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Biodel seeks FDA marketing approval for VIAject

Biodel Inc. announced today that the U.S. Food and Drug Administration has accepted for review the company’s new drug application (NDA) seeking approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.

1 Mar 2010

FDA accepts for filing VIVUS' Qnexa NDA

VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa®, for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.

1 Mar 2010

Phytotechnologies can bring about much needed holistic approach

Phytotechnologies to Promote Sustainable Land Use Management and Improve Food Chain Safety - has just ended but the international community is still active and eager to maintain the vitality of this network.

1 Mar 2010

Oral immunotherapy promising for egg allergies, SLIT for milk allergies

Children with egg allergies who consume increasingly higher doses of egg protein - the very nutrient they react to - appear to gradually overcome their allergies, tolerating eggs better over time and with milder symptoms, according to research conducted at Johns Hopkins Children's Center and elsewhere.

1 Mar 2010

Positive antioxidant balance may help in better reproduction, barn swallow study shows

A balanced diet, exercise and reduced stress not only can lead to a longer life, but also better reproduction, according to a new study by a team of researchers, including one from Arizona State University, on barn swallow nutrition and mating habits.

1 Mar 2010

Study evaluates possible diet associations with ovarian cancer survival

2009 estimates projected that in the United States alone 21,550 new cases of ovarian cancer would be diagnosed and 14,600 women would die of the disease. Often diagnosed in late stages, ovarian cancer has an asymptomatic onset and a relatively low 5-year survival rate of about 45%. Consequently investigation linked to survivorship is critical.

1 Mar 2010

Inadequate sleep may lead to increase in belly fat

A study in the March 1 issue of the journal SLEEP shows that African-American and Hispanic young adults with short or long sleep durations had greater increases in belly fat over a five-year period compared with those who reported sleeping six to seven hours a night.

1 Mar 2010

FDA works closely with different states to investigate the outbreak of Salmonella Montevideo infections

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

1 Mar 2010

Caddisfly silk and sandcastle worm glue: Potential adhesives during surgery

Like silkworm moths, butterflies and spiders, caddisfly larvae spin silk, but they do so underwater instead on dry land. Now, University of Utah researchers have discovered why the fly's silk is sticky when wet and how that may make it valuable as an adhesive tape during surgery.

1 Mar 2010

Aprepitant drug can reduce nausea and vomiting when combined with other anti-nausea drugs

Bone marrow transplant patients say two of the most debilitating side effects of the treatment are nausea and vomiting caused by chemotherapy and radiation.

1 Mar 2010

ADVENTRX' ANX-530 NDA: FDA issues refuse to file letter

ADVENTRX Pharmaceuticals, Inc. announced today that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion). In the letter, the FDA indicated that the data included in the initial submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. FDA identified only the one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX plans to meet with the FDA as soon as possible to discuss its response.

1 Mar 2010

Childhood obesity prevention: Prenatal and infancy period upto age 5 crucial

Efforts to prevent childhood obesity should begin far earlier than currently thought-perhaps even before birth-especially for minority children, according to a new study that tracked 1,826 women from pregnancy through their children's first five years of life.

1 Mar 2010

Ratifying global tobacco control treaty: Opportunity for U.S. to lead struggle against tobacco usage

The fifth anniversary of the international treaty to address the global tobacco epidemic presents a significant opportunity for President Obama to continue his strong leadership on tobacco control by submitting the treaty to the Senate for ratification and urging its quick approval.

1 Mar 2010

Hygafem announces name change to WellBeing

Hygafem, the Georgia-based premier provider of full-service hygiene technologies, announced today that the company has changed its name to WellBeing. WellBeing is introducing a new and evolving touch-free hygiene and organizational wellness platform that communicates the company’s ongoing commitment to “green” hygiene services, excellence and innovation.

27 Feb 2010

MDB Capital Group selects Health Discovery as one of Top 50 “Best and Brightest” companies

Health Discovery Corporation announced today it has been selected by MDB Capital Group as one of its Top 50 “Best and Brightest” companies that will present at the invitation-only, 1st Annual Bright Lights Conference, the first public company conference to focus exclusively on companies with disruptive and market changing intellectual property.

27 Feb 2010

Cotton thread as core material in 'lab-on-chip' devices to detect kidney failure and diabetes

A discovery by Monash University scientists could see humble cotton thread emerge as a core material in low-cost 'lab-on-chip' devices capable of detecting diseases such as kidney failure and diabetes.

27 Feb 2010

Single submission of orphan drug designation annual report for both FDA and EMA

In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Both agencies have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products designated by both the United States and the European Union.

27 Feb 2010

Phadia AB plans to provide access for specialists to peanut allergen components

Today, at the 2010 Annual Meeting of The American Academy of Allergy, Asthma & Immunology (AAAAI) Phadia, the world leader in in vitro allergy diagnostics, announced plans to provide access for specialists to peanut allergen components. These plans support Phadia’s goal to expand collaboration with allergy and immunology specialists in order to advance the understanding of the clinical utility of allergen component test results.

27 Feb 2010

Shire receives marketing approval from FDA for VPRIV

Shire plc, the global specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients.

27 Feb 2010

Dabigatran as effective as warfarin in preventing subsequent strokes among atrial fibrillation patients

The drug dabigatran was as effective as the currently recommended drug – warfarin – in preventing a subsequent stroke among people with atrial fibrillation and prior stroke or transient ischemic attack – and it did so with less bleeding according to late-breaking science presented at the American Stroke Association's International Stroke Conference 2010.

27 Feb 2010