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January 6, 2011, 6:19 PM CT

How do data exclusivity periods affect

How do data exclusivity periods affect
Pharmaceutical companies and generic drug manufacturers have long been at odds over regulations about "data exclusivity," the period of time before generic manufacturers can make use of valuable clinical trial data.

A newly released study in the January 2011 issue of Health Affairs is the first to calculate the financial and social costs of limiting access to trial data and finds that extending the term of exclusive access will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades.

"Elected officials are unlikely to embrace legislation that would result in higher drug prices, but our research suggests that legislation to extend data exclusivity would spur innovation that would benefit future generations," explained Dana Goldman, main author, director of the Schaeffer Center for Health Policy and Economics at USC and Norman Topping Chair in Medicine and Public Policy at USC.

The pharmaceutical companies that introduce new drugs are currently granted five years of exclusive access to the clinical trial data they submit during the approval process. An extension of three years is available if new applications arise and a six month extension is granted if the drug is approved for use in pediatric populations.........

Posted by: Scott      Read more         Source


January 5, 2011, 7:01 AM CT

A new drug target in atherosclerosis

A new drug target in atherosclerosis
For decades, doctors have looked at fitness levels, weight, and overall health risk factors for heart disease and stroke. Now, they may soon add a new risk factor to the list: activation of the complement system. The complement system is commonly implicated in immune responses, but now there's a role for it in cardiovascular disease. In a new research report appearing in the January 2011 print issue of the FASEB Journal (http://www.fasebj.org), researchers from Europe and the United States show that anaphylatoxin C5a, a protein released when complement is activated, contributes to atherosclerotic disease. C5a causes plaques to break free from where they would be anchored to ultimately cause blockages elsewhere in the body. This new discovery not only shows that C5a is a new marker for identifying risk for heart attack and stroke, but it also establishes C5a as a new therapeutic target for preventing these problems.

"Given the huge impact of cardiovascular disease in general, and atherosclerosis in particular, on public health, we feel that unraveling mechanisms involved in the development and progression of the disease are of utmost importance," said Johann Wojta, Ph.D., a researcher involved in the work from the University of Vienna in Austria. "Our findings have identified a particular component possibly involved in the development of atherosclerosis as a target for future therapies".........

Posted by: Scott      Read more         Source


January 5, 2011, 6:46 AM CT

Metabolic cost of human sleep deprivation

Metabolic cost of human sleep deprivation
In the first-ever quantification of energy expended by humans during sleep, a University of Colorado team has observed that the metabolic cost of an adult missing one night of sleep is the equivalent of walking slightly less than two miles.

The new findings will help scientists further understand one of the important functions of sleep in humans, said CU-Boulder Associate Professor Kenneth Wright. Wright, who led the study, said the goal was to measure and quantify energy expenditure during both sleep and wakeful periods.

"We observed that people do expend more energy when they are awake in bed than when they are asleep," he said. The findings showed the eight hours of sleep saved roughly 135 calories over eight hours of wakefulness.

"While the amount of energy savings for humans during sleep may seem relatively small, it actually was a little more than we expected," said Wright, a faculty member in CU-Boulder's integrative physiology department and director of CU-Boulder's Sleep and Chronobiology Laboratory.

A paper on the subject was reported in the recent issue of the Journal of Physiology Co-authors included CU-Boulder's Christopher Jung and Emily Frydenall, as well as Assistant Professor Edward Melanson, Dr. Leigh Perreault and Dr. Robert Eckel of the University of Colorado School of Medicine. Jung, first author on the paper, got his doctorate from CU-Boulder in 2009 and is now at the University of Alaska.........

Posted by: Janet      Read more         Source


December 30, 2010, 6:33 AM CT

Protein involved in cystic fibrosis

Protein involved in cystic fibrosis
Principal investigator Neeraj Vij, Ph.D.

Credit: Johns Hopkins Children's Center

A team of Johns Hopkins Children's Center scientists has discovered that a protein involved in cystic fibrosis (CF) also regulates inflammation and cell death in emphysema and appears to be responsible for other chronic lung diseases.

The findings, published online in the recent issue of The Journal of Immunology, pave the way toward new therapys to prevent lung damage caused by infections or cigarette smoke in emphysema.

The protein, called CFTR (cystic fibrosis transmembrane conductance regulator), is already well known for its role in transporting chloride in and out of cells. In CF, the protein's chloride-carrying ability is absent due to genetic mutations, resulting in the buildup of thick sticky mucus in the lungs, which causes lung infections and breathing problems.

But the new Hopkins study indicates that CFTR is involved in immune regulation and immune response on a far wider scale. The research � conducted in mice and using lung tissue from people with and without emphysema � shows that those with lung damage from emphysema had less CFTR on the cell surface and that changes in the level of CFTR corresponded directly to disease severity. Decreases in CFTR also corresponded to increased buildup in the lung cells of a fatty molecule called ceramide, a well-known trigger of inflammation and cell death. Thus, the scientists say, by regulating ceramide's inflammation-causing activity, CFTR may be a watchdog for inflammation and cell death.........

Posted by: Scott      Read more         Source


December 30, 2010, 6:31 AM CT

Coma and general anesthesia

Coma and general anesthesia
The brain under general anesthesia isn't "asleep" as surgery patients are often told -- it is placed into a state that is a reversible coma, as per three neuroresearchers who have published an extensive review of general anesthesia, sleep and coma, in the Dec. 30 issue of the New England Journal (NEJM) This insight and others published in their review article could eventually lead to new approaches to general anesthesia and improved diagnosis and therapy for sleep abnormalities and emergence from coma.

The scientists explain that a fully anesthetized brain is much closer to the deeply unconscious low-brain activity seen in coma patients, than to a person asleep. Essentially, general anesthesia is a coma that is drug-induced, and, as a consequence, reversible. The states operate on different time scales -- general anesthesia in minutes to hours, and recovery from coma in hours to months to years, if ever. The study of emergence from general anesthesia and recovery from coma could help to better understand how both processes occur.

Understanding that these states have more in common with each other than differences -- that they represent a continuum of activity with common circuit mechanisms being engaged across the different processes of awakening from sleep or emerging from coma or general anesthesia -- "is very exciting, because it gives us new ways to understand each of these states," says co-author of study, Dr. Nicholas D. Schiff, a professor of neurology and neuroscience at Weill Cornell Medical College and a neurologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Co-authors of the study are Dr. Emery Brown of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard Medical School, and Dr. Ralph Lydic from the University of Michigan.........

Posted by: Scott      Read more         Source


December 29, 2010, 6:34 AM CT

Breathalyzers for medical diagnostics

Breathalyzers for medical diagnostics
This image shows a new type of sensor for an advanced breath-analysis technology that rapidly diagnoses patients by detecting "biomarkers" in a person's respiration in real time. Researchers used a template made of micron-size polymer particles and coated them with much smaller metal oxide nanoparticles. Using nanoparticle-coated microparticles instead of a flat surface allows researchers to increase the porosity of the sensor films, increasing the "active sensing surface area" to improve sensitivity. (Purdue University and NIST)

Scientists have overcome a fundamental obstacle in developing breath-analysis technology to rapidly diagnose patients by detecting chemical compounds called "biomarkers" in a person's respiration in real time.

The scientists demonstrated their approach is capable of rapidly detecting biomarkers in the parts per billion to parts per million range, at least 100 times better than prior breath-analysis technologies, said Carlos Martinez, an assistant professor of materials engineering at Purdue who is working with scientists at the National Institute of Standards and Technology.

"People have been working in this area for about 30 years but have not been able to detect low enough concentrations in real time," he said. "We solved that problem with the materials we developed, and we are now focusing on how to be very specific, how to distinguish particular biomarkers".

The technology works by detecting changes in electrical resistance or conductance as gases pass over sensors built on top of "microhotplates," tiny heating devices on electronic chips. Detecting biomarkers provides a record of a patient's health profile, indicating the possible presence of cancer and other diseases.

"We are talking about creating an inexpensive, rapid way of collecting diagnostic information about a patient," Martinez said. "It might say, 'there is a certain percentage that you are metabolizing a specific compound indicative of this type of cancer,' and then additional, more complex tests could be conducted to confirm the diagnosis."........

Posted by: Scott      Read more         Source


December 24, 2010, 1:29 PM CT

Fat cells become useful stem cells

Fat cells become useful stem cells
Two studies appearing in the current issue.

of Cell Transplantation 19(10) discuss stem cells derived from adipose (fat) cells and their potential use in plastic surgery and tissue reconstruction. The studies are now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

Adipose-derived stem cells maintain their "stemness" and could be useful for cell-based therapies.

A team of scientists from several institutions in Italy isolated and characterized adult fat cell-derived stem cells from patients undergoing lipoaspiration (surgical removal of fat deposits) in order to investigate the ability of the fat cells to maintain their stem cell characteristics in in vitro cultures to the point where once transplanted they could aid in tissue regeneration.

As per the study's corresponding authors Dr. Stefami Bucher of the San Gallicano Institute (Rome) and Dr. Rita Falcioni of the Regina Elena Cancer Institute (Rome), adipose tissues share several biological properties with bone marrow, they can be found in abundance, they can be obtained from patients undergoing noninvasive lipoaspirate procedures, and they have the potential to be useful in a range of therapeutic applications.

"The use of lipoaspirate as filling material is a powerful technique for tissue repair in plastic surgery," said Dr. Falcioni. "Increasingly, it is used in oncology to repair tissue damaged by surgical therapys, such as mastectomy. The use of purified adipose-derived stem cells might improve this surgical procedure by shortening the time to achieve esthetic results and thereby improving patient quality of life."........

Posted by: Scott      Read more         Source


December 16, 2010, 7:54 AM CT

Compound with potent effects on biological clock

Compound with potent effects on biological clock
Using an automated screening technique developed by pharmaceutical companies to find new drugs, a team of scientists from UC San Diego and three other research institutions has discovered a molecule with the most potent effects ever seen on the biological clock.

Dubbed by the researchers "longdaysin," for its ability to dramatically slow down the biological clock, the new compound and the application of their screening method to the discovery of other clock-shifting chemicals could pave the way for a host of new drugs to treat severe sleep disorders or quickly reset the biological clocks of jet-lagged travelers who regularly travel across multiple time zones.

Typically typically typically "theoretically, longdaysin or a compound like it could be used to correct sleep disorders such as the genetic disorder familial advanced sleep syndrome, which is characterized by a clock that's running too fast," said Steve Kay, dean of UCSD's Division of Biological Sciences, who headed the research team, which published its findings in the December 14 issue of the journal PLoS Biology "A compound that makes the clock slow down or speed up can also be used to phase-shift the clockin other words, to bump or reset the hands of the clock. This would help your body catch up when it is jet lagged or reset it to a normal day-night cycle when it has been thrown out of phase by shift work".........

Posted by: Scott      Read more         Source


December 9, 2010, 7:48 AM CT

Autism breakthrough

Autism breakthrough
Eastern Virginia Medical School scientists have identified a potential novel therapy strategy for the social impairment of people with Autism Spectrum Disorders (ASD), an aspect of the condition that has a profound impact on quality of life.

"Persons with Autism Spectrum Disorders are either disinterested in social interactions or find them unpleasant. They often don't understand what other people are thinking or feeling and misinterpret social cues," said Stephen I. Deutsch, MD, PhD, the Ann Robinson Chair and professor of psychiatry and behavioral sciences. "Sadly, persons with autism spectrum disorders are often painfully aware of their limited sociability, which can lead to profound feelings of sadness and frustration".

As part of their research, EVMS researchers verified that a specific mouse strain, known as the BALB/c mouse, is a valid animal model of the limited sociability seen in persons with ASD. In the presence of another mouse, BALB/c mice move as far away as possible and do not interact as normal mice do just like people with autism often avoid making social contact with other people.

This finding gave scientists a way to test whether an existing medicine can alter the function of certain receptors in the brain known to affect sociability and help the animals be more at ease around others. The medicine used, D-Cycloserine, originally was developed to treat tuberculosis, but prior studies showed, by chance, that it might change social behavior. In preliminary studies at EVMS, the medicine appeared to resolve the Balb/c mouse's deficits of sociability; it behaved as a normal mouse would when placed near another.........

Posted by: JoAnn      Read more         Source


December 9, 2010, 7:02 AM CT

Embryonic stem cell research

Embryonic stem cell research
States, not the federal government, now fund the majority of human embryonic stem cell research conducted in the United States, as per a recent study in the journal Nature Biotechnology In addition, states varied substantially in the extent to which they prioritized human embryonic stem cell research, and much of the research performed in the states could likely have been funded by the National Institutes of Health under federal guidelines established by President Bush in 2001.

"While the federal government still contributes more to stem cell research overall, each year since 2007 these six states have funded more human embryonic stem cell research than the federal government," said Aaron Levine, assistant professor at Georgia Tech.

Levine created an online searchable database (http://www.stemcellstates.net/) that allows users to find detailed information about each grant given out by the six states that adopted programs specifically to fund stem cell research. The database currently covers grants given out by California, Connecticut, Illinois, Maryland, New Jersey and New York from December 2005 to December 2009, and will be updated yearly with new information.

"From what I could tell, only a relatively small portion of the stem cell research supported by these states was clearly ineligible for federal funding," said Levine, who is on the faculty of the School of Public Policy in the Ivan Allen College of Liberal Arts.........

Posted by: Scott      Read more         Source



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Did you know?
Scientists at Yale have brought to light a mechanism that regulates the way an internal organelle, the Golgi apparatus, duplicates as cells prepare to divide, according to a report in Science Express.Graham Warren, professor of cell biology, and colleagues at Yale study Trypanosoma brucei, the parasite that causes Sleeping Sickness. Like a number of parasites, it is exceptionally streamlined and has only one of each internal organelle, making it ideal for studying processes of more complex organisms that have a number of copies in each cell.

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