager for the World Bank, said, according to a World Bank press release.

1 Sep 2010

pSivida announces FDA Priority Review status for Iluvien NDA

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 been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).

31 Aug 2010

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis, a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung.

31 Aug 2010

ESC issues revised practice guidelines for management of AF

The European Society of Cardiology today issued revised practice guidelines for the management of atrial fibrillation, including guidance on the role of a novel oral treatment, dabigatran etexilate, for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

31 Aug 2010

Halozyme identifies strategy to reintroduce HYLENEX

Halozyme Therapeutics, Inc. today announced the completion of its root cause investigation regarding HYLENEX manufacturing and has identified a corrective action plan and regulatory strategy to reintroduce HYLENEX to the market. Halozyme and Baxter are finalizing the materials for a meeting with the U.S. Food and Drug Administration to seek concurrence with the reintroduction strategy.

31 Aug 2010

New book explores history, benefits of tomato

A new history of the tomato in Italy by a University of Leicester historian throws some surprising insights on an item of food that we have been accustomed to think of as intrinsically Italian.

31 Aug 2010

Outpatient prevention programme by nurses reduces risk of recurrent complications in heart patients

A six-month outpatient prevention programme conducted by nurses has resulted in significant and sustained improvements in the control of cardiovascular risk factors, including high cholesterol or high blood pressure, in patients hospitalised for a heart attack or impending heart attack.

31 Aug 2010

EDIMS licenses First DataBank's National Drug Data File Plus database

First DataBank, a leading provider of drug databases that help drive patient safety, and EDIMS, a leading provider of interoperable emergency department (ED) information management systems, today announced they have licensed First DataBank's National Drug Data File (NDDF) Plus™ database to offer hospitals greater choice in trusted third-party drug database information to use and integrate with EDIMS ED electronic health record (EHR).

31 Aug 2010

Data monitoring committee recommends early termination following impressive results of AVERROES study

The data monitoring committee of the AVERROES study, seeing overwhelming evidence of the success of apixaban in the prevention of stroke in patients with atrial fibrillation who are unsuitable for the conventional treatment of warfarin, has recommended early termination of this study. The decision came after repeated review and careful consideration of all efficacy and safety data.

31 Aug 2010

Death toll expected to rise as flooding subsides in some parts of Pakistan

Pakistani government officials say the death toll from the country's flooding stands at more than 1,600 and it could rise significantly as flood waters recede and more bodies are identified, CNN reports (8/28). "There is no official estimate of the number of missing because mass displacements have made accounting for them almost impossible," according to Reuters (Haider, 8/29).

31 Aug 2010

Bionovo receives positive guidance for Menerba drug candidate

Bionovo, Inc. announced today that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba.

31 Aug 2010

Salmonella contamination drives retail sales of pasteurized shell eggs

Consumer demand for safe eggs has driven retail sales of pasteurized shell eggs up by more than 50% since Aug. 16 when the Food and Drug Administration (FDA) recommended their use to prevent illness from egg-related Salmonella Enteritidis, announced National Pasteurized Eggs (NPE).

31 Aug 2010

African-Americans at higher risk of developing stent thrombosis

African-American race is a distinct risk factor for developing life-threatening blood clots after receiving a drug-coated stent, according to research reported in Circulation: Journal of the American Heart Association.

31 Aug 2010

Ten million face hunger in Central Africa; Niger flooding exacerbates food shortage, leaves 200,000 homeless

Flash floods have "worsened an already chronic humanitarian crisis caused by drought" in central Africa where aid agencies have warned that "10 million people are already facing severe food shortages, particularly in the landlocked countries of Chad and Niger, after a drought led to the failure of last year's crops," the Independent reports.

31 Aug 2010

Amino acid arginine vital in fighting infection

Richard Lamb and his post doctoral fellow Virginie Mieulet, in the Faculty of Medicine & Dentistry, may be able to explain why proper nutrition is so vital in fighting infection.

31 Aug 2010