STAT+: Pharmalittle: How Biogen and FDA formed a back channel to push an Alzheimer’s drug; Sanofi to dive into mRNA vaccine development
Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation. But this is to be expected at this time of year, yes? Our formula for keeping cool is to turn up the cooling machine. In any event, there is work to be done, so as always, we have assembled a few items of interest for you. Hope you have a smashing day and, as always, please keep us in mind if you hear anything juicy. …
It was previously known Biogen (BIIB) and the Food and Drug Administration worked together on the Aduhelm drug for Alzheimer’s, but the back-channel relationship between the two started earlier and was far more extensive than disclosed, STAT reports. In spring 2019, when prospects for Aduhelm appeared dead, the company mounted a secret campaign, code-named “Project Onyx,” to resurrect the drug and convince the FDA to give it a green light. Central to the mission was an inside ally: Billy Dunn, the top regulator of Alzheimer’s drugs at the FDA.
