Tag Archives: health

BIO Principles on Expanded Access to Investigational, Unapproved Medicines

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Seriously ill patients with limited or no alternative therapies, and who are ineligible or unable to participate in the clinical trials, may desire access to investigational, unapproved medicines.  Such access outside of the clinical trial setting, or “expanded access,” may be sought through a company’s expanded access program, or through individual patient expanded access, if available. We believe that the best way to make innovative biotechnology medicines available to patients is through the efficient development of approved, safe Read More >

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Dr. Petra Kaufmann Video Interview: Clinical and Translational Science Awards Program

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Petra Kaufmann, MD, MSc, Director of the Division of Clinical Innovation at the National Institutes of Health, recently joined us in the BIO Buzz Center to discuss streamlining clinical trials through the Clinical and Translational Science Awards (CTSA) Program. As part of NIH’s National Center for Advancing Translational Sciences (NCATS), the CTSA program is designed to address the development and implementation of national standards and best practices for the full range of translation, from basic Read More >

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Coalition Offers a Remedy for Stagnated Clinical Trials

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Promising new clinical trial data offers fresh hope for the families of Alzheimer’s patients.  A new medication seems to be slowing the disease’s progress, limiting the cognitive decline that characterizes this “long goodbye.” Wouldn’t it be wonderful for patients suffering other diseases to have equally encouraging prospects? But many do not. Part of the problem lies with clinical trials.  For a new medication to receive FDA approval, it must undergo comprehensive testing on actual patients.  Read More >

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What to Watch: Emperor of All Maladies; Killing Cancer

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Cancer is a disease which affects almost 1.7 million people each year in America, and is the fastest growing disease on Earth. Two television shows this week explore the history of the complex illness, as well as recent treatment advances that are providing new hope for many patients. The first is a television adaptation of Siddhartha Mukherjee’s The Emperor of All Maladies: A Biography of Cancer, which won the Pulitzer Prize for Nonfiction. The TV Read More >

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Webinar Today: Comparative Effectiveness Research

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As we continue to see new strides in biopharmaceutical innovation, there is increasing value in having more information on how specific treatments affect patients.  This is the intention behind comparative effectiveness research, which can play a critical role in health care decision-making. Later today, experts will be examining the relationship between comparative effectiveness research and the way health care decisions may be made in the future.  The National Pharmaceutical Council (NPC) will be hosting a Read More >

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