Wednesday, September 13, 2017

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.

Sage gives reason to doubt its wisdom


(Jennifer Keefe/STAT)

We’re updating our September scorecard to account for the latest domino to fall in biotech’s breathless late summer: Sage Therapeutics’ treatment for a rare seizure disorder failed in a clinical trial.

And how. The treatment effect was barely distinguishable from placebo, and Sage is moving on from seizures for now. But that trial was only a prelude to its bigger, higher-stakes bet on post-partum depression. Data in that disease are expected by year’s end, and Sage’s share value, which dipped just 15 percent yesterday, will swing majorly on those results. Adam Feuerstein runs you through 5 key things to know about the coming readout.

Read more on STAT Plus.

Gottlieb's baby steps to orphan drug reform

FDA chief Scott Gottlieb has lectured far and wide about his displeasure with all those drug makers “gaming the system.” Now, he’s making moves to close one regulatory loophole concerning the Orphan Drug Act — because, as he writes in a blog post, some drug makers are using orphan status to “sidestep other important public health goals set out by Congress.” 

This is all part of Gottlieb’s promise to eliminate the current backlog of orphan drug designation requests that are pending FDA review. 

But the loophole Gottlieb’s after would result in more of a baby step than sweeping change. 

Read more on STAT Plus. 

Sponsor content by Chilmark Research

Healthcare providers, payers aligning to coordinate care: Technology gaps present growth opportunities

Today’s environment of government initiatives, outcomes-based payment models, and provider consolidation have created deep and complicated challenges with explosive opportunities for innovation, collaboration, and leadership. Convergence 2017, taking place in Boston this fall, will bring together senior executives from across the healthcare sector to discuss and learn about the challenges and opportunities for all stakeholders in this evolving landscape.

To learn more about this first-of-its-kind event, click here.

The thing about developing a Zika vaccine …

… is that it’s really hard, and even if you succeed, it’s probably not all that lucrative.

Sanofi’s decision to pull the plug on its effort is the latest setback to the global cause, a decision driven by economics as much as science. Meanwhile, researchers, drug developers, and public health officials are quickly learning that their earlier optimism may have been misguided, STAT’s Helen Branswell reports.

“Two years ago ... people thought it would be easy and straightforward to make a Zika vaccine based on all the years of knowledge we had in making other vaccines for other flaviviruses such as dengue, etc.,” BARDA Director Rick Bright told STAT. “We did learn a lot from those other experiences, but no vaccine is easy to make.”

Read more.

That's a whole lot of happy people biking

Americans are screen junkies, this we know. But Sen. Claire McCaskill wagers that we spend an astounding 16 hours a year absorbing pharmaceutical ads. We did the math — and the results surprised us. Per STAT calculations, that figure’s closer to 18.6 hours a year.

Anyone else want that slice of life back?

Read more on STAT Plus.

Hell hath frozen... Shkreli offers apology?

Not for all the price-hiking, and Ponzi-ing, and smirking, mind you, but for harassing Hillary Clinton. Martin Shkreli offered a $5,000 bounty on Facebook to anyone who would yank out a strand of Clinton’s hair during her book tour so he might sequence it. The Secret Service did not take kindly to the posting, nor did prosecutors — who want him jailed

Now, Shkreli has penned a letter to “personally apologize” to U.S. District Judge Kiyo A. Matsumoto, who presided over his trial this past summer. 

“I want to assure Your Honor that I am not a violent person, have never personally engaged in any violent behavior, nor have I ever intentionally encouraged anyone to do so,” he writes. 

Read the full letter, which was posted on Twitter by CNBC’s Dan Mangan. 

More reads

  • California moves closer to adopting drug transparency law. (STAT Plus)
  • It's official: Health, and not just wellness, is Apple's future. (CNBC)
  • Mulling over that Mitalipov human embryo CRISPR paper, many questions remain. (Knoepfler Blog)
  • Alexion cutting 600 jobs and moving headquarters in major shakeup. (STAT)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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