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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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Principles on Clinical Trial Data Sharing Reaffirm Commitment

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BIO member companies will honor, at minimum, the following commitments: REGISTERING CLINICAL TRIALS: BIO member companies will register all company-sponsored clinical trials conducted in patients in an appropriate public registry, such as ClinicalTrials.gov or the European Clinical Trials Database (EudraCT). SUMMARIZING THE RESULTS OF CLINICAL TRIALS: BIO member companies will post technical summary results in a clinical trials database as follows: For approved products, all company sponsored clinical trials testing both safety and efficacy in Read More >

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Gates Foundation Issues Biotech Call to Action

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Today, Trevor Mundel from the Bill & Melinda Gates Foundation discussed the untapped potential of biotech companies to help develop new and better drugs, vaccines, diagnostics, and delivery systems for global health solutions at the 2014 BIO International Convention. This is important because 90 percent of the global infectious disease burden is borne by those who live in developing countries, yet the foundation believes that little attention is paid to health solutions to address these Read More >

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