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Archived News Headlines

We have been archiving all OBR daily news stories since March 2008. Use the box below to search our archives for specific articles and content.

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Approving a Problematic Muscular Dystrophy Drug

(JAMA) Oct 24, 2016 - In September 2016, the US Food and Drug Administration (FDA) approved eteplirsen (Exondys 51), a new drug for Duchenne muscular dystrophy (DMD), overruling the recommendations of both its scientific staff and its external advisory committee.
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Caris Life Sciences and Threshold Pharmaceuticals Collaborate to Utilize Caris’ ADAPT Biotargeting System in the Development Program for Evofosfamide

(Yahoo! Finance) Oct 25, 2016 - Caris Life Sciences, a leading biotechnology company focused on fulfilling the promise of precision medicine, and Threshold Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in the development of novel pharmaceutical products for the treatment of cancer, today announced that they have entered into a development and commercialization agreement to utilize Caris’ patented and proprietary ADAPT Biotargeting System™ to develop a tissue-based clinical diagnostic assay for pancreatic cancer patients to predict the likelihood of response to evofosfamide, Threshold’s lead drug candidate for the potential treatment of patients with cancer.
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CMS to Host Webinars on Final MACRA Rule

(ACCC) Oct 24, 2016 - The Centers for Medicare & Medicaid Services (CMS) is hosting a series of webinars on the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) final rule with comment period. These webinars will provide an overview of the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Model (APM) incentive payment provisions under MACRA, collectively referred to as the Quality Payment Program.
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Cancer Care: Is World Class Status a Distant Dream?

(BBC News) Oct 24, 2016 - Linear accelerators are wonderful machines. They deliver high-energy radiation to a tumour, helping to destroy cancer cells while sparing the normal tissue which surrounds them.
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ASCO Recommends Key Priorities for 21st Century Cures

(ASCO in Action) Oct 24, 2016 - ASCO sent a letter to leaders in the U.S. House of Representatives and the U.S. Senate applauding the bipartisan, bicameral work to advance the 21st Century Cures Act, and urging leaders to move the bill through final passage when Congress returns into session later this year.
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IBM CEO On Watson's Latest Answers For Fighting Cancer

(CBS News) Oct 24, 2016 - IBM CEO Ginni Rometty is convinced we are in the “third era of technology,” as IBM’s Watson Health partners with Quest Diagnostics to offer its cognitive computing technology nationwide for the first time.
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Agilent Technologies Receives Expanded FDA Approval for Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Non-Small Cell Lung Cancer (NSCLC)

(Agilent) Oct 24, 2016 - Agilent Technologies Inc. today announced that its Dako PD-L1 IHC 22C3 pharmDx now has an expanded label approved by the U.S. Food and Drug Administration for use in determining PD-L1 expression status to inform treatment in metastatic non-small cell lung cancer (NSCLC) with KEYTRUDA® (pembrolizumab).
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DINO RNA Molecule Triggers Anticancer Response in Damaged Cells

(NCI Cancer Currents Blog) Oct 24, 2016 - Researchers from Stanford University have identified an important molecule involved in the process that normally causes irreparably damaged cells to self-destruct.
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Cancer Risk Reduction in the Trenches: PCPs Respond

(Medscape Medical News) Oct 25, 2016 - Cancer is often cited as the disease most Americans fear, and the latest statistics from the National Cancer Institute show that it will affect more than 1 in 3 people (39%).
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Drug Target for Triple-Negative Breast Cancer Found in New Study

(UCSF Cancer Center) Oct 24, 2016 - A team of researchers led by UC San Francisco scientists has identified a new drug target for triple-negative breast cancer, an aggressive disease subtype that has the poorest outcomes and accounts for as many as one in five cases. The findings are particularly noteworthy because drugs that act on the newly discovered target, a protein known as PIM1, are already in clinical trials for leukemia and multiple myeloma.
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Ludwig Researchers Develop a New Way to Evaluate Aggressiveness of Bladder Cancer

(Ludwig Cancer Research) Oct 24, 2016 - A Ludwig Cancer Research study published in the current issue of Scientific Reports describes a new method and risk model to assess how aggressive a bladder cancer is likely to be. “If confirmed in larger studies, our findings could help physicians get a better handle on how a patient’s bladder cancer is likely to progress and allow them to personalize treatment on the basis of that knowledge,” said Ralph Weichselbaum, director of the Ludwig Center at the University of Chicago, who led the study.
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There’s an Easier Way to Screen for Colon Cancer

(TIME) Oct 24, 2016 - When it comes to colon cancer, the most popular strategy for screening is the colonoscopy, which involves a nearly 24-hour commitment to the prep for the invasive and uncomfortable procedure.
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New Results Presented for Opdivo (nivolumab) Demonstrate Encouraging Response Rate in an Expanded Population of Heavily Pre-Treated Classical Hodgkin Lymphoma Patients

(StreetInsider) Oct 25, 2016 - Bristol-Myers Squibb Company today announced new results from CheckMate -205, a multi-cohort, single-arm, Phase 2 trial evaluating Opdivo (nivolumab) in patients with classical Hodgkin lymphoma (cHL).
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Opinion: 'More Is Not Necessarily Better': Discontinuing Immunotherapy in NSCLC

(Medscape Medical News) Oct 24, 2016 - Both oncologists and cancer patients have become enamored of the potential of PD-1- and PD-L1-directed immune checkpoint inhibitors to lead to dramatic and prolonged responses in patients with advanced non–small cell lung cancer as well as many other malignancies.
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One-Fourth of US Cancer Deaths Linked With 1 Thing: Smoking

(New York Times) Oct 24, 2016 - Cigarettes contribute to more than 1 in 4 cancer deaths in the U.S. The rate is highest among men in Southern states where smoking is more common and the rules against it are not as strict.
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Merck Wins Early U.S. Approval for Keytruda in Untreated Lung Cancer

(Reuters) Oct 25, 2016 - Merck & Co has won U.S. approval to market its immunotherapy Keytruda for use in previously untreated lung cancer patients two months ahead of schedule, making it the only such drug cleared for first-line treatment.
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Type 1 Diabetes Often Comes with Other Autoimmune Diseases

(Reuters Health) Oct 21, 2016 - People with type 1 diabetes often develop other autoimmune disorders, such as thyroid and gastrointestinal diseases, and a recent study yields new information about this link.
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EpiPen Shows A Path To Solve The Bigger Drug Pricing Challenge

(Forbes) Oct 24, 2016 - Scrutiny of the high list price of the drug EpiPen, used for the emergency treatment of certain allergic reactions, exposed some of the craziness and inefficiency in how drugs are priced. But it also reveals problems with how certain medicines are developed.
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Why the U.S. Still Trails Many Wealthy Nations in Access to Care

(New York Times/Upshot blog) Oct 24, 2016 - Many are still unhappy with Obamacare.
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Researchers Take First Steps Toward A Preventative Alzheimer's Pill

(Forbes) Oct 24, 2016 - A preventative Alzheimer’s pill is the ideal end game for researchers studying the disease from many angles. While we’re not yet close to the goal, new research shows a way that it may be possible, using an approach similar to what has worked for managing other chronic conditions.
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GSK Files Potential $1 Billion Shingles Vaccine for U.S. Approval

(Reuters) Oct 24, 2016 - GlaxoSmithKline has filed its shingles vaccine Shingrix for U.S. regulatory approval, the drugmaker said on Monday, bringing the potential $1 billion-a-year seller a step closer to market.
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Aduro Biotech Stock Drops as Much as 22% After Patient Tested Positive for Listeria

(MarketWatch) Oct 24, 2016 - Aduro Biotech Inc. shares plummeted as much as 22% in premarket trade Monday after the company said a patient tested positive for listeria, prompting the Food and Drug Administration to place its clinical trials on partial clinical hold. The hold is directed at Aduro's listeria-based immunotherapy construct platform and will pause new patient enrollment, though nearly all current patients will continue to receive treatment, the company said
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Inovio Announces FDA Request for Additional Information For Phase III Program; Trial Initiation Delayed

(Yahoo! Finance) Oct 24, 2016 - Inovio Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its proposed phase III clinical program for VGX-3100. A clinical hold is a notification issued by the FDA to a trial sponsor to delay a proposed clinical trial or suspend an ongoing clinical trial. This study has not yet been initiated and has not enrolled or dosed subjects. Additionally, the hold does not pertain to any of Inovio’s other ongoing clinical studies.
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Bristol-Myers Squibb’s Coast 2 Coast 4 Cancer Ride Raises Over $1 Million for Cancer Research

(BMS) Oct 24, 2016 - Bristol-Myers Squibb’s Coast 2 Coast 4 Cancer has raised more than $1,050,000 to support Stand Up To Cancer’s collaborative cancer research programs. In this third year of the relay, six teams of BMS employees -- with 80 employees in total -- set out on September 7 to bike 2,800 miles in 21 days from the Oregon Coast to the New Jersey shore to support Stand Up To Cancer, whose collaborative “Dream Teams” of scientific researchers are working together to accelerate cancer research and to provide innovative treatments to patients faster. Bristol-Myers Squibb matched all money raised by the cyclists, dollar-for-dollar, up to $500,000.
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Stage IV Cancer: Seizing The Chance For a Clinical Trial

(Philadelphia Inquirer/Health blog) Oct 24, 2016 - A big part of Stage IV cancer life is “seize the day” or “carpe diem” in the original Latin.
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