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The Readout Damian Garde

If you're looking for a deep dive into just what each Democratic candidate for president wants to do about drug pricing, we've got a 100-page examination to offer you. You'll find exhaustive details on how each contender's plan would affect biopharma, plus expert commentary on the likelihood of each proposal coming to pass. See pricing and details here.

Are we sure about Celgene’s future in CAR-T?

Celgene, thanks to its $9 billion acquisition of Juno Therapeutics, is angling to be the third company with a CAR-T treatment for lymphoma. But data released ahead of the American Society of Hematology meeting called that future into question.

As STAT’s Adam Feuerstein reports, Celgene’s CAR-T looks relatively comparable to the ones already marketed by Novartis and Gilead Sciences, and it might be less toxic. But the prospect of a third treatment with the same mechanism might not generate a lot of excitement for oncologists. And, considering the disappointing commercial returns of the original two CAR-Ts, success for Celgene could similarly unmoving for investors.

But even that presumes that the FDA will go for Celgene’s pitch. The agency was quick to approve Novartis’s CAR-T back in 2017, but that was when there were no treatments for lymphoma patients with particularly aggressive cancer. Now, with two therapies on the market, might the FDA hold off until Celgene has more data?

Read more.

Something happened to the next big NASH IPO

A company called 89bio, at work on a treatment for the lucratively prevalent liver disease NASH, was expected to raise $70 million in an IPO yesterday. And then it didn’t, and now it’s unclear what happened.

According to IPO Boutique, a research outfit, the problem stems from an “issue” with the SEC and 89bio’s auditors. A spokesperson for the company didn’t respond to emailed questions yesterday.

Whatever that issue is, 89bio needs to resolve it. As the company noted in its IPO paperwork, “there is substantial doubt as to our ability to continue as a going concern." As of June 30, the company had about $22 million in cash, which, at its current burn rate, would be enough to keep the doors open until the end of the year.

Takeda’s success with a dengue vaccine comes with caveats

Sanofi’s decades-long efforts to develop a vaccine for dengue resulted in a global scandal. Takeda is looking to succeed where its rival stumbled, but the company’s success story is nuanced.

As STAT’s Ed Silverman reports, preliminary data on Takeda’s vaccine suggest it’s effective, but experts are holding out for longer-term results before drawing any conclusions. For one, safety issues could emerge over time. But then there’s the legacy of Sanofi’s vaccine, which turned out to pose serious risks to patients who hadn’t already been exposed to dengue. That doesn’t appear to be a problem for Takeda, but only time will tell.

“Let’s make sure nobody runs around claiming an early Pyrrhic victory,” said Scott Halstead, a retired dengue expert.

Read more.

The Senate isn’t wasting any time with Trump’s FDA pick

Two months ago, we learned that President Trump was probably going to nominate Dr. Stephen Hahn to run the FDA. Last week, Trump actually did so. The Senate, by contrast, is moving quite a bit faster.

Yesterday, Sen. Lamar Alexander endorsed Hahn after “an excellent meeting,” and he scheduled a confirmation hearing before the Senate health committee for Nov. 20. If the MD Anderson oncologist gets through that, the full Senate could vote on his nomination as early as December, which could put Hahn in office before the year’s out.

Or not. Back in 2017, Dr. Scott Gottlieb made his way through the confirmation process in less than two months, but that was before the national vaping crisis and widespread concern about dubiously marketed CBD products. Hahn’s trip toward confirmation could be rockier.

More reads

  • The Alzheimer’s Drug Discovery Foundation still expects new treatment options approved by 2025. (STAT Plus)
  • One-shot drug to end Sicilian curse comes at $1.8 million cost. (Bloomberg)
  • First use of CRISPR against cancer in patients clears early safety hurdles. (Associated Press)
  • Woodford’s woes cast a pall over British early biotech industry. (Bloomberg)

Thanks for reading! Until tomorrow,

Thursday, November 7, 2019


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