• The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug.
  • Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.
  • Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.
  • Biogen’s reputation may be damaged beyond repair.

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post, says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science?

SUMMARY: Endpoints and STAT news are reporting that Biogen is coming under intense scrutiny when it comes to their failed drug aducanumab. According to the Endpoints report “On Monday Baird’s Brian Skorney — a prominent Wall Street analyst — kicked off the week with a scathing assessment of the data Biogen has presented to date and a declaration that barring a deus ex machina — an unlikely savior —  there’s no way the FDA would approve a drug on this data, outlining a variety of issues that would freeze any other drug in its track”.

KEY TAKEAWAY: “We still believe that amyloid beta hypothesis is potentially the right approach for the treatment of Alzheimer’s disease,” an Eisai spokesman told Reuters. What made Wall Street and everyone else, Eli Lilly, AstraZeneca, Merck, and Roche — have reported out decisive late-stage failures over the last year that all point to one conclusion: Targeting amyloid-beta alone in symptomatic patients may hit your biomarkers on effect, but it doesn’t delay the ruthless march of the disease.