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U.S. special envoy to Pakistan highlights U.S. flood relief efforts

Richard Holbrooke, the U.S. special envoy to Pakistan, sought to highlight Washington's aid efforts Wednesday during his first visit to the country since the severe floods hit, the Associated Press reports.

17 Sep 2010

Arena, Eisai provide update on lorcaserin NDA

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in a population of overweight and obese individuals to allow marketing approval.

17 Sep 2010

Media reporting can reduce impact of infectious disease outbreaks

At the first sign of a disease pandemic, public health officials should begin strongly communicating about the extent of the outbreak and the steps that can be taken by the public to avoid infection. That's the recommendation of two mathematical biologists who have modified the most widely used infectious disease transmission model to account for the impact of news media coverage.

17 Sep 2010

NIH to implement ScriptPro pharmacy automation systems

ScriptPro has been awarded a contract to provide pharmacy automation systems to the National Institutes of Health (NIH) in Bethesda, MD.

17 Sep 2010

Phosphorus additives leads to health disparities in chronic kidney disease

Processed and fast foods enriched with phosphorus additives may play a role in health disparities in chronic kidney disease, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

17 Sep 2010

Researchers suggest DASH-style diet reduces kidney stone formation

Certain key ingredients of a diet designed to prevent high blood pressure can ward off kidney stones, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN). The results suggest how low-fat dairy products and/or plants may have potent kidney stone-fighting properties.

17 Sep 2010

Seattle uses global lessons to help local poor with health care

The Seattle Times: "Seattle is known for taking its health expertise to the developing world. Now some fruits of that work are coming back to address health issues locally.

17 Sep 2010

FDA approves expanded indication for Boston Scientific's CRT-Ds

Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS® CRT-D. The exclusive expanded indication is effective immediately and makes Boston Scientific CRT-Ds the only devices approved by the FDA for patients in all New York Heart Association (NYHA) classes of heart failure.

17 Sep 2010

Alcohol addiction drug may help opioid addicts: FDA panel considers reports

A U.S. Food and Drugs Administration (FDA) panel, this Thursday agreed that a new drug Vivitrol helps alcoholics and opioid addicts kick the habit. The panel voted 11 to 2 that there was sufficient evidence from a single clinical trial that Vivitrol is effective when it comes to helping people addicted to painkillers.

17 Sep 2010

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

17 Sep 2010

Medtronic Deep Brain Stimulation Therapy for severe epilepsy receives CE Mark approval

Medtronic, Inc. today announced that the company has received CE (Conformité Européenne) Mark approval for Medtronic Deep Brain Stimulation (DBS) Therapy in Europe as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy. DBS therapy for epilepsy delivers controlled electrical pulses to a target in the brain called the anterior nucleus of the thalamus, which is part of a circuit involved in seizures.

17 Sep 2010

FDA approves CRT-D device to treat heart failure patients

The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients.

17 Sep 2010

China-Biotics files two new patent applications

China-Biotics, Inc., the leading developer, manufacturer and distributor of probiotics products in China, today announced that it has submitted two new patent applications to the State Bureau of Intellect Property.

17 Sep 2010

FDA grants AGTC $1M for Phase II human clinical trial in alpha-1 antitrypsin deficiency

Applied Genetic Technologies Corporation, a privately-held, clinical stage biotechnology company developing novel systems to deliver human therapeutics, announces that it has received a grant of $1 million from the Food and Drug Administration (FDA Orphan Drugs Program) to fund a Phase II Human Clinical Trial evaluating the safety and efficacy of a treatment for Alpha 1 Antitrypsin Deficiency (AAT), a genetic disease known to result in serious lung and/or liver disease.

17 Sep 2010

FDA approves Akorn's Erythromycin Ophthalmic Ointment USP 1 g

Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Erythromycin Ophthalmic Ointment USP 1 g as a supplement to the Company's already approved Abbreviated New Drug Application (ANDA) for Erythromycin Ophthalmic Ointment USP 3.5 g. The company has begun shipping the product to its customers.

17 Sep 2010

Abbott to present two drug eluting stents data at TCT symposium

Abbott today announced the company's schedule of key data presentations at the Cardiovascular Research Foundation's 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., to be held Sept. 21 – 25.

17 Sep 2010

ISTA Pharmaceuticals initiates REMURA Phase 3 clinical program for dry eye disease

ISTA Pharmaceuticals, Inc., today announced that it has initiated a Phase 3 clinical program of ISTA's proprietary formulation of REMURA (bromfenac ophthalmic solution for dry eye) for alleviating the signs and symptoms of dry eye disease. The Phase 3 efficacy studies are being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA).

16 Sep 2010

CDPAC to work with health ministers on concrete actions to address childhood obesity

The Chronic Disease Prevention Alliance of Canada (CDPAC), a coalition comprised of ten national organizations committed to integrated action for chronic disease prevention in Canada, commends the federal, provincial and territorial ministers of health for their commitment to address the issue of childhood obesity at their meeting in St. John's Newfoundland yesterday.

16 Sep 2010

Forest Pharmaceuticals to pay $300 million as penalty for criminal actions

The U.S. Food and Drug Administration (FDA), working in close coordination with the U.S. Department of Justice (USDOJ), today announced that Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.

16 Sep 2010

Data finds U.S. adults perform sedentary, light activities

On any given day, most U.S. adults report performing predominantly sedentary and light activities, according to a new study published in the October issue of the American Journal of Preventive Medicine. Overall only 5.07% report any vigorous intensity activity. The most frequently reported moderate activity was food and drink preparation.

16 Sep 2010