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FDA's advisory panel votes against approval of Medtronic Phased RF Ablation System

Medtronic, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices advisory panel voted against the Medtronic Phased RF Ablation System, the first atrial fibrillation ablation therapy under investigation for the treatment of persistent and long-standing persistent atrial fibrillation.

28 Oct 2011

Foreign aid investment saves millions of lives, reflects American leadership

Chris Collins, vice president and director of public policy at the Foundation for AIDS Research (amfAR), and Khai Hoan Tram, an Allan Rosenfield Fellow at amfAR, write in this Huffington Post opinion piece that what's missing from the discussion of foreign aid -- which accounts for approximately one percent of the U.S. national budget -- "is the fact that [it] is actually used to aid those in need while advancing our country's humanitarian and diplomatic goals.

28 Oct 2011

Gilead submits Quad NDA to FDA for treatment of HIV-1 infection

Gilead Sciences, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults.

28 Oct 2011

Mylan receives final FDA approval for Morphine Sulfate ER Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Morphine Sulfate Extended-release (ER) Tablets, 15 mg, 30 mg, 60 mg, 100 mg and 200 mg, the generic version of Purdue Pharma's MS Contin, an opioid analgesic for moderate to severe pain management.

27 Oct 2011

Medtronic initiates Symplicity System clinical study in treatment-resistant hypertension

Medtronic Inc. announced today the start of SYMPLICITY HTN-3, the company's U.S. clinical trial of the Symplicity Renal Denervation System for treatment-resistant hypertension.

From Medtronic 27 Oct 2011

Bayer's regorafenib Phase 3 trial on metastatic colorectal cancer meets primary endpoint

Onyx Pharmaceuticals, Inc. today announced results from a Bayer HealthCare Pharmaceuticals Phase 3 trial evaluating the investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

27 Oct 2011

U.N. officials warn Yemen facing humanitarian, health disasters

High-level officials from UNICEF and the World Food Programme (WFP) this week warned that "routine immunization of children has dropped by 40 percent in some areas of Yemen, leading to outbreaks of polio and measles and reflecting a growing collapse of public services in a country that is on the brink of a humanitarian disaster," IRIN reports.

27 Oct 2011

Surgeons freeze organoid units and regenerate TESI for short bowel syndrome

Surgeons at Children's Hospital Los Angeles have conducted a study that could put regenerative tissue treatment for short bowel syndrome one step closer to the bedside. The researchers were able to successfully isolate and store organoid units and later generate tissue-engineered small intestine (TESI) in a mouse model. The groundbreaking results were presented at the 2011 Annual Clinical Congress of the American College of Surgeons.

27 Oct 2011

Elan's third quarter total revenue increases 17% to $328.5 million

Elan Corporation, plc today reported its third quarter and first nine months 2011 financial results.

27 Oct 2011

FDA responds to Delcath's request for pre-NDA meeting

Delcath Systems, Inc. announced today that the U.S. Food and Drug Administration (FDA) has responded to the Company's request made in September for a pre-New Drug Application (NDA) meeting and has scheduled a date in mid-January 2012.

27 Oct 2011

New genomic approach can trace food-borne bacteria with unprecedented accuracy

With salmonella-tainted ground turkey sickening more than 100 people and listeria-contaminated cantaloupes killing 15 this year, the ability to detect outbreaks of food-borne illness and determine their sources has become a top public health priority.

27 Oct 2011

Super broccoli on the shelves to protect from heart disease

British scientists unveiled a new breed of broccoli that experts say packs heavy on nutritional values. The new broccoli was specially grown to contain two to three times the normal amount of glucoraphanin, a nutrient believed to help ward off heart disease. Glucoraphanin breaks fat down in the body, preventing it from clogging the arteries.

27 Oct 2011

Yo-yo dieting can affect appetite hormones for up to a year

A new study suggests that the ‘yo-yo’ effect that dieters experience of shedding pounds and gaining them back may be due to the persistence of hormones that drive the urge to eat even a year after weight loss.

27 Oct 2011

VitaYeast project to curb global malnutrition

Any way you slice it, bread that contains critical nutrients could help combat severe malnutrition in impoverished regions. That is the goal of a group of Johns Hopkins University undergraduate students who are using synthetic biology to enhance common yeast so that it yields beta carotene, the orange substance that gives carrots their color. When it's eaten, beta-carotene turns into vitamin A.

27 Oct 2011

BGI, UC Davis partner to create new sequencing facility in Sacramento

The University of California, Davis, and BGI, the world's largest genomic institute, based in China, have signed a historic agreement that will change the landscape of genomic sciences in California and the Western states, and foster critical breakthroughs in the areas of food security and human, animal and environmental health.

27 Oct 2011

Viewpoints: The health law and Wal-Mart; congressional probe into Planned Parenthood; trimming Medicare

When Wal-Mart endorsed President Obama's health care plan in 2009, CEO Mike Duke said it did so "to remove the burden that is crushing America's businesses and hampering our competitiveness in the global economy." That doesn't seem to be working out too well - for all Americans, and especially for Wal-Mart's employees.

27 Oct 2011

Tiny teeth in tatters

The tiny teeth of Australian toddlers are rotting and dental researchers at the University of Sydney are poised to start a long-term study to find out why.

25 Oct 2011

No link between Chantix and mental health problems says FDA

According to federal health officials this Monday Pfizer's anti-smoking drug Chantix – known as Varenicline, did not increase psychiatric problems like depression and suicidal thoughts in two studies, though the findings are not definitive.

25 Oct 2011

BPA exposure in mothers may affect unborn daughters’ behavior: Study

A new federal study revealed Monday in the journal Pediatrics shows that bisphenol A (BPA) - a chemical used widely in plastic bottles, metal cans and other consumer products could be linked to behavioral and emotional problems in toddler girls.

25 Oct 2011

Bio-Images and Medimetrics partner to deliver the next generation of smart pill technology

Bio-Images Research and Medimetrics Personalized Drug Delivery have today announced a partnership to introduce the IntelliCap to the global pharmaceutical industry as a clinical research tool. The announcement was made at the annual meeting of the American Association of Pharmaceutical Scientists, being held in Washington DC, USA, between 23 and 27 October 2011.

24 Oct 2011