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Friday, February 16, 2018

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews. We're taking Monday off to observe Presidents Day, so we'll see you Tuesday.

A trip to 'the poopy lab' in the interest of drug development

As biotech researchers around the world endeavor to turn gut bacteria into therapeutic gristle, one Canadian scientist has invented a cybernetic helper.

Meet the RoboGut, property of Emma Allen-Vercoe, who uses it to study bacteria isolated from human fecal donations. It is often aromatic work.

“This is what we call the poopy lab,” Allen-Vercoe said of her small-town outpost. “Every donor that we use has a distinct aroma, because they have a different profile
of microbes in the gut, so it's like a fine wine — just not quite so fine." 

As STAT's Eric Boodman reports, the idea is to isolate the good bugs, proliferate them, and then craft drugs that could change the weather in a patient's microbiome, treating infectious disease, inflammatory bowel disorders, or obesity in the process.

Read more.

Look at the new tricks CRISPR has learned

Gene editing is so 2014. The leading lights of CRISPR have dug deeper into the world of molecular scissoring and found yet more uses for everyone's favorite acronym.

As STAT's Sharon Begley reports, there's DETECTR, which could be used to spotlight tiny strains of HPV in test tubes and thus come in handy in viral outbreaks. Then there's CAMERA, which functions like a cellular time machine, blasting away extraneous DNA to leave only the telltale strands of the past. And the aptly named SHERLOCK, which, as you might imagine, is designed to ferret out unwanted molecules.

Read more.

FDA to Alzheimer's companies: We can't wait for you to get better at your jobs

Good news: The FDA is open to approving treatments for Alzheimer's disease based on biomarkers, rather than holding out for clinical outcomes. Bad news: The drug industry doesn't seem to be particularly close to finding a biomarker that can predict actual benefit.

In a new draft set of rules, the agency points out that improving a biomarker — like, say, amyloid deposits in the brain — "may, in principle, serve as the basis for an accelerated approval." But then, in the next paragraph, the FDA correctly points out that "there is unfortunately at present no sufficiently reliable evidence that any observed treatment effect on such biomarker measures would be reasonably likely to predict clinical benefit."

Which is to say: Keep trying. We'll be waiting.

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Well that was boring

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(Jennifer keefe/STAT)

Yesterday marked the official halfway point of 2018’s first quarter, a quarter expected to be positively bursting with catalytic biotech data readouts that would undoubtedly shift the industry narrative for the whole year.

And then nothing really happened. Or well not nothing. Gilead Sciences won a widely expected FDA approval, and Vertex Pharmaceuticals advanced its cystic fibrosis program according to plan.

But Incyte, at work on a cancer drug whose success or failure could see billions of dollars materialize or disappear, was silent. So too were BioHaven Pharma and its pill for acute migraines, Dermira and its acne drug, plus all the peanut allergy companies vying for supremacy.

On the bright side, at least the next 1.5 months will be busy.

Oof

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More reads

  • Smaller biopharma companies face more securities fraud lawsuits than ever before. (STAT Plus)
  • Celgene spinout Celularity raises $250 million to develop placental cells to attack cancer. (Forbes)
  • We're getting a DNA emoji — but it's twisted the wrong way. (Gizmodo)

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Thanks for reading! Until next week,

Damian

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