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e-cigarettes spark debate in U.S.

Electronic cigarettes have been seen as a tobacco product but not as drugs. The US Food and Drug Administration had appealed to the court to treat these cigarettes as drugs but the court says this is an oversight. The FDA cited five e-cigarette distributors for poor manufacturing practices and falsely claiming that the products help people stop smoking.

8 Dec 2010

FDA clears Valeritas' V-Go Disposable Insulin Delivery Device

Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced today that the US Food and Drug Administration has cleared the company's V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin.

8 Dec 2010

Bavarian Nordic receives SPA for Phase 3 study of PROSTVAC for advanced prostate cancer

Bavarian Nordic A/S announced today that the company has received a letter of concurrence from the U.S. Food and Drug Administration on a Special Protocol Assessment for a Phase 3 study required for product registration for its product candidate, PROSTVAC, for the treatment of patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

8 Dec 2010

TOS, OAC call on FDA to address urgent need for obesity treatments

The Obesity Society (TOS) and the Obesity Action Coalition (OAC) today called on the Food and Drug Administration (FDA) to consider the urgent need for more tools to address the obesity epidemic facing more than 93 million Americans as they convene an advisory panel to review a new treatment for obesity.

8 Dec 2010

Court ruling on regulation of electronic cigarettes as drugs and devices is wrong

A federal appeals court ruling today that the U.S. Food and Drug Administration (FDA) cannot regulate electronic cigarettes as drugs and devices is wrong on the law, wrong on the facts and fails to take into account the harmful implications of this decision for public health. This decision will allow any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time. We urge the government to appeal this ruling.

8 Dec 2010

FDLI to launch Food and Drug Policy Forum publication in 2011

In 2011, the Food and Drug Law Institute will launch a new publication — FDLI"s Food and Drug Policy Forum. "The Policy Forum is designed to provide a new electronic marketplace for the exchange of ideas among food and drug law, regulation, and policy professionals," notes Susan C. Winckler, President and CEO of FDLI.

8 Dec 2010

New NIH guidelines support broader use of blood tests to diagnose food allergy

New guidelines on diagnosis and management of food allergy issued by the National Institute of Allergy and Infectious Diseases a part of NIH, supports a broader use of blood test to improve current clinical practice. Phadia's ImmunoCAP is recognized for its superior predictive values compared to other systems. It provides precise, quantitative and standardized results and help doctors make an accurate diagnosis.

8 Dec 2010

Video games effective in improving diet behaviors of children

Obesity in youngsters has risen dramatically in recent decades. Fruit and vegetable (FV) consumption and increased water intake can lower the risk of obesity, as can increased physical activity, but it is not always easy to convince children to eat better and exercise more. In a new study published in the January 2011 issue of the American Journal of Preventive Medicine, researchers found that video games designed to encourage these behaviors were effective.

8 Dec 2010

Overeating and drinking at holiday parties could affect those unaware of type 2 diabetes

For most people, overeating and drinking at holiday parties will just result in weight gain. However, for millions of others who do not know they have type 2 diabetes, it could mean something much more serious.

8 Dec 2010

Novel therapy against hepatitis C disease

University of Maryland School of Pharmacy researchers have developed a mathematical model for choosing an appropriate dosage of the hepatitis medications for individual patients. The work helps explain why African American patients tend to not respond as well to the drugs as other patients.

8 Dec 2010

Omega-3 fatty acids have antidepressant properties: Study

A new analysis of the effects of omega-3 essential fatty acids offers the hope of enhanced treatment options for tens of millions of people with depression. Two critical omega-3 essential fatty acids available from certain food or nutritional supplements but not manufactured by the body—Eicosapentenoic acid (EPA) and docosahexaenoic (DHA) — play a role in optimal brain functioning and have antidepressant benefits that have not been fully recognized.

8 Dec 2010

Vision community, FDA discuss use of PROs to improve labeling of ophthalmic treatments, products

The vision community is discussing with the Food and Drug Administration how vision-related patient-reported outcomes might be used in improving the labeling of ophthalmic treatments and products. The group — composed of researchers, clinicians, policymakers and representatives from industry and vision associations — attended a one-day symposium sponsored by the National Institutes of Health's National Eye Institute and the FDA on October 13, 2009.

8 Dec 2010

Loss of healthy bacteria may contribute to increasing rates of depression, say researchers

In an effort to pinpoint potential triggers leading to inflammatory responses that eventually contribute to depression, researchers are taking a close look at the immune system of people living in today's cleaner modern society.

8 Dec 2010

Nanoparticles could combat Listeria

A Purdue University research team developed a nanoparticle that can hold and release an antimicrobial agent as needed for extending the shelf life of foods susceptible to Listeria monocytogenes.

8 Dec 2010

Most of world's poorest still live in rural areas, despite progress over last decade, U.N. report says

A report from the U.N.'s International Fund for Agricultural Development found that approximately 350 million people living in rural areas have escaped extreme poverty over the past decade, but most of the world's poorest citizens continue to live in rural regions, the BBC reports (Melik, 12/6).

8 Dec 2010

Scientists work together to wipe out some of the most lethal diseases

Scientists at Seattle Biomedical Research Institute and Northwestern University Feinberg School of Medicine have reached a major milestone in the effort to wipe out some of the most lethal diseases on the planet. As leaders of two large structural genomics centers, they've experimentally determined 500 three-dimensional protein structures from a number of bacterial and protozoan pathogens, which could potentially lead to new drugs, vaccines and diagnostics to combat deadly infectious diseases.

8 Dec 2010

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

Alexza Pharmaceuticals, Inc. announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration in December to discuss the Complete Response Letter regarding the Company's New Drug Application for AZ-004 (Staccato loxapine).

8 Dec 2010

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave® (naltrexone sustained release (SR)/bupropion SR) outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval.

8 Dec 2010

QLT's oral synthetic retinoid granted orphan drug designation for treatment of Leber Congenital Amaurosis

QLT Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for QLT091001, its oral synthetic retinoid, for the treatment of Leber Congenital Amaurosis (LCA). LCA is an inherited progressive retinal degenerative disease that leads to retinal dysfunction and visual impairment beginning at birth. QLT091001 is an orally administered synthetic retinoid replacement for 11-cis-retinal, which is a key biochemical component of the visual retinoid cycle.

8 Dec 2010

Swissmedic authorizes Phase I/II clinical trial of human neural stem cells for chronic spinal cord injury

A therapy developed by Aileen Anderson and Brian Cummings of UC Irvine's Sue and Bill Gross Stem Cell Research Center in collaboration with researchers at StemCells Inc. will be the basis of the world's first clinical trial using human neural stem cells to treat spinal cord injury.

8 Dec 2010

Food News and Research

e-cigarettes spark debate in U.S.

FDA clears Valeritas' V-Go Disposable Insulin Delivery Device

Bavarian Nordic receives SPA for Phase 3 study of PROSTVAC for advanced prostate cancer

TOS, OAC call on FDA to address urgent need for obesity treatments

Court ruling on regulation of electronic cigarettes as drugs and devices is wrong

FDLI to launch Food and Drug Policy Forum publication in 2011

New NIH guidelines support broader use of blood tests to diagnose food allergy

Video games effective in improving diet behaviors of children

Overeating and drinking at holiday parties could affect those unaware of type 2 diabetes

Novel therapy against hepatitis C disease

Omega-3 fatty acids have antidepressant properties: Study

Vision community, FDA discuss use of PROs to improve labeling of ophthalmic treatments, products

Loss of healthy bacteria may contribute to increasing rates of depression, say researchers

Nanoparticles could combat Listeria

Most of world's poorest still live in rural areas, despite progress over last decade, U.N. report says

Scientists work together to wipe out some of the most lethal diseases

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

FDA Advisory Committee votes in favor of Orexigen's Contrave for treatment of obesity

QLT's oral synthetic retinoid granted orphan drug designation for treatment of Leber Congenital Amaurosis

Swissmedic authorizes Phase I/II clinical trial of human neural stem cells for chronic spinal cord injury

Enhancing confidence in chemical ionization spectrometry data eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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