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Archive for July, 2008

Barr confirms Xyzal tablet patent challenge

Thursday, July 31st, 2008

Barr Pharmaceuticals, Inc. has confirmed that its subsidiaries, Barr Laboratories, Inc. and PLIVA-Hrvatska D.O.O., have initiated a challenge of the patent listed by UCB Inc. in connection with its Xyzal(R) Tablets (levocetirizine dihydrochloride), 5mg.(original article)

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A counter to counterfeit drugs

Wednesday, July 30th, 2008

The counterfeiting of medicines has been known of since around 1990 and is a growing problem-in both developing and developed countries. Counterfeit medicines are estimated as more than 10% of the global medicines market and in some developing countries it is thought to be as high as 50%. One prediction is that global counterfeit drug sales will reach $75 billion by 2010.(original article)

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FDA seizes more than $24 Million in unapproved new drugs

Wednesday, July 30th, 2008

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.(original article)

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86 Percent Of Americans Could Be Overweight Or Obese By 2030

Wednesday, July 30th, 2008

Most adults in the U.S. will be overweight or obese by 2030, with related health care spending projected to be as much as $956.9 billion, according to researchers at the Johns Hopkins Bloomberg School of Public Health, the Agency for Healthcare Research and Quality and the University of Pennsylvania School of Medicine. Their results are published in the July 2008 online issue of Obesity.

“National survey data show that the prevalence of overweight and obese adults in the U.S. has increased steadily over the past three decades,” said Youfa Wang, MD, PhD, lead author of the study and associate professor with the Bloomberg School’s Center for Human Nutrition. “If these trends continue, more than 86 percent of adults will be overweight or obese by 2030 with approximately 96 percent of non-Hispanic black women and 91 percent of Mexican-American men affected. This would result in 1 of every 6 health care dollars spent in total direct health care costs paying for overweight and obesity-related costs.”

The researchers conducted projection analyses based on data collected over the past three decades from nationally representative surveys. Their projections illustrate the potential burden of the U.S. obesity epidemic if current trends continue.

“Our analysis also shows that over time heavy Americans become heavier,” says May A. Beydoun, a former postdoctoral research fellow at the Johns Hopkins Bloomberg School of Public Health.

“The health care costs attributable to obesity and overweight are expected to more than double every decade. This would account for 15 to 17 percent of total health care costs spent,” Wang says. “Due to the assumptions we made and the limitations of the available data, these figures are likely an underestimation of the true financial impact.”

Current standards define adults with a body mass index (BMI) between 25 and 29.9 as overweight and adults with a BMI of 30 or higher as obese. Both the overweight and obese are at an increased risk for developing a number of health conditions, including hypertension, type 2 diabetes, heart disease and stroke. Researchers estimate that children and young adults may have a shorter life expectancy than their parents if the obesity epidemic is left unaddressed.

The authors warned that obesity has become a public health crisis in the U.S. Timely, dramatic and effective development and implementation of corrective programs and policies are needed to avoid the otherwise inevitable health and societal consequences implied by their projections. If current trends continue, the researchers say that the U.S. Department of Health and Human Services will not meet its Healthy People 2010 initiative to increase the proportion of adults who are at a healthy weight and to reduce the proportion of adults who are obese.

Journal reference:

Youfa Wang, May A. Beydoun, Lan Liang, Benjamin Caballero and Shiriki K. Kumanyika. Will All Americans Become Overweight or Obese? Estimating the Progression and Cost of the US Obesity Epidemic. Obesity, Advance online publication, July 24, 2008 DOI: doi:10.1038/oby.2008.351

Adapted from materials provided by Johns Hopkins University Bloomberg School of Public Health.

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Corn protein, zein being researched for drug delivery

Tuesday, July 29th, 2008

The key to a better drug delivery method for cancer patients may be growing all across the Midwest, South Dakota State University research suggests.(original article)

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Estrogen treatments may sharpen mental performance in some women

Tuesday, July 29th, 2008

Estrogen treatments may sharpen mental performance in women with certain medical conditions, but University of Florida researchers suggest that recharging a naturally occurring estrogen receptor in the brain may also clear cognitive cobwebs.(original article)

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Barr confirms patent challenge of Sensipar tablets

Tuesday, July 29th, 2008

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Amgen Inc. in connection with its Sensipar Tablets (cincalcet hydrochloride), 30mg, 60mg and 90mg.(original article)

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Markers in blood and spinal fluid, and a new imaging agent, show promise for early detection of Alzheimer’s

Tuesday, July 29th, 2008

With the continued aging of the population and the growing epidemic of Alzheimer’s, early detection of the disease is crucial for risk assessment, testing new therapies, and eventual early intervention with better drugs, once they are developed. Four studies reported today at the Alzheimer’s Association’s 2008 International Conference on Alzheimer’s Disease (ICAD 2008) in Chicago bring us closer to that goal of early detection by describing advances in biomarkers.(original article)

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FDA approves first generic divalproex sodium for the treatment of seizures, bipolar disorder and migraine headaches

Tuesday, July 29th, 2008

The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.(original article)

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FDA poorly equipped to enforce off-label prescription drug marketing rules, GAO report finds

Monday, July 28th, 2008

FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft report compiled by the Government Accountability Office, the AP/Minneapolis Star Tribune reports.(original article)

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New antibiotics to fight MRSA

Monday, July 28th, 2008

A new paper by Shahriar Mobashery, Navari Family Professor in Life Sciences at the University of Notre Dame, and researchers in his lab provides important insights into promising new antibiotics aimed at combating MRSA.(original article)

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Antimicrobial sutures reduce infections in brain shunt surgery

Sunday, July 27th, 2008

Children born with hydrocephalus, or “water on the brain” must have shunts implanted to drain the fluid away from the brain to reduce harmful pressure.(original article)

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Barr confirms Fentora tablet patent challenge

Thursday, July 24th, 2008

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Cephalon, Inc. in connection with its Fentora(R) Tablets (fentanyl citrate buccal tablets), equivalent to fentanyl base 100 mcg, 400 mcg, 600 mcg and 800 mcg.(original article)

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U.S. authorities seize Xiadafil VIP tablets after company refuses to recall product

Thursday, July 24th, 2008

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.(original article)

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Study shows emergency physicians have good first instincts in diagnosing heart attacks

Thursday, July 24th, 2008

A study out of Wake Forest University Baptist Medical Center demonstrates emergency room doctors are correctly identifying patients who are having a heart attack, even when laboratory tests haven’t yet confirmed it.(original article)

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