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Tuesday, August 29, 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.

A wild biotech deal appears...

Gilead Sciences, finally tiring of those quarterly questions about its cash pile, is spending a boatload of its largesse on Kite Pharma, sparking a thousand takes and jolting to life what had been a ghastly scene around the biotech watercooler.

So now what? Is $12 billion too much to buy into what Gilead CEO John Milligan himself called a “labor-intensive kind of business?” Can CAR-T ever prove itself beyond the world of rare blood cancers? Will Gilead’s big move thaw biotech’s long M&A winter?

We have no idea, but opinions abound. Here’s STAT’s Adam Feuerstein on the most important takeaways — and unanswered questions — from the big transaction. And here’s Ed Silverman with a roundup of how Wall Street is parsing the deal.

...and yet no one’s happy

Next month is going to be laden with market-moving biotech data, which could buoy the sector to new heights or shove it back into the basement. Yesterday, we asked readers how they think September will shake out, and the results were less than inspiring.

More than half said they’re preparing for a bloodbath, selecting the option that read “That was worse than a Hillary Clinton tweet,” in reference to the time the then-candidate for president scythed biotech stock prices with just 140 characters. Another 33 percent predicted a month full of hits and misses, while only 16 percent believe biotech can effectively run the table.

We shall see.

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FDA taking rogue stem cell clinics to task

An insane and dangerous cancer treatment — made from a mix of stem cells and contraband smallpox vaccine — was recently seized by federal agents from a California stem cell clinic, StemImmune. It was apparently dosing patients with the unproven injection — risking side effects like inflammation and swelling of the heart. Meanwhile, the FDA sent a warning letter to a Florida stem cell clinic which offered a therapy that caused three women to go legally blind

The actions coincide with a strong new statement from FDA Commissioner Scott Gottlieb on the agency’s plans to crack down on these ne’er-do-well stem cell clinics. He says these “unscrupulous actors” who “exploit the sincere reports of the significant clinical potential” of regenerative medicine put the entire field at risk.

UC Davis biologist and blogger Paul Knoepfler posed some interesting questions about the FDA's planned enforcement action on his site, The Niche. One paramount question: There are 600 dubious stem cell clinics in the U.S. How will the feds tackle them all?

Pharma's favorite TV shows

When flipping channels, you may notice that some shows seem to feature a preponderance of drug ads (cough, Hannity, cough), while others — like, say, Keeping Up with the Kardashians, generally do not?

That’s very much on purpose, as STAT’s Rebecca Robbins reports. Police procedurals, reruns of classics like Family Feud, and political commentators of all stripes draw an aging audience of folks who tend to frequent the pharmaceutical aisle. The Bachelor? Not so much.

Read more on STAT Plus.

More reads

  • Meet the investor shorting Sage Therapeutics going into pivotal epilepsy study results. (STAT Plus)
  • Merck's CETP cholesterol drug cuts heart attacks by a modest 9 percent. (Reuters)
  • ATyr Pharma and when criticizing short sellers goes wrong. (Wall Street Journal)
  • AstraZeneca buys into artificial intelligence for drug discovery. (Reuters)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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