Bristol-Myers Squibb (BMY)’s Miracle Drug Opdivo Receives Yet Another Breakthrough Designation
Bristol-Myers Squibb (BMY)’s Miracle Drug Opdivo Receives Yet Another Breakthrough Designation Article taken from: http://www.biospace.com/News/bristol-myers-squibbs-miracle-drug-opdivo-receives/424509?intcid=homepage-seekercarousel-featurednews-navindex4 Image source: http://www.webmd.com/cancer/bladder-cancer/ Princeton, New Jersey – Bristol-Myers Squibb (BMY) announced today that its drug Opdivo had been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-based chemotherapy regimen. Bladder cancer is the ninth most commonly diagnosed cancer worldwide. There are about 430,000 new cases diagnosed each year with over 165,000 deaths annually. Urothelial carcinoma is the most common type of bladder cancer, responsible for about 90 percent of all cases. They are typically diagnosed early, but recurrence and progression is common, with about 78 percent of patients having recurrence within five years. Patients with Stage IV bladder cancer have a five-year survival rate of 15 percent. Opdivo has received Breakthrough Therapy Designations for a number of indications, including previously treated recurrent or metastatic squamous cell carcinoma of the head and neck, Hodgkin lymphoma after autologous stem cell transplant and brentuximab-vedotin failed, for previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer, and previously treated advanced or metastatic renal cell carcinoma. Opdivo is one of the newest types of cancer treatments, an immuno-oncology compound. Opdivo is a PD-1 immune checkpoint inhibitor. It binds to the checkpoint receptor PD-1, which is expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2, which prevents the PD-1 pathway’s suppressive signaling on the immune system. In other words, cancer cells generate molecules that allow them to hide from the immune system. Opdivo acts by preventing cancer cells from hiding. “Urothelial cancer is a common type of bladder cancer where patients experience high rates of recurrence and remains an area where new treatment approaches are needed, further underscoring the importance of this designation for Opdivo,” said Jean Viallet, Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, in a statement. “As part of our commitment to bring Opdivo to these advanced bladder cancer patients as quickly as possible, we look forward to filing a marketing application with health authorities based on results from study -275 and other supporting data in the coming months, as well as submitting the data for presentation at an upcoming medical meeting.” On May 11, the European Commission approved the first and only immuno-oncology combination, Opdivo and Bristol-Myers Squibb’s Yervoy. It was approved for the treatment of advanced unresectable or metastatic melanoma in adults. “Historically, advanced melanoma has been a very difficult-to-treat disease,” said James Larking, lead author on Checkmate – 067, from The Royal Marsden, in a statement. “Now, with this approval, patients in Europe will have a treatment option combining two Immuno-Oncology therapies, Opdivo and Yervoy, which in a Phase III randomized trial has shown its ability to deliver superior efficacy versus Yervoy monotherapy in progression-free survival and response. This is truly good news for healthcare providers and the patients they treat, as it represents an important new treatment option with the potential for improved outcomes.” Opdivo works by taking the brake off the immune system. Yervoy stimulates the immune system. In combination, it’s like simultaneously taking your foot off the brake and stomping on the gas. Although the side effects are potentially severe, the immuno-oncology combinations are showing a great deal of promise. Source: http://www.biospace.com/News/bristol-myers-squibbs-miracle-drug-opdivo-receives/424509?intcid=homepage-seekercarousel-featurednews-navindex4 Date: June 27th. 2016
FOMAT at the DIA
FOMAT at the DIA Join FOMAT Medical Research at the DIA event in Philadelphia, we will be present from the 26th through the 30th of June. Our company specializes in conducting Clinical Trials at Our Sites throughout the Americas as well as being your local CRO. The Drug Information Association was created 52 years ago for the soul purpose of gathering experienced healthcare and drug development professionals from the pharmaceutical industry and other related fields into one location. The DIA event encourages and simplifies communication and cooperation between the medical professionals in this honored community. By providing a place to congregate, cutting-edge pharmaceutical and healthcare information is available to the entire medical field. DIA is one of the largest conferences worldwide, reaching more than seven thousand reputable professionals this year. This non-profit organization serves as the ideal environment for our company, FOMAT Medical Research, to show the pharmaceutical world the company´s view, leadership, and potential as a strong CRO & SMO. Furthermore, this allows us to promote clinical research for Hispanics in Latin America, an area in which research is exponentially growing due to enormous benefits, such as short regulatory time, rapid compliant patient recruitment, and access to a large drug-naive patient population with common and special disease profiles. We encourage you to visit us at booth #1056 and meet our Managing Director Nicholas Focil alongside our Project Coordinator Colton Gomez. It´ll be an interactive presentation full of games, rewards, and environmentally-friendly initiatives, which present a new approach for all people working in the pharmaceutical industry. FOMAT is truly convinced that this DIA event will provide the medical world with useful up-to-date information, and serve as a link for all the different companies that work in the pharmaceutical area. This is the perfect opportunity for us to learn from each other, and build strong networks and lasting relationships. Written by: Santiago Focil Date: June 24th. 2016
Scientists Discover How West Nile Triggers Memory Loss
Scientists Discover How West Nile Triggers Memory Loss Article taken from: http://www.dddmag.com/news/2016/06/scientists-discover-how-west-nile-triggers-memory-loss Image Source: http://www.dddmag.com/news/2016/06/scientists-discover-how-west-nile-triggers-memory-loss Researchers at the University of Colorado Anschutz Medical Campus have discovered how the most severe forms of West Nile virus cause memory loss and mood disorders, opening the door to potential new treatments for the mosquito-borne illness. The study, published in the journal Nature, said 50 percent of patients who survive the most damaging kind of West Nile infection often go on to develop memory loss, learning difficulties, a lack of concentration and irritability. Exactly why this happens has been a mystery until now. Researchers discovered that the virus doesn’t kill off neurons but sparks inflammation that prunes synapses, the connections that carry messages between nerve cells. “What we found in mice, and later confirmed in humans, is that it’s not the death of cells that causes memory loss, it’s the loss of nerve cell connections,” said study co-author Kenneth Tyler, MD, chairman of the department of neurology at the University of Colorado School of Medicine. “The viral infection activates microglial cells and complement pathways which are helping to fight the infection but in turn end up destroying synapses.” Bette K. DeMasters, MD, professor and head of neuropathology at CU Anschutz, also co-authored the study. The researchers found that mice infected with West Nile had a difficult time negotiating their way out of a maze that healthy mice figured out much faster. They later discovered that the infected mice suffered significant damage to their synapses. The scientists examined brain tissue from humans who had died from West Nile and found the same phenomenon. Tyler said West Nile is the leading cause of acute viral encephalitis in the U.S. though still relatively rare. Only about one in 100 people infected with the disease develop the most severe form, he said. West Nile appeared in the U.S. during the late 1990s and has remained a persistent threat. Last year, California had 730 cases, Texas 252 cases and Colorado 101 cases. In Colorado, that number included 57 neuro-invasive cases, the most serious kind, and two deaths. “This discovery opens up the opportunity to test therapies and medications on mice as a precursor to humans,” Tyler said. “We already have some drugs that might be good candidates for treating this condition.” The best way to avoid West Nile is to wear long sleeves, use mosquito repellant and steer clear of standing water. The mosquito that carries the virus is most active at dusk and dawn. Source: http://www.dddmag.com/news/2016/06/scientists-discover-how-west-nile-triggers-memory-loss Date: June 24th. 2016
English speaking staff
Physicians, management teams, investigators, and clinical coordinators are fluent in English.
With over four million patients being seen by our hospitals each year and with relatively little to no clinical research exposure, our network is ideal for medical trials.