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The Readout Damian Garde

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Make what you will of these Biogen data

Biogen, with the ear of an entire industry, finally presented the details behind its plot to turn a once-abandoned molecule into an approved treatment for Alzheimer’s disease. But the data aren’t likely to change an already polarized conversation.

As STAT’s Rebecca Robbins and Matthew Herper report, Biogen’s longform case for the drug, called aducanumab, relies on buying into the company’s explanation of how two identically designed trials came up with opposing results. The company reeled through dozens of complicated slides to explain its position, which hinges on the belief that patients who got the highest dose for the longest amount of time experienced a real benefit.

But the reaction has largely split along party lines. Experts and analysts who were swayed by Biogen’s earlier aducanumab claims saw the data as a validation of the drug’s promise, while those on the skeptical side called the presentation problematic.

Read more.

What if clinical trial participants unionized?

And how do you know if a “positive” study is positive?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. First, we dig into Biogen’s aforementioned data in Alzheimer’s disease, with on-the-ground takes from experts at a scientific conference. Then, STAT’s Eric Boodman joins us to spin a drug-discovery yarn involving one-eyed sheep, Basque farmers, and the quest to treat a rare form of cancer.

You can listen to the episode here. To listen to future episodes, be sure to sign up on Apple Podcasts, Stitcher, Spotify, or wherever you get your podcasts.

Veritas hits a false note

Veritas Genetics, a company that offered whole genome sequencing to consumers, ran into an “unexpected adverse financial situation,” and now it’s suspending its business in the U.S.

As STAT’s Kate Sheridan reports, the news arrived in the form of a tweet, imperiling the future of a startup that once hoped to offer a $99 genome. Veritas’s pitch was that its test delivered orders of magnitude more data than popular offerings from 23andMe and Ancestry, saying its approach was different the way “a sports car is different from a tricycle.”

Veritas’s financial trouble, whatever the details may be, underlines some emerging concerns about just how viable consumer genetic testing is as a business. Illumina, the leading provider of genomic analysis technology, sent waves through the industry over the summer when it slashed sales forecasts and blamed a decline in demand for consumer-facing products.

Read more.

An FDA rejection leaves families reeling

Katie Luckesen thought her life was going to change Wednesday. A treatment for the rare and deadly pediatric athymia was expected to win FDA approval, news that would mean her 2-year-old son, Charlie, could receive a potentially life-saving therapy.

As STAT’s Eric Boodman reports, that’s not what happened. Enzyvant, the company developing the treatment, said yesterday that the FDA had rejected its application over concerns about manufacturing. The future of the treatment is now uncertain.

Enzyvant’s would-be product is a tissue-based therapy for pediatric athymia, a condition in which children are born without a thymus and thus unable to produce infection-fighting T cells. The process involves removing a segment of thymus from a baby, washing out the immune cells, and then implanting the tissue into a kid with congenital athymia.

Read more.

More reads

  • Acquisitions, not Congress, will chart biotech’s course in 2020, experts predict. (STAT Plus)
  • Scientists dodge FDA to offer a $1 million anti-aging treatment in Colombia. (OneZero)
  • More than 100 small biotech CEOs sound off against Pelosi’s signature drug pricing bill. (STAT Plus)

Thanks for reading! Until next week,

Friday, December 6, 2019

STAT

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