New tests promise to make prostate cancer diagnosis more accurate | Oncologists' group develops evidence-based decision tool | PatientsLikeMe expands clinical trial matching tool
March 28, 2013
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European Medicines Agency demands clinical trial transparency
The European Union's counterpart to the FDA, the European Medicines Agency, is creating a policy that would require drugmakers to publish some clinical trial data for drugs submitted for approval. Stakeholders in the U.K. are set to meet next month to further discuss the challenges of data openness. Nature (free content)/News blog (3/27)
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Science and Technology
New tests promise to make prostate cancer diagnosis more accurate
Tests being developed for prostate cancer could provide more accurate diagnosis than the prostate-specific antigen test now in use, reducing unnecessary treatment, spending and angst. However, a flood of new tests could cause confusion at first regarding which test is best for any specific patient and how insurance will reimburse, says Jan Manarite with the Prostate Cancer Research Institute. The New York Times (free-article access for SmartBrief readers) (3/26)
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Oncologists' group develops evidence-based decision tool
The American Society of Clinical Oncology is launching a prototype tool to analyze patient health records, treatments and outcomes that clinicians can consult before deciding a course of treatment. The CancerLinQ network already has information on more than 130,000 patients. MedPage Today (free registration) (3/27), The Wall Street Journal (tiered subscription model) (3/26)
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PatientsLikeMe expands clinical trial matching tool
PatientsLikeMe is expanding its free tool that matches patients with clinical trials based on patients' conditions and locations. The tool will now be available worldwide. PharmaTimes (U.K.) (3/26)
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Gene discoveries open treatment targets for 2 blood disorders
An international team of researchers says the discovery of two genetic mutations has yielded the possibility of new ways to treat beta-thalassemia and hemochromatosis. Blocking the macrophages that attach to erythroblasts could reduce red blood cell production, and changing the Tmprss6 gene could halt the body's use of iron. The findings were published in Nature Medicine and the Journal of Clinical Investigation. (3/26)
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"Small data" crucial for pharma in making business decisions
The most important data challenge facing the pharmaceutical industry is the diversity of information necessary to make decisions at all points, writes Lee Feigenbaum of Cambridge Semantics, from discovery to development and commercialization. Relevant information can come from a wide range of sources and include both structured data, unstructured data and everything in between. While the necessary information may be "small data," its use is critical in making business decisions, Feigenbaum writes. FierceBiotechIT (3/27)
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Finance and Economics
Booz: Pharma should take individual approach to emerging markets
A new analysis from consultant Booz & Co. notes that emerging markets may not be as lucrative for pharmaceutical companies as they hope. While pharma companies that enter these markets early can help shape them, the report noted that the size of countries classified as "emerging markets" varies, and the "ambitious targets" of some companies have not be met. "Companies should be aware that whilst there is huge potential here, variations within the emerging markets themselves require different and tailored approaches," the report cautions. PharmaTimes (U.K.) (3/28)
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Approval of Biogen's MS drug offers hope
The FDA approved Biogen Idec's new oral drug for multiple sclerosis, Tecfidera (dimethyl fumarate), giving patients a welcome alternative to injected drugs. It was shown to lessen the number of flare-ups of the disease over a two-year period in two clinical trials involved 2,600 patients, and investors anticipate the new drug will become a top seller for treating MS. Xconomy/Boston (3/27)
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Biologics, SCOTUS' take on patent settlements boost Big Pharma
Supreme Court justices expressed skepticism that patent settlements between brand-name and generic-drug makers should be unilaterally declared anti-competitive, writes Bruce Japsen. Generic drugs have cut into profits as Big Pharma has struggled to fill pipelines, and the news boosted stock values. Big Pharma is increasingly focused on developing complex biologic drugs to treat diseases such as cancer, multiple sclerosis and autoimmune disorders. Forbes (3/27)
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Society and Ethics
Scientists fret over patented genes
Patents on short DNA sequences, aggregated together, cover the entire human genome, and patents on long sequences cover 41% of the human genome, researchers write in Genome Medicine. Enforcement of the patents could impede research and development of new drugs and diagnostics, the researchers said. Genetic Engineering & Biotechnology News (3/27)
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