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Thursday, February 15, 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. Oh and one more thing: STAT has an app! Whether you're on iOS or Android, you can now get the latest health and science news in the palm of your hand.

Say, where's that Northwest Bio data?

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Maybe consider walking. (Dom Smith/STAT)

Most biotechs are eager to find out if their experimental cancer drugs can help patients. Makes sense, right? A positive clinical trial can lead to an approval, which segues nicely to boffo sales and profits. So, hell yes, let’s analyze that study ASAP! 

That’s pretty much how it goes, except for Northwest Biotherapeutics, which as Adam Feuerstein reports, seems to be doing its best not to know the fate of an experimental brain tumor cancer vaccine. A Phase 3 clinical trial was completed one year ago but the data have not been analyzed or disclosed. Trial investigators and outside cancer experts say the long reporting delay is extraordinary and casts doubt on the outcome — whenever Northwest Bio decides to say something.

Read more.

The perils of 'variability' at Biogen

In general terms, “variability on the primary endpoint” is not a phrase you want to hear applied to a clinical trial whose results will completely change the fate of a biotech company. But if you're a Biogen investor, that's exactly what the company told you about aducanumab, the all-important Alzheimer's disease treatment now in Phase 3.

Except Biogen didn't tell you through the traditional means — a press release, an SEC filing — but rather "you" heard if you were in the audience at the Leerink conference in New York or following along on the webcast, which perhaps explains why the company's share price fell as much as 9 percent midday.

Anyway, the news is basically this: Biogen is recruiting more patients to the two Phase 3 aducanumab trials because after taking a look at the data — without unblinding who's getting the drug and who's getting placebo — the scores were more variable than the company had expected.

Is that bad? Biogen says no. But, also, maybe? Read more.

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An FDA nod for a concussion blood test

Watch out, footballers. We might soon see an uptick in confirmed concussion diagnoses: The FDA just approved the first blood test to help doctors determine whether their patients have traumatic brain injury. 

The Blood Trauma Indicator test, marketed by Banyan Biomarkers, measures the levels of two proteins — UCH-L1 and GFAP. If elevated, it’s likely that the person’s suffered a form of brain damage that’s typically picked up only by costly and time-consuming CT scans. 

This isn’t a rapid point-of-care test, mind you — the Banyan diagnostic takes three to four hours. But the idea is for doctors to use this as a first line of testing, so as to prevent undue brain scans — and the resulting radiation exposure (and bills).

Read more.  

CMS is bracing for drug price hikes

The people who foot the bill for Medicare and Medicaid are expecting drug prices to rise 4.4 percent next year, outstripping last year's 2.1 percent increase.

As STAT's Ed Silverman reports, that change is part of why CMS expects to spend 6.6 percent more on all drugs — branded or generic — in 2018 over 2017. But it's not the only reason. The dollar value of brand-name drugs losing patent protection in 2018 will be less than in previous years, CMS says, and last year's aberrant drop in generics prices is unlikely to repeat itself.

Read more.

More reads

  • Bristol, needing a cancer immunotherapy boost, pays shockingly steep price for Nektar drug. (STAT Plus)
  • Astellas pledges $102.5 million for universal donor cell company. (FierceBiotech)
  • Vertex says non-opioid pain drug hits mark in study. (Boston Business Journal)

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Thanks for reading! Until tomorrow,

Damian

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