Top
image credit: Freepik

FDA “collaborated” with Biogen on Aduhelm approval, says inquiry

December 30, 2022

Category:

The document produced by Oversight and Reform Committee chair Carolyn Maloney (D-NY) and Energy and Commerce Committee chair Frank Pallone Jr (D-NJ) also points to “collaboration” between Biogen and the FDA ahead of an advisory committee meeting that nevertheless resulted in no panellists voting in favour of approval for Aduhelm (aducanumab).

After the regulator ignored its advisors and granted accelerated approval to Aduhelm – the first amyloid-targeting therapy to reach the market – a number of committee members resigned in protest, prompting the lawmakers’ investigation.

Read More on Pharmaphorum