The Readout Damian Garde

There will be no seasteaders at the FDA

At least for now. FDA Commissioner Scott Gottlieb will be replaced, on an acting basis, by the current head of the National Cancer Institute, Dr. Ned Sharpless.

That paves the way for a peaceful transition of power at the FDA, and a future in which some of the strident libertarians once considered for the top job — including one who advocated for lawless ocean colonization — will find no quarter in the agency.

Biopharma stocks ticked upward on the news yesterday as it suggests that the Gottlieb-era FDA, resoundingly liked by the drug industry, is unlikely to change course in the short term. But Sharpless is, after all, only the acting director. Whether he ends up getting nominated for a permanent gig is up to a Trump White House that has been known, from time to time, to buck the conventional wisdom.

Read more.

‘It was jaw-dropping to see the delusional behavior inside the company’

That’s filmmaker Alex Gibney on the process of making “The Inventor,” HBO’s new documentary on Elizabeth Holmes, Theranos, and the danger of ambition unchecked by reality.

STAT’s Rebecca Robbins spoke with Gibney this week at the movie’s San Francisco premiere. Gibney has made a career out of illuminating the gaps between perception and reality, with movies about Enron, Scientology, and Lance Armstrong. Holmes and Theranos fit the bill to an extent, he said, but a closer analog is a figure from history more associated with fearlessness than fraud: Thomas Edison.

Edison and Holmes “both invented personas for themselves to inhabit,” Gibney said. “And they sold their companies in a way by creating larger-than-life celebrity figures that they wrote, produced, and directed.”

The difference is that Edison’s fake-it-til-you-make-it gambit ended with the lightbulb. Holmes’s resulted in an indictment.

Read the interview.

The state of Bristol-Myers-Celgene

We’re less than a month away from Bristol-Myers Squibb shareholders deciding whether buying Celgene for $74 billion is a good idea, so we asked readers: Will management win out, or will insurrectionary investors force a renegotiation?

About 59 percent said the deal is as good as done, betting that the likes of Wellington and Starboard Value won’t be able to rattle enough cages to force the parties back to the table. The remaining 41 percent said the saga is far from over, which leaves open the possibility of last-minute changes to the terms or an outright breakup.

Meanwhile, Baird analyst Brian Skorney has some words of warning for agitated Bristol-Myers shareholders: Be careful what you wish for. The idea that Bristol-Myers is better off alone rests on the possibility that some deep-pocketed party might come along and buy it. But CEO Giovanni Caforio said the company hasn’t talked to a potential suitor since 2017, and even those conversations didn’t yield any offers.

Merging with Celgene may not be ideal, according to Skorney, but the uncertainties of single life could prove much worse for Bristol-Myers. “It's kind of like a two-party system,” he wrote. “You may not like either option, but do you pick the big black void just because the option on the table isn't what you would do if you were running things?

The record for biggest biotech IPO may not last a year

BioNTech, a German company working in mRNA, has gone and hired some bankers to prepare an IPO worth up to $800 million, according to Reuters.

That’s $200 million more than fellow mRNA-tinkerers Moderna Therapeutics raised just three months ago in what was, at the time, the biggest biotech IPO in human history. BioNTech’s offering could price as early as the fourth quarter of this year, Reuters reported.

The news underlines a dramatic reversal of fortune for biotech, which bottomed out last fall before hitting a nadir in December, just in time for Moderna’s debut. That company — like the broader industry — has since rebounded, and 2019’s crop of biotech IPOs are up about 3 percent at the median.

However, where BioNTech is concerned, it’s worth noting that a lot can change in six months’ time. Last summer, as Moderna worked through the arduous process of preparing an IPO, the Nasdaq biotech index was flirting with an all-time high. 

More reads

  • UnitedHealth will require drug rebates to be paid to consumers. (STAT Plus)
  • Lawsuit says Johnson & Johnson was opioid 'kingpin.' (Axios)
  • With a closer look at immune systems, scientists hope to steer infants back onto a healthy track. (STAT)
  • Biotech execs predict big M&A deals ahead. (Endpoints)

Thanks for reading! Until tomorrow,


Wednesday, March 13, 2019


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