Biogen announced that CEO Michel Vounatsos is being replaced as the big biotech undergoes a restructuring of the pipeline. It’s long overdue but kind of like putting smoke detectors in a house that has burnt down.
Board members and senior executives are bailing out of Biogen but will there be enough life vests? What has/is happening at Biogen is a train wreck, and the only way to correct this disaster is to tear it down and rebuild the company from the top down.
MY POINT: Success is always temporary. When all is said and one, the only thing you’ll have left is your character. Right now, I could make a great argument that Biogen’s character is trashed and that they are a company in dire need of authentic leadership.
- 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”.
WHAT ARE PEOPLE SAYING: STAT news article “I used to work on Biogen’s Alzheimer’s drug. Is the company spinning bad data?” is generating quite a debate. Some people support Biogen’s submission of the drug, while others are skeptical. This could be settled very quickly if Biogen would allow people outside the company to review ALL the data.
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.