The Readout Damian Garde & Meghana Keshavan

Apparently the FDA likes Biogen’s Alzheimer’s drug after all

Months of expert research, quantitative analysis, and tireless polling proved wrong this week, as the FDA staff tasked with reviewing drugs looked favorably upon Biogen’s controversial treatment for Alzheimer’s disease.

In breathlessly awaited documents released yesterday, FDA reviewers endorsed Biogen’s case for aducanumab, a treatment with a checkered past in clinical development. FDA staff, who tend to lean negative in drug reviews, were effusive about aducanumab’s efficacy in its lone positive Phase 3 trial and more than willing to see the silver linings to the drug’s decidedly negative study.

This came as a shock on Wall Street, where even the most bullish analysts looked at aducanumab’s future at the FDA as a virtual coin flip. To Baird analyst Brian Skorney, who has been especially skeptical of Biogen’s odds, the staff review made one thing clear: “The FDA wants to approve this drug.”

Read more.

Now what?

Yesterday’s surprise words from the FDA sent Biogen’s stock price up about 40%, adding roughly $15 billion to the company’s market value. But it’s worth remembering that this was always just a prologue to Friday, when a panel of independent FDA advisers will review the aducanumab evidence and vote on whether to recommend approval.

We’ll be covering Friday’s all-day meeting right here, if that’s something you’d like to bookmark. But in the meantime, we want to know what you think. Will the panel — whose membership you can find here — be as sanguine as the FDA staff? Or will they channel the many neurologists who’ve said the only way to be certain about aducanumab’s effects is for Biogen to run another clinical trial?

When the panel votes at the end of the day, members will be _______.

strongly in favor of aducanumab
strongly against it
pretty much split

Federal dysfunction is good for stocks

Biotech’s most closely watched index hit an all-time high yesterday amid demands of electoral recounts, threats of legal action, and more than a few warnings of a constitutional crisis to come.

It would appear, in the eyes of investors, that governmental disarray is a net positive for the drug industry. As SVB Leerink analyst Geoffrey Porges wrote in a note to clients, the big risk for pharma was the prospect of a Democratic-controlled Senate, which now appears impossible. With that off the table, the odds of the U.S. government mounting a coordinated effort to constrain drug prices or otherwise imperil pharmaceutical profits are exceedingly long, no matter who becomes president or how long it takes to count ballots.

And it goes beyond the drug industry. The S&P 500 had its best day since June, driven largely by the market perception that a gridlocked government guarantees against sweeping policy changes, whether in the form of regulating major tech companies, raising taxes on corporate giants, or capping the cost of medicine.

Alphabet’s big bet on depression comes up short

A division of Alphabet working to identify a single biomarker for depression and anxiety failed to reach its ambitious goal despite employing a bevy of technological buzzwords in the process.

As STAT’s Casey Ross reports, the idea was to use machine learning to comb brainwave data and home in on an indicator that could make measuring mental health as simple as reading a glucose monitor. X, as the Alphabet subsidiary is called, admitted defeat this week, acknowledging that it was never able to establish that its technology could make a difference for patients.

Now that the project has run its course, X has made its hardware designs and source code freely available to anyone interested, leaving open the possibility that another group of researchers might figure out how to push the technology forward.

Read more.

More reads

  • ‘Science was on the ballot’: How can public health recover from a rebuke at the polls? (STAT)
  • China's Fosun to seek approval for BioNTech's COVID-19 second vaccine, ends trials on first. (Reuters)
  • Americans are spending more on specialty medicines, despite rebates given to payers. (STAT+)

Thanks for reading! Until tomorrow,

Thursday, November 5, 2020


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