Sign up for our daily briefing

Make your busy days simpler with the Axios AM and PM newsletters. Catch up on what's new and why it matters in just 5 minutes.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Catch up on the day's biggest business stories

Subscribe to the Axios Closer newsletter for insights into the day’s business news and trends and why they matter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Sign up for Axios Pro Rata

Dive into the world of dealmakers across VC, PE and M&A with Axios Pro Rata. Delivered daily to your inbox by Dan Primack and Kia Kokalitcheva.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Sports news worthy of your time

Binge on the stats and stories that drive the sports world with the Axios Sports newsletter. Sign up for free.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Tech news worthy of your time

Get our smart take on technology from the Valley and D.C. with Axios Login. Sign up for free.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Get the inside stories

Get an insider's guide to the new White House with Axios Sneak Peek. Sign up for free.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Denver news?

Get a daily digest of the most important stories affecting your hometown with Axios Denver

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Des Moines news?

Get a daily digest of the most important stories affecting your hometown with the Axios Des Moines newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Twin Cities news?

Get a daily digest of the most important stories affecting your hometown with Axios Twin Cities

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Tampa Bay news?

Get a daily digest of the most important stories affecting your hometown with the Axios Tampa Bay newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Charlotte news?

Get a daily digest of the most important stories affecting your hometown with Axios Charlotte

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Nashville news?

Get a daily digest of the most important stories affecting your hometown with the Axios Nashville newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Columbus news?

Get a daily digest of the most important stories affecting your hometown with the Axios Columbus newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Dallas news?

Get a daily digest of the most important stories affecting your hometown with the Axios Dallas newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Austin news?

Get a daily digest of the most important stories affecting your hometown with the Axios Austin newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Atlanta news?

Get a daily digest of the most important stories affecting your hometown with the Axios Atlanta newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Philadelphia news?

Get a daily digest of the most important stories affecting your hometown with the Axios Philadelphia newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top Chicago news?

Get a daily digest of the most important stories affecting your hometown with the Axios Chicago newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Sign up for Axios NW Arkansas

Stay up-to-date on the most important and interesting stories affecting NW Arkansas, authored by local reporters

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Want a daily digest of the top DC news?

Get a daily digest of the most important stories affecting your hometown with the Axios DC newsletter.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Biogen has yet to publish aducanumab trial results in a peer-reviewed journal. Photo: Biogen

Biogen recently submitted a paper to JAMA, a top medical research journal, that analyzed results from the clinical trials of its new Alzheimer's drug, Aduhelm. However, Biogen later withdrew the paper because JAMA considered rejecting it unless edits were made, according to two sources familiar with the matter.

Why it matters: The FDA's decision to approve Aduhelm has been mired in controversy; experts say there simply isn't strong enough data to show the drug works. And it appears medical journal reviewers also weren't sold on Biogen's interpretation of the data.

How it works: Drug companies almost always publish clinical trial results in a peer-reviewed journal before obtaining FDA approval, but Biogen still hasn't done so for Aduhelm.

  • Biogen executives said during a conference call last week the company was working to get Aduhelm's phase 3 results published in a peer-reviewed journal.

When Axios asked about Biogen's submission to JAMA, the company declined to answer questions beyond saying, "JAMA did not reject the publication. Biogen withdrew the publication from JAMA and decided to pursue other publication opportunities."

  • "To protect the integrity of the scientific review process, Biogen does not comment on publication deliberations with journals and their editors," the company said in a follow-up statement.
  • A JAMA spokesperson said: "Our policy is that we can neither confirm nor deny that a manuscript is or has been under consideration."

The central issue is the contrasting results of Biogen's two late-stage trials, both of which compared Aduhelm (also known as aducanumab) with a placebo. The company halted the studies in 2019 after early reads showed the drug didn't work.

  • One of the trials failed outright.
  • The second trial was initially deemed a failure, but Biogen conducted an after-the-fact analysis that found a subgroup of patients who had reduced levels of amyloid, which are sticky plaques that build up around the brain's neurons, and did slightly better on cognition tests.
  • The FDA used that outcome of lowered amyloid as a "surrogate" measure and as the basis for the accelerated approval.
  • The FDA's rationale contradicted its own guidance on Alzheimer's drugs. Agency officials also explicitly told outside experts, who almost unanimously thought the drug should not be approved, that they were not considering accelerated approval.
  • Biogen is now selling Aduhelm, which also carries risks of brain swelling and bleeding, and has up to nine years to complete a post-approval trial confirming the drug's effectiveness.

Between the lines: Physicians and researchers often read full clinical trial data in journals as a way to validate drug companies' claims about drugs. They still don't have that option for Aduhelm.

  • "I suspect [Biogen] is reluctant to have the full data undergo the greater scrutiny that the peer review process would provide," Scott Emerson, a University of Washington biostatistician and a member of the FDA committee who voted against Aduhelm, told Zach Brennan of Endpoints News last month.

Go deeper: Biogen's attempt to "to gaslight the entire industry"

Go deeper

Bryan Walsh, author of Future
Oct 20, 2021 - Technology

The AI pharmacist

Illustration: Annelise Capossela/Axios

Artificial intelligence — the ultimate optimization engine — is meeting one of its biggest challenges: untangling the messy, slow and expensive work of drug development.

Why it matters: Even as computing power has gotten faster and cheaper, drugs remain slow and costly to develop, in part because of the sheer work in selecting a candidate and getting it across the finish line.

Biden says he'll make Supreme Court pick by end of February

President Biden speaks on the retirement of Supreme Court Justice Stephen Breyer in the Roosevelt Room of the White House. Photo: Yuri Gripas/Abaca/Bloomberg via Getty Images

President Biden on Thursday said he will announce the nominee for Supreme Court Justice Stephen Breyer's replacement by the end of February.

Driving the news: Biden also affirmed that he will nominate a Black woman to replace Breyer, saying "it's long overdue."

Stephen Breyer formally announces retirement from Supreme Court

Photo: Andrew Harnik/AP

Justice Stephen Breyer on Thursday sent a letter to President Biden formally announcing his retirement from the Supreme Court.

State of play: Breyer said his retirement will take effect when the court "rises for the summer recess (typically late June or early July) assuming that by then my successor has been nominated and confirmed."