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Facilitating Payment Reform Pathways for Antimicrobial Drugs through FDA and CMS Collaboration As you know, the rise in antimicrobial resistant infections is a major public health threat. Few treatment options are available and the pipeline of drug candidates is extremely limited. To help address this issue, Duke-Margolis has been focused on policy initiatives that could […] |
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The Food and Drug Administration is holding a public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections." The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy. Presentations by Kevin Outterson, […] |
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Today, many innovators in the diagnostics industry struggle for funding, and yet news of large scale acquisitions or large (over $30M) funding rounds pops up regularly. How can innovators better understand the changing dynamics of the funding environment to succeed? How can investors know if they are getting exposed to the potentially best investments? Whether […] |
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