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The Readout Damian Garde

Gottlieb picked an FDA successor. Trump might have other ideas

When Dr. Scott Gottlieb stepped down from the job of FDA commissioner earlier this year, he hand-picked Dr. Ned Sharpless to serve the role in interim. Most people who care about this sort of thing assumed Sharpless would get the permanent nod in time, as that tends to be how it goes.

And yet, as STAT’s Nicholas Florko reports, President Trump met Wednesday with a different doctor, Texas oncologist Stephen Hahn, about the FDA job.

That’s despite the fact that five former FDA commissioners have publicly backed Sharpless to become the permanent chief. And all this intrigue has a deadline: Federal law says Sharpless has to step down by Nov. 1 if he hasn’t been formally nominated to serve as permanent commissioner.

Read more.

What separates good drug companies from mediocre ones?

Have biohackers sold out? And who's going to run the FDA?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. First, STAT's Matthew Herper joins us to discuss his recent look at the past 10 years of science at Pfizer and what it says about how the world's biggest makers of medicine are thinking about invention. Then, we talk about the weekend's big biohacker conference, where the fringes of science embraced a bit of the mainstream, and hear an interview with a magician cyborg who has nearly 30 magnets and microchips implanted in her body.

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

Get ready for more KRAS news

Earlier this year, Amgen made headlines after revealing that one of its drugs had showed unprecedented promise against one of cancer’s wiliest targets, albeit in a small study. This weekend, we’ll learn more.

At Europe’s World Conference on Lung Cancer, Amgen will present new data on AMG 510, the treatment that, last we heard, led to a 50% response rate in a particularly hard-to-treat group of patients. 

The thing is, no one’s exactly sure what those new data will entail. Wall Street expects Amgen to have treated more patients for a longer period of time, but the company hasn’t provided specifics. As always, if the earlier response stabilize or even improve, that’s good. If they seem to wane over time, that’s less good. But we won’t know anything until Sunday.

The fascination with AMG 510 goes well beyond Amgen. The drug targets KRAS, a protein implicated in a host of cancers that has largely proved impervious to medicinal chemistry. That means AMG 510’s progress is seen as a barometer for other KRAS medicines, particularly one in development by a small company called Mirati Therapeutics, whose stock price is up more than 25% since Amgen’s first disclosure.

Here comes a test of the IPO window

Biotech’s two-month paucity of IPOs could come to an end this week, with a pair of companies expected to price their shares and give us all a miniature update on investor sentiment.

First is Satsuma Pharmaceuticals, a company with a late-stage migraine treatment and a plan to raise $80 million at a roughly $260 million valuation. Then there’s SpringWorks Therapeutics, a Pfizer-founded drug developer aiming to raise about $130 million at a valuation above $700 million.

They’d mark the 30th and 31st IPOs in a year that has been something of a mixed bag for biotech debutantes. The median 2019 biotech IPO is up more than 10% from its debut, but that figure glosses over the sinking fortunes of some companies that came in with high private valuations. Meanwhile, according to a recent survey from Cowen, investors are losing interest in buying into biotech offerings.

Global Blood just might pull this off

Last year, when Global Blood Therapeutics said it would submit a sickle cell disease drug for FDA approval based on secondary evidence, people were more than a little skeptical. Then, in June, when the company did just that, experts warned there was no way to be sure its drug would actually improve patient outcomes.

Then, yesterday, Global Blood said that not only had the FDA accepted that application, but the agency was “not currently planning” to convene a panel of outside experts to weigh in on the drug.

That would suggest the FDA is comfortable with the idea that increasing hemoglobin, which Global Blood’s drug can do, will translate to a long-term benefit for people with sickle cell, something Global Blood’s clinical trials did not demonstrate.

The company’s share price rose about 15% on the news, as investors inferred that Global Blood’s drug, voxelotor, is now that much likelier to win approval. We'll find out in about six months.

More reads

Thanks for reading! Until next week,


Friday, September 6, 2019


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