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Soligenix's OrbeShield granted FDA oral BDP orphan drug designation

Soligenix, Inc., a development stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

2 Jan 2013

First Edition: January 2, 2013

Today's early morning highlights from the major news organizations, including a number of reports about congressional efforts to avert the "fiscal cliff."

2 Jan 2013

News anchor shares experience about link between multiple sclerosis and dental mercury fillings

Nashville news anchor (Fox 17) Stacy Case will share her personal experience about the link between multiple sclerosis (MS) and dental mercury fillings on the January 3rd episode of CBS's The Doctors entitled "Dangerous Toxins."

2 Jan 2013

Crofelemer receives FDA approval for treatment of HIV associated diarrhea

Glenmark Pharmaceuticals Limited announced today that the US Food and Drug Administration has provided Marketing approval to its partner in US, Salix Pharmaceuticals Limited, for Crofelemer 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).

2 Jan 2013

Fructose linked to food-seeking behavior and food intake

In a study examining possible factors regarding the associations between fructose consumption and weight gain, brain magnetic resonance imaging of study participants indicated that ingestion of glucose but not fructose reduced cerebral blood flow and activity in brain regions that regulate appetite, and ingestion of glucose but not fructose produced increased ratings of satiety and fullness, according to a preliminary study published in the January 2 issue of JAMA.

2 Jan 2013

Positive attitude required for weight-loss efforts

Pep talk and self-encouragement have always remained a key factor for those wishing to achieve improved fitness success, especially those who are attempting to lose weight. While there are many reasons an individual may face difficulties in the face of a weight-loss plan, a recent article from She Knows highlights the importance of maintaining a positive attitude throughout these goals.

2 Jan 2013

Senate talks on 'fiscal cliff' moving slowly

Negotiations over a last-ditch agreement to head off large tax increases and sweeping spending cuts in the new year appeared to resume Sunday afternoon after Republican senators withdrew their demand that a deal must include a new way of calculating inflation that would lower payments to beneficiaries programs like Social Security and slow their growth.

31 Dec 2012

Oral Eliquis receives FDA approval for treatment of clots in non-valvular atrial fibrillation patients

The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

29 Dec 2012

Clinical approach to swallowing of foreign bodies

It is a well known fact that children often swallow things. Children aged 6 months to 6 years are most often affected, but even adults sometimes end up with a foreign body stuck in their throats-and not only there.

29 Dec 2012

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Aeterna Zentaris Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration ("FDA") on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.

29 Dec 2012

Females students drink more intensively in shorter periods of time

Researchers from the HealthyFit group at the University of Vigo have studied university students' lifestyles; their analysis, which includes alcohol and illegal drug consumption habits, sport and food, concludes that most students indulge in unhealthy behaviour. One of the main results of the study is the high consumption of alcohol.

29 Dec 2012

Behavioral changes and discipline needed to lose weight

Losing weight and saving money are perenially the top New Year's resolutions made by many Americans. But both require behavioral changes and a certain amount of discipline.

29 Dec 2012

Translating calories to miles prompts significant portion reductions

Food labels that translate the number of calories in a meal into the amount of miles a person would have to walk to burn off those calories may be the most effective for reducing calorie intake, show study findings.

28 Dec 2012

FDA clears Cepheid Xpert CT/NG molecular diagnostic test

Cepheid today announced that it has received clearance from the U.S. Food & Drug Administration to market Xpert CT/NG. Running on Cepheid's GeneXpert Systems, Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae. For the first time, same-day patient consultation and treatment is possible for the two most common sexually transmitted bacterial infections in the United States.

28 Dec 2012

Juxtapid receives FDA approval for treatment of rare cholesterol disorder

On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.

27 Dec 2012

Children diagnosed with food allergies experience bullying

Nearly a third of children diagnosed with food allergies who participated in a recent study are bullied, according to researchers at the Icahn School of Medicine at Mount Sinai. Almost eight percent of children in the U.S. are allergic to foods such as peanuts, tree-nuts, milk, eggs, and shellfish.

25 Dec 2012

Study reveals body's food clock on a molecular level

If the sinful excess of holiday eating sends your system into butter-slathered, brandy-soaked overload, you are not alone: People who are jet-lagged, people who work graveyard shifts and plain-old late-night snackers know just how you feel.

25 Dec 2012

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

Atopy patch tests predict oral tolerance in children with milk allergy

Results from an Italian study show that atopy patch tests could predict oral tolerance in children with gastrointestinal symptoms related to non-IgE-mediated cow’s milk allergy.

22 Dec 2012

Study demonstrates safety of using tPA for stroke in community hospital settings

From the moment a stroke occurs, patients must race against the clock to get treatment that can prevent lasting damage. Now, a new study shows the promise – and the challenges – of getting them state-of-the-art treatment safely at their local hospital, saving precious minutes.

21 Dec 2012