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Ensuring the Safety and Commercial Success of Biosimilars in the United States

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The forthcoming arrival of biosimilars into the U.S has spurred debate over the approaches that the FDA and industry should take to ensure patient safety while promoting market competition and continued biomedical innovation. During a presentation Tuesday at the 2014 BIO International Convention, participants at this Super Session focused on the need for prescribing physicians and providers to closely partners with one another to ensure that safety and efficacy are the priorities in the debate Read More >

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Fighting Prostate Cancer with Immunotherapy

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Advaxis and UC San Francisco join forces to develop and test a range of novel constructs Prostate cancer is the second leading cause of cancer death in American men, behind lung cancer. According to the American Cancer Society, around 230,000 new cases of prostate cancer are diagnosed and 30,000 men die from the disease each year. Cancer immunotherapy offers one promising approach to combating the disease. The University of California, San Francisco, (UCSF) and biotechnology Read More >

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RSV Vaccines

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Respiratory syncytial virus (RSV) is a major pathogen in infants, children, and adults. According to the Centers for Disease Control and Prevention (CDC), RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the U.S., and is now recognized as a major cause of respiratory illness in adults 65 and older. The global disease burden is estimated at 64 Read More >

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Differences Between Establishing Value for Approval Versus Coverage?

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Yes, but maybe not irreconcilable. Many of the educational sessions on the first day of the 2014 BIO International Convention touched on one essential question: how can safe and effective treatments get to the patients who need them faster? Panelists in the session Irreconcilable Differences? A Balanced Approach to Establishing Value approached this key question through a discussion of how to shorten the time between—and improve the predictability and expectations around—regulatory approval and coverage and Read More >

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Sir Richard Branson Inspires Crowd Cuts Up with Jim Greenwood

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Though Sir Richard Branson clowned from the get-go, BIO CEO Jim Greenwood earned the first great laugh from the BIO 2014 keynote luncheon audience. Having detailed Branson’s swashbuckling entrepreneurship style (more than 400 companies under his Virgin umbrella), as well as adventures attempting world-firsts crossing oceans in boats and balloons, he asked his keynote guest why he’d never started a biotech firm: “Just never had the guts, huh?” challenged Greenwood. Famous for starting a successful Read More >

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