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As the saga of how to pay for Aduhelm unfolds, the biopharmaceutical companies are now taking a close look at how Biogen was able to maintain such a special relationship with FDA officials before the drug’s fast-track approval, and whether or not they might. take advantage of these takeaways in their own dealings with the agency.
What makes Biogen unique, however, is the depth of its relationship with the FDA and the way FDA head of neuroscience Billy Dunn worked alongside the company for years before the quick deal. from Aduhelm. For example, in 2017, Dunn co-chaired a data sharing initiative at the nonprofit C-Path institute alongside Biogen Senior Vice President Samantha Budd Haeberlein, as first reported by the New York Times. In 2018, Dunn and Budd Haeberlein also jointly presented on strengthening communication within the Alzheimer’s drug development community.
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