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Study finds no association between gene variant and risk of coronary disease

A genetic marker touted as a predictor of coronary artery disease is no such thing, according to a study led by researchers at the Stanford University School of Medicine.

7 Oct 2010

Onyx Pharmaceuticals announces delay in NDA filing for carfilzomib

Onyx Pharmaceuticals, Inc. today announced that it will delay its New Drug Application (NDA) filing for carfilzomib based on a recent meeting with the Chemistry, Manufacturing and Controls (CMC) review division of the U.S. Food and Drug Administration (FDA).

7 Oct 2010

First Edition: October 7, 2010

Today's headlines include stories on waivers given some companies that offer only minimal health insurance coverage, insurers' political efforts during this campaign season and efforts in New York to bar the use of food stamps to buy soda.

7 Oct 2010

Researchers unveil clues to combat enteritis in humans

The bacterium Campylobacter jejuni is a major cause of food poisoning in humans. It is normally transmitted from contaminted chicken meat, as it is frequently found in the intestines of chickens, where it apparently does not result in any symptoms. Researchers at the University of Veterinary Medicine, Vienna have now solved the puzzle, showing that Campylobacter can survive ambient oxygen levels thanks to the presence of other bacteria, species of Pseudomonas.

7 Oct 2010

Twenty-two countries face 'protracted crises,' increased likelihood of food insecurity, U.N. report says

Twenty-two countries "are facing enormous challenges like repeated food crises and an extremely high prevalence of hunger due to a combination of natural disasters, conflict and weak institutions," the U.N. Food and Agriculture Organization's and the World Food Program said in the State of Food Insecurity in the World 2010 report on Wedensday, Xinhua News reports.

7 Oct 2010

ANDA approved for Losartan Potassium Tablets USP, Losartan Potassium and Hydrochlorothiazide Tablets

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application for Losartan Potassium Tablets USP, 25mg, 50mg and 100mg as well as Losartan Potassium and Hydrochlorothiazide Tablets, 50mg/12.5mg and 100mg/25mg by the U.S. Food and Drug Administration. Both products are available for immediate shipment to wholesalers and pharmacies nationwide.

7 Oct 2010

Medical device industry, advocates weigh in on proposed expedited approval process

The Hill's Healthwatch blog reports that consumer groups and device makers are weighing in on a proposal to expedite the approval process for some medical devices.

7 Oct 2010

Neoprobe completes pre-NDA assessment for Lymphoseek with FDA

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has completed a pre-NDA assessment for Lymphoseek with the U.S. Food and Drug Administration (FDA).

7 Oct 2010

Pharmaxis receives FDA approval to market ARIDOL Test Kit

Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for chronic respiratory and immune disorders, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit, the first new bronchial challenge test in more than two decades.

7 Oct 2010

Vitamin D deficiency may impact orthopaedic procedure outcomes

Forty-three percent of patients scheduled to undergo orthopaedic surgery have insufficient levels of vitamin D and two out of five of those patients had levels low enough to place them at risk for metabolic bone disease, according to a study published this month in the October 6th issue of the Journal of Bone and Joint Surgery (JBJS).

7 Oct 2010

FDA awards cooperative agreement to PAHO to develop information hub for medical products

The U.S. Food and Drug Administration today announced the award of a $904,000 cooperative agreement to the Pan American Health Organization (PAHO) to research and develop an information hub for medical products and related regulatory processes and systems in the Americas Region.

7 Oct 2010

FDA unveils report to advance regulatory science

The U.S. Food and Drug Administration today unveiled a report outlining the agency's plans to advance regulatory science through its Regulatory Science Initiatie.

7 Oct 2010

What to eat and drink when pregnant: New studies

There is fresh debate over drinking during pregnancy. Researchers agree that the area is “highly politically and morally charged”. According to Government advice women who are trying to conceive or who are pregnant should avoid alcohol because it has proved impossible to establish a safe level of alcohol consumption in pregnancy. Excess alcohol consumption during pregnancy can cause fetal alcohol syndrome that can lead to mental retardation, behavioral problems and birth defects.

6 Oct 2010

Survey of active, retired military officials highlights attitudes about foreign aid

Almost 90 percent of active and retired military officers say diplomacy and development initiatives can play a helpful role in reaching U.S. national security goals and that relying on only a strong military presence is not enough, according to a recent poll from the U.S. Global Leadership Coalition (USGLC).

6 Oct 2010

ISTA Pharmaceuticals announces Phase 1/2 clinical study results of bepotastine besilate nasal spray

ISTA Pharmaceuticals, Inc., today announced positive preliminary results from a Phase 1/2 clinical study of bepotastine besilate nasal spray conducted in Canada for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.

6 Oct 2010

Adeona completes enrollment in Part 2 CopperProof-2 clinical study

Adeona Pharmaceuticals, Inc., announced completion of 100% enrollment in Part 2 of its clinical study, A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2).

6 Oct 2010

Pathwork Diagnostics closes $30M Series C financing

Pathwork Diagnostics, Inc, a privately held molecular diagnostics company focused on oncology, today announced the closing of its $30 million Series C financing. Led by Alta Partners, the financing included participation from the company's existing investors: Abingworth, Advent Venture Partners, Novus Ventures, Prospect Venture Partners and Venrock.

6 Oct 2010

FDA clears Integra LifeSciences' Vu aPOD Prime anterior lumbar interbody fusion device

Integra LifeSciences announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Vu aPOD™ Prime anterior lumbar interbody fusion (ALIF) device.

6 Oct 2010

Research suggests carotenoids can support women's health

Only about a third of American women are meeting their fruit and vegetable intake recommendations, which means they are likely missing out on potentially important breast and ovarian health benefits. Along with vitamins, minerals and fiber, fruits and vegetables contain a type of phytonutrient called carotenoids, which research suggests help support women's health including breast and ovarian health.

6 Oct 2010

Aeterna Zentaris' AEZS-130 demonstrates potential as oral diagnostic test for AGHD

Aeterna Zentaris Inc., today announced that an interim review of a Phase 3 trial of AEZS-130 (macimorelin, SolorelTM), demonstrates the compound may provide a simple, well-tolerated and safe oral diagnostic test for Adult Growth Hormone Deficiency (AGHD). The data was presented earlier today by Beverly M.K. Biller, M.D. of the Harvard Medical School/Massachusetts General Hospital in Boston, at the 5th International Congress of the Growth Hormone Research Society (GRS) and the Insulin-like Growth Factors (IGF) Society in New York City.

6 Oct 2010

Food News and Research

Study finds no association between gene variant and risk of coronary disease

Onyx Pharmaceuticals announces delay in NDA filing for carfilzomib

First Edition: October 7, 2010

Researchers unveil clues to combat enteritis in humans

Twenty-two countries face 'protracted crises,' increased likelihood of food insecurity, U.N. report says

ANDA approved for Losartan Potassium Tablets USP, Losartan Potassium and Hydrochlorothiazide Tablets

Medical device industry, advocates weigh in on proposed expedited approval process

Neoprobe completes pre-NDA assessment for Lymphoseek with FDA

Pharmaxis receives FDA approval to market ARIDOL Test Kit

Vitamin D deficiency may impact orthopaedic procedure outcomes

FDA awards cooperative agreement to PAHO to develop information hub for medical products

FDA unveils report to advance regulatory science

What to eat and drink when pregnant: New studies

Survey of active, retired military officials highlights attitudes about foreign aid

ISTA Pharmaceuticals announces Phase 1/2 clinical study results of bepotastine besilate nasal spray

Adeona completes enrollment in Part 2 CopperProof-2 clinical study

Pathwork Diagnostics closes $30M Series C financing

FDA clears Integra LifeSciences' Vu aPOD Prime anterior lumbar interbody fusion device

Research suggests carotenoids can support women's health

Aeterna Zentaris' AEZS-130 demonstrates potential as oral diagnostic test for AGHD

Enhancing confidence in chemical ionization spectrometry data 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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