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By Alan, on January 27th, 2012
 Cross-section of kidney (National Library of Medicine) The Food and Drug Administration today approved the drug axitinib to treat patients with renal cell carcinoma, a form of advanced kidney cancer, who have not responded to another drug for this type of cancer. The drug is made by Pfizer Inc. in New York and marketed under the brand name Inlyta.
Renal cell carcinoma is the most common form of kidney cancer, which starts in the lining of very small tubes in the kidney. Inlyta works by blocking proteins called kinases that play a role in tumor growth and cancer progression. The drug is taken in pill form twice a day.
Inlyta was tested in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study measured progression-free survival, the time a patient lives without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with sorafenib, a standard treatment.
FDA reports the most common side effects found in more than one in five patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia), and constipation.
The agency advises that patients with high blood pressure should have it well-controlled before taking Inlyta. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal.
Read more: Candidate Drug Starves Cancer Cells of Energy Source
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By Alan, on January 27th, 2012
 Central Square subway station, Cambridge, Mass. The Experiment Fund, a joint venture of Harvard University’s engineering school and venture capital company New Enterprise Associates (NEA), opened today in Cambridge, Massachusetts. The fund plans to support technology-based student start-ups in Cambridge and companies begun elsewhere by former students.
The venture expects to support companies working in information technologies, health care, and energy. NEA’s Patrick Chung, one of Experiment Fund’s founders, expects the fund to support several promising companies over the next two years, with each new company receiving up to $250,000 in capital.
Cherry Murray, Dean of the Harvard School of Engineering and Applied Sciences says the fund “will provide a much needed set of people, skills, and financial resources to spur the innovation and idea creation of our students.” Murray says the school will designate faculty to advise student entrepreneurs about the fund and other local resources.
In November, Harvard opened its Innovation Lab at a satellite campus across the Charles River in Boston, to encourage entrepreneurial activities by students and faculty. The i-Lab, as it’s called, aims to bring together entrepreneurs from the local community, as well as encourage innovation across Harvard’s schools and academic disciplines.
Read more: Harvard Entrepreneur Center Opens
Photo: Bart Howard Everts/Flickr
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By Alan, on January 27th, 2012
 Columbia University in New York and the Wallace H. Coulter Foundation in Miami will establish the Columbia-Coulter Translational Research Partnership, part of a network of biomedical engineering and translational research institutions in the U.S. The program is expected devote $5 million in funding over five years, with two-thirds of the funds from the Coulter Foundation, and one-third from Columbia.
The Columbia program will operate from the biomedical engineering department in the university’s School of Engineering and Applied Science. The funds will go to biomedical technology projects deemed to have the best chance of achieving commercial success, which the foundation defines as a license of the technology to a commercial partner with the resources and expertise to bring the technology to market.
The Columbia projects are expected to focus on medical devices, diagnostics, and health care information technology. The foundation says it has funded more than 200 such projects at 10 universities. Of those 200 projects, 24 have resulted in licenses to established industrial partners, and 28 projects have served as the basis for start-up companies. Those companies have raised, says the foundation, some $150 million in investment capital and several hundred million dollars in governmental funding.
Columbia is among six universities in the second round of Coulter Foundation Translational Partnership Awards. The other schools are Johns Hopkins University in Baltimore, University of Louisville, University of Missouri, University of Pittsburgh, and University of Southern California in Los Angeles.
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Photo: Beraldo Leal/Flickr
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By Alan, on January 27th, 2012
 Vibration-powered sensor (Purdue University) Engineers at Purdue University in Indiana have developed a miniature medical sensor that can be powered by vibrations from music played nearby, with the deep bass of rap music found most effective. The research conducted in the lab of Babak Ziaie, professor of electrical and computer engineering and biomedical engineering, will be presented at the IEEE MEMS (microelectromechanical system) conference on 30 January. A patent has been filed for the device as well.
The miniature sensor (pictured right) is designed to be implanted in the body and measure blood pressure or pressure of urine in the bladder. Inside the sensor, a vibrating cantilever is a thin beam attached at one end like a miniature diving board. Music within a frequency range of 200-500 hertz causes the cantilever to vibrate, generating electricity and storing a charge in a capacitor. “The acoustic energy from the music can pass through body tissue, causing the cantilever to vibrate,” says Ziaie.
Vibrations reaching that range would likely be intermittent, thus when the frequency falls outside of the proper range, the cantilever stops vibrating, automatically sending an electrical charge to the sensor. The device then takes a pressure reading and transmits data as radio signals. If music is used to generate the vibrations, the constantly changing frequency of the music allows the sensor to to repeatedly alternate intervals of storing charge and transmitting data.
The sensor is about 2 centimeters long. Its cantilever beam is made from a ceramic material called lead zirconate titanate, a material that generates electricity when compressed. A receiver that picks up the data from the sensor could be placed several inches from the patient.
Ziaie’s team tested the sensor — now in an early prototype — in a water-filled balloon with plain audio tones and different types of music. Plain audio tones provided the frequencies needed to induce the powering vibrations, but they would likely be less pleasant, if not plain annoying, to patients than music.
Researchers experimented with four types of music: rap, blues, jazz and rock. “Rap is the best because it contains a lot of low frequency sound, notably the bass,” says Ziaie.
The researchers believe the device could be used diagnose incontinence. Current diagnostics call for inserting a probe with a catheter, which must be in place for several hours while the patient remains at the hospital. “A wireless implantable device could be inserted and left in place,” Ziaie notes, “allowing the patient to go home while the pressure is monitored.”
Read more: Driver Health Monitors Developed for Passenger Cars
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By Alan, on January 26th, 2012
 NIH’s National Heart, Lung, and Blood Institute has begun two clinical trials to evaluate treatments for out-of-hospital cardiac arrest:
- A comparison of continuous chest compressions (CCC) combined with pause-free rescue breathing, to standard cardiopulmonary resuscitation (CPR) that includes a combination of chest compressions and pauses for rescue breathing, and
- Treatment with the drug amiodarone, another drug called lidocaine, or a placebo in participants with shock-resistant ventricular fibrillation, a condition in which the heart beats chaotically instead of pumping blood.
University of Washington in Seattle will coordinate both trials. The studies are expected to include medical centers in Birmingham in Alabama, Portland in Oregon, San Diego, Pittsburgh, Dallas, Seattle, and Milwaukee. Canadian institutions taking part include those in Ottawa and Toronto in Ontario and Vancouver, B.C.
During a cardiac arrest, the heart stops beating, and unless it is restarted within minutes, the person usually dies. The majority of the approximately 350,000 people who have cardiac arrest in the United States each year are assessed by emergency medical service providers. Nonetheless, more than 90 percent of people who experience a cardiac arrest outside of a hospital die before reaching a hospital or soon thereafter.
The CCC trial will enroll 23,600 participants in eight cities and compare survival-to-hospital-discharge rates for two CPR approaches delivered by paramedics and fire fighters. Trained emergency personnel will give all participants in the CCC trial three cycles of CPR followed by heart rhythm analysis and, if needed, an electrical shock (defibrillation), applied to the chest. Half will be randomly assigned to receive continuous compressions combined with pause-free rescue breathing and half will receive standard professional CPR.
Standard CPR that includes chest compressions with short pauses for assisted breathing has been called into question by emerging data suggesting that stopping chest compressions to provide assisted breathing interrupts overall blood flow, thereby lowering survival.
The Amiodarone, Lidocaine, or Placebo Study (ALPS) will enroll up to 3,000 participants at nine locations across the U.S. and Canada. The trial determine whether amiodarone or lidocaine improves survival-to-hospital-discharge rates for participants with shock-resistant ventricular fibrillation. Participants will receive one or the other drug or a placebo.
About a quarter of cardiac arrests are due to ventricular fibrillation, a severely abnormal heart rhythm or arrhythmia. When shock treatment with a defibrillator fails to restore normal heart rhythm during ventricular fibrillation, medications such as amiodarone or lidocaine are often given, but their effectiveness in improving survival is unknown.
Read more: iPhone App Helps Doctors Deal with Cardiac Emergencies
Photo: Michael Gil/Flickr
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By Alan, on January 26th, 2012
 (Michigan.gov) Janssen Healthcare Innovation, a unit of pharmaceutical company Johnson & Johnson in San Diego, is offering a challenge with a total of $250,000 in awards for technology solutions to improve the care for patients discharged from the hospital. The Janssen Connected Care Challenge was announced today by Kimberly Park, a Janssen Healthcare Innovation partner, at the Care Innovations Summit, a conference in Washington, D.C.
Janssen says the challenge is designed to spur innovations for achieving better care and health at lower cost through continuous improvement, in this case on solutions to improve the coordination of care as patients are discharged after surgery or other inpatient stays. One in three patients aged 21 and older, discharged from a hospital to the community, says Janssen, does not see a doctor within 30 days of discharge. These patients are at the highest risk of being readmitted to the hospital.
The lack of coordinated post-hospital care increases the likelihood of readmission, which is a big driver of health care costs. While readmissions are a problem for all payers, the estimate for Medicare is that readmissions cost $15 billion a year, and $12 billion of these readmissions are considered preventable.
One contributor to high readmissions is believed to be a lack of communication and coordination among the patient, care giver, primary care doctor, and hospital’s physicians. Janssen says it is particularly interested in technology-based ideas to improve information sharing between hospitals, patients, care givers, and community-based doctors as a way to target this communication and coordination gap.
Ideas can be submitted between 27 February and 25 March 2012. Participants must be residents of the U.S. Submissions must consist of a text description and a visual supplement, such as a diagram or screen shot. The text part of the submission should include a description of the idea, a statement of benefit, and a business model showing its scalability and viability at minimal cost. Prototypes are not required for the initial submission, but finalists may be asked to prepare a prototype.
Three finalists will be asked to describe their solutions in detail before a panel of judges in May 2012, in a live, Webcast session. The winner will be announced on 23 May. The three finalists will each take home a $50,000 prize, and the overall winner will receive a $100,000 award.
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By Alan, on January 26th, 2012
 Influenza ultrastructure illustration (Dan Higgins, CDC) Researchers at the RIKEN Omics Science Center in Yokohama, Japan have developed a new technique to identify influenza virus infection in only 40 minutes and with 100 times the sensitivity of conventional methods. The findings from the team led by RIKEN Omics’ Toshihisa Ishikawa appear in the online journal PLoS ONE.
Ishikawa and his colleagues conducted the research and developed the technique in 2009 and 2010 to come up with better ways of diagnosing pandemic flu. The 2009 pandemic influenza A(H1N1) virus spread quickly around the world, resulting in some 18,000 deaths. In Japan, the virus affected no less than 16 percent of the population.
The technique, called the RT-SmartAmp assay, detects the virus from patient swab samples. The researchers succeeded in combining tests of two genomic indicators — reverse transcriptase and isothermal DNA amplification reactions — in one step. This achievement also did away with the need for separate RNA extractions and polymerase chain reactions. Adding a fluorescent primer enabled the team to detect in about 40 minutes the hemagglutinin (HA) gene in the virus, which a RIKEN Omics team had analyzed in an earlier study.
The researchers tested the RT-SmartAmp method in clinical research at clinics and hospitals in Tokyo and Chiba, Japan from October 2009 to January 2010, where the new technique outperformed standard diagnosis tests in both speed and sensitivity. Of 255 clinical samples, more than half (140 or 55%) were identified as 2009 pandemic A(H1N1)-positive by RT-SmartAmp, compared to less than half (110 or 43%) detected by standard diagnostics. In nearly three-quarters (73%) of all 140 infection-positive cases, the RT-SmartAmp assay detected the presence of the pandemic influenza virus within 24 hours of fever onset.
Read more: National Lab, University to Certify Flu Screening Machine
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By Alan, on January 26th, 2012
 (USTR.gov) The pharmaceutical company Celgene Corp. in Summit, New Jersey says it will acquire Avila Therapeutics, a biotechnology company in Bedford, Massachusetts. Celgene discovers and commercializes therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Avila develops covalent drugs, those that bind to and inhibit disease-causing proteins.
Under the agreement, Celgene will acquire Avila for $350 million in cash, plus up to $575 million in milestone payments. Most ($380 million) of the milestone payments are conditioned on development of drug candidates from Avila’s Avilomics platform. That platform, says the company, is based on a chemistry process that forms selective rather an indiscriminate bindings, informatics to target potential binding sites, and empirical testing at target and proteomic levels.
The remaining $195 million in milestones are based on the development and regulatory approval of Avila’s drug candidate AVL-292, a covalent drug for the treatment of hematologic cancers such as non-Hodgkin’s lymphoma and B-cell chronic lymphocytic leukemia, and autoimmune diseases such as rheumatoid arthritis. Avila says AVL-292 showed evidence of effectiveness in preclinical tests on animals, is has successfully completed two phase 1 clinical trials.
Celgene expects the Avila acquisition to be completed during the first quarter of 2012. The company does not anticipate the acquisition to affect its 2012 earnings guidance.
Read more: Biotech Lands $30 Million Late Stage Investment
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By Alan, on January 25th, 2012
 (Agricultural Research Service, USDA) Researchers at three universities, the Donald Danforth Plant Science Center, and USDA’s Agricultural Research Service have received a $1.3 million grant from National Science Foundation for research on reducing the amount of fertilizer to grow maize. The three-year project is led by the ARS’s Ivan Baxter, who also serves on the Danforth Center’s faculty in St. Louis. Other team members represent Cornell University, Purdue University, and University of Minnesota.
Maize is one of the most widely grown crops worldwide and has been adapted to many different growing conditions, resulting from a high degree of genetic and phenotypic diversity. While some aspects of this diversity have been studied, less is known about adaption to soil conditions, which the research under the grant is expected to address.
The goal of the project is to use the knowledge generated by the research to produce a more nutritious crop that can grow in more environments while using less fertilizer, and thus reduce the strain on the environment. The researchers plan to use a statistical analytic technique called Nested Association Mapping designed to describe the genetic architecture of traits in corn.
The team anticipates using this tool to identify the way different genes interact with mineral nutrients and toxic elements from various soil conditions to better understand soil’s role in the state of maize. The research is expected to create hypotheses that can be tested using experimental varieties evaluated across the United States and in Africa.
In addition to the research, the grant supports training opportunities for young scientists, aspiring scientists, teachers, and international scientists. Student and teacher internships will be sponsored in St. Louis, St. Paul, Minnesota and Ithaca, New York, while educational resources will be developed to help high school teachers add bioinformatics and plant molecular biology to their curricula.
Read more: Grant Funds Research on Developing Corn for Warmer Climate
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By Alan, on January 25th, 2012
 Carlos Varela (Rensselaer Polytechnic Institute) A grant from the U.S. Air Force to Rensselaer Polytechnic Institute in Troy, New York will fund development of computer logic to help create safer and more efficient flight technology. The $100,00 grant was awarded to computer scientist Carlos Varela of Rensselaer’s Data Science Research Center, who is also a licensed pilot (pictured right).
Varela’s project will devise programming logic to help pilots process the constant stream of data from air traffic controllers, weather reports, and the multiple sensors throughout the aircraft. Problems can occur, however, when the dynamic decision-making needs of the pilot rely on static data sources, such as weather forecasts, that may be out of date or even incorrect. “Data should drive the flight systems in an aircraft to create active and constantly updated flight data for the pilot,” says Varela.
According to Varela, data must understand the connections with other data. A pilot or autopilot system cannot take the right action when the data they are receiving are out of date or wrong. This may have been the problem with the crash of Air France flight 447, says Varela, which crashed into the Atlantic in June 2009 killing, all on board.
Evidence from the crash suggests that the pilots on board raised the nose of the plane when it shouldn’t have been brought up, based on erroneous readings from the autopilot caused by equipment failure. Varela himself experienced a somewhat similar problem, when ice on an air speed sensor caused it to fail. Fortunately, says Varela, he had GPS readings that gave him an estimate of ground speed — providing a rough indicator of air speed — until he could deice the sensor and resume accurate air speed readings, which enabled him to safely finish the flight.
These experiences led Varela to develop new programming logic that reduces the possibility of accidents by making connections between the different data streams available to a pilot. This method creates redundancies in the data that allow the different data streams to serve as reality checks on each other. The use of ground speed to estimate air speed, as shown in Varela’s experience, is one example. Another example is flight plans based on weather and air traffic forecasts, which may be obsolete by the time of the flight.
The system Varela seeks to develop would allow for the easier and faster inclusion of new data. This kind of system would react to new data from sensors indicating changes in air pressure or temperature that would trigger dependencies with other data, such as data from the sensors that detect dangerous icing on the wings.
The new system is expected build on the current state of logic programming in computer science by extending a logic programming language to associate probabilities to other knowledge. “The programming will model the data mathematically,” says Varella, “so a pilot can tell that the data being received is wrong with some probability and have more information to make a flight decision.”
Read more: Algorithm Being Developed to Limit Small Airplane Collisions
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