Generic Drug Approvals

Generic Drug Approvals. First-Time Generic Approvals. Mobic, Propecia, Zithromax

Insulin-Linked Genes Tied to Body’s Internal Clock


December 30th, 2009 by admin


Genes that regulate insulin in the body also play a role in the timing of the body’s sleep-wake cycle, researchers say, and this finding that could potentially lead to treatments for disorders that arise when circadian rhythms are disrupted.

The insulin-control system, which governs how the body processes sugar, may also reset our internal clock, according to the study published online Sept. 17 in Cell.

“People knew that the clock regulates many different processes, but what they didn’t realize was that when you tweak those processes, it feeds back and alters the clock,” study co-author Steve Kay, dean of the Division of Biological Sciences at the University of California San Diego, said in a university news release.

“What came out very strongly was this close relationship between circadian regulation and insulin signaling,” Kay explained. “There’s a reciprocal relationship between circadian dysfunction and metabolic dysfunction.”

According to Kay, mice with malfunctioning internal clocks get fat and develop diabetes. Chronic jetlag may cause similar problems in people, he noted.

“Understanding this close relationship between circadian regulation and metabolic homeostasis should provide novel ways of identifying new therapies for metabolic disease,” Kay said.

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More Teens Getting Needed Vaccines


December 23rd, 2009 by admin


While vaccination rates for adolescents in the United States are gaining ground, there is still a long way to go to meet Healthy People 2010 goals of 90 percent coverage, a new government report shows.

For the first time, the Healthy People goal was met for measles-mumps-rubella and Hepatitis B vaccinations among teens aged 13 to 15.

But vaccination rates for the three vaccines recommended for teens — which cover meningitis, cervical cancer and tetanus-diphtheria-whooping cough — hover at less than 50 percent. In fact, only three states, Arizona, New Hampshire and New York, had vaccination rates over 50 percent, according to the U.S. Centers for Disease Control and Prevention.

Vaccination rates for those three teen vaccines are increasing throughout the country, although there are substantial differences in the rates among states and local areas, according to the report in the Sept. 18 issue of the CDC’s Morbidity and Mortality Weekly Report.

“Coverage among teenagers for the three routinely recommended vaccines is increasing nicely, but we still have a long way to go to reach our national objective,” said Dr. Lance Rodewald, director of immunization services at the CDC.

Although there are racial and economic disparities in many areas of health care, vaccines for children is not one of them, Rodewald said.

“If you look across race and ethnicity, by vaccine, by coverage, there aren’t a lot of disparities in coverage, so that’s quite good to see,” Rodewald said.

“In fact, for HPV vaccine (human papillomavirus, which causes cervical cancer), the below-poverty rates are higher than the above-poverty rates,” he said.

Nationally, vaccination rates for the three most recommended adolescent vaccinations and one childhood vaccination increased from 2007 to 2008.

Specifically, coverage for the MCV4, the meningococcal conjugate vaccine for meningitis, rose from 32.4 percent to 41.8 percent, and rates for Tdap, the tetanus-diphtheria-pertussis vaccine, jumped from 30.4 percent to 40.8 percent.

The rate for one or more doses of HPV vaccine, which protects women from cervical cancer, increased (from 25.1 percent to 37.2 percent). And the number getting two doses of VAR — Varicella vaccine among those without disease history — nearly doubled (from 18.8 percent to 34.1 percent), the CDC reports.

Rodewald said that more needs to be done to get vaccine coverage where it should be. For new vaccines, such as the HPV vaccination, it can take up to 10 years for coverage to reach 90 percent.

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More Whole Grains May Mean Less Fat


December 16th, 2009 by admin


Eating more whole-grain foods may help reduce body fat in older adults, says a new U.S. study.

The study looked at the eating habits — including the consumption of whole-grain bread, brown rice, popcorn and other whole grains as well as fruits and vegetables — of 177 men and 257 women, who averaged 68 years old.

Overall, the participants consumed relatively low amounts of whole-grain foods, averaging 1.5 servings a day, and dietary fiber, averaging 18.6 grams a day. U.S. Department of Agriculture dietary guidelines recommend that older people consume three or more servings daily of whole-grain foods and 21 to 30 grams of dietary fiber a day.

Among the study participants, bread and cold breakfast cereals were the main sources of whole grains, and women were more likely than men to consume whole grains.

After adjusting for factors such as levels of physical activity, the researchers found that a higher intake of whole grains was associated with lower amounts of total body fat and abdominal fat.

People who consumed the highest amounts of whole grains had about 2.4 percent less total body fat and 3.6 percent less abdominal fat than those who ate the least. This difference was found to be related to fiber in cereal, but not in fruits or vegetables. When only cereal fiber was taken into account, those who consumed the most had 3.2 percent less body fat and 5 percent less abdominal fat than those who ate the least amount of cereal fiber.

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Health Tip: Eat Your Fruits and Veggies


December 9th, 2009 by admin


Eating lots of fruits and vegetables can help prevent chronic diseases, including cancer, research indicates.
Most fruits and vegetables offer great nutritional benefit while contributing little to your daily fat and calorie intake.
At the same time, they help you stay full, helping you to maintain a healthy body weight and prevent excessive weight gain.
Fruits and vegetables are rich in the minerals, vitamins and fiber your body needs.

Since childhood, lots of people have heard the parental plea to eat their fruits and vegetables.

The U.S. Centers for Disease Control and Prevention offers this insight on why eating fruits and veggies is so important:

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National Institute of Allergy and Infectious Diseases (NIAID)


December 2nd, 2009 by admin


HIV/AIDS began its deadly course in the United States mostly as a disease of young men, but today the epidemic touches people of all ages, including adults aged 50 and older. On September 18, the first National HIV/AIDS and Aging Awareness Day, we pause to recognize the importance of preventing HIV infection in this age group and understanding and addressing the unique health effects of the virus on older Americans.

Thanks to the advent of potent, multi-drug therapy against HIV in the mid-1990s, many HIV-infected Americans are living into their 50s and well beyond. Also, while the majority of new HIV infections are in younger Americans, individuals 50 years of age and older accounted for approximately 10 percent of all new HIV infections in the United States in 2006.[1]As a consequence of these trends, approximately one quarter of HIV-infected adults in the United States in 2007 were at least 50 years old.[2]

Older adults with long-term or new HIV infection experience complex interactions among HIV, antiretroviral therapy, age-related changes to the body, and, often, treatment for illnesses associated with aging. These interactions affect the health care needs and quality of life of older adults. It is imperative that we in the research community decipher the medical implications of aging with HIV and continue developing more sophisticated treatment approaches so these older adults can live longer, healthier lives.

It also is critical to prevent new HIV infections in older Americans by educating them about the importance of routine HIV testing and early diagnosis; how the virus is transmitted; behaviors that place them at risk for acquiring or transmitting the virus; and strategies, such as condom use and needle exchange, that can reduce their risk. Since early diagnosis of HIV is key to optimal treatment, the Centers for Disease Control and Prevention recommends routine HIV testing for all adults up to age 64.[3] CDC also recommends HIV testing at least annually for adults aged 64 and over who have risk factors for HIV infection, such as injection drug use.

The U.S. Department of Health and Human Services this month proposed that Medicare cover HIV screening tests for beneficiaries at increased risk for acquiring the virus, including women who are pregnant, and Medicare beneficiaries of any age who voluntarily request the service. Medicare provides health insurance coverage to people who are aged 65 and over or who meet other special criteria.

Aging is an important and expanding focus of HIV/AIDS research at the National Institutes of Health and the NIH-sponsored Centers for AIDS Research. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, funds a range of studies to understand the biology of HIV infection in older adults with the goal of improving their medical care. Scientists are studying the interaction between HIV and aging in areas as diverse as diseases of the liver, kidney, brain, heart and lung; cancer; bone density; physical activity; mental health; balance; hearing; response to antiretroviral therapy; immune function; and adherence to medical care.

For example, researchers with the Multicenter AIDS Cohort Study have shown that HIV infection accelerates the development of frailty, a condition of the elderly that makes people more vulnerable to illness, injury and death. Scientists now want to determine which HIV-infected individuals are at highest risk for developing HIV-associated frailty with the hope of identifying factors to mitigate or prevent its development. NIAID and the National Institute on Aging (NIA), also part of NIH, are planning a workshop for late 2009 to identify current knowledge and research gaps in the areas of HIV and frailty, bone health, muscle health and vitamin D production.

Still, many gaps remain in scientific knowledge about the effects of HIV and antiretroviral therapy on aging. To that end, NIAID, NIA, the National Institute of Mental Health and the National Institute of Nursing Research, all part of NIH, are soliciting research proposals to explain and prevent a spectrum of biomedical problems faced by older adults with HIV infection. More information about these funding opportunities is available at http://grants.nih.gov/grants/guide/pa-files/PA-09-018.html, http://grants.nih.gov/grants/guide/pa-files/PA-09-019.html, and http://grants.nih.gov/grants/guide/pa-files/PA-09-017.html.

When AIDS and then its cause — HIV — were recognized in the early 1980s, no one imagined that individuals with HIV infection would eventually survive for decades. Now, with a quarter of the HIV-infected U.S. population age 50 years and older, the biomedical and public health communities face new challenges at the intersection of HIV and aging. In the absence of a cure for HIV, this first annual National HIV/AIDS and Aging Awareness Day marks an opportunity to rededicate ourselves to research aimed at preventing HIV infection in older adults and improving the health and quality of life of those who are infected.

Dr. Fauci is director of the National Institute of Allergy and Infectious Diseases;, Dr. Hodes is director of the National Institute on Aging; and Dr. Whitescarver is director of the Office of AIDS Research, all at the National Institutes of Health in Bethesda, Maryland.

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