Monday, November 21, 2016

The Readout by Damian Garde & Meghana Keshavan

Happy Monday from The Readout, where we keep you on top of all things biotech. Follow us on Twitter: @damiangarde@megkesh, and @statnews.

Money is flowing into biotech again

A whopping $2.7 billion flooded into the biotech sector in just the last week, according to Raymond James Financial, marking the best period the firm has ever recorded. For context, other than a brief summer spell, money has generally been seeping out of the industry this year, as concerns about a drug pricing crackdown and clinical failures led generalist investors to lose faith in the sector.

So, is the election bounce sustainable?

On the one hand, you could say biotech was unduly oversold in the run-up to the election as investors conjured an unlikely doomsday scenario, meaning things are now returning to something more akin to normalcy.

On the other hand, you might believe the industry is in for some fundamental changes in the coming the years and that the latest pop is just a prelude to another drop as reality sets in and a new, less lucrative normalcy takes shape.

You could also say that relying on the Keynesian beauty contest of the stock market to determine the actual value of anything is pretty foolish. But then, of course, you’d need three hands.

FDA backs off new testing regulations

FDA has been warning for some time that unregulated laboratory-developed tests pose a danger; some have not even been scientifically validated. So the agency has been crafting new guidelines for LDTs, a category that includes cancer screenings and DNA analyses marketed directly to consumers.

Don't expect to see the new rules any time soon.

FDA said late Friday that it's backing off efforts to close the LDT loophole until it gets input from the new president and Congress.

Given Donald Trump's promise to reduce regulation, it seems highly unlikely the regs will get off the ground. At least not for the next four years.

Read more.

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Whose moonshot is it anyway?

Dr. Patrick Soon-Shiong, billionaire entrepreneur and successful neologist, has big plans in oncology, neatly packaged under the label “Cancer MoonShot 2020.” Thing is, the people at the MD Anderson Cancer Center in Texas have had a “Moon Shots” program since 2012, which they believe to be the one true lunar metaphor in oncology.

And so, of course, they’re suing.

As first reported by The Cancer Letter, MD Anderson wants Soon-Shiong to stop using the phrase “moonshot,” saying his appropriation of the term is likely to “cause confusion, mistake, and/or deception, all to the irreparable harm” of the cancer center. Furthermore, Soon-Shiong’s infringement is “willful, intentional, and/or conducted in bad faith,” MD Anderson alleges, adding that it would also like to paid damages and attorney fees.

(No word on whether the hospital will go after Joe Biden next.)

A spokesman for Soon-Shiong didn’t respond to a request for comment, and his company, NantHealth, made no mention of the litigation in its latest filings with the SEC.

Meanwhile, the man once called “the world's richest doctor” spent part of the weekend in the company of someone well versed at settling lawsuits: President-elect Donald Trump. The two dined together and discussed innovation and “national medical priorities that need to be addressed in our country,” as the transition team put it.

Soon-Shiong's takeaway


Theranos booster for Defense Secretary?

Just in case worlds haven't been colliding enough lately, we take this moment to note that Trump is considering nominating General James "Mad Dog" Mattis as Secretary of Defense.

Mattis is a retired Marine commander — and happens to sit on the board of directors at Theranos.

Before joining the board, Mattis pushed hard to test Theranos' blood-testing technology in war zones, the Washington Post reported last year. When the Pentagon raised concerns about the company's intent to distribute the tests without FDA clearance, Theranos CEO Elizabeth Holmes asked Mattis to intervene. The general forwarded her email to other military officials, asking them why the Theranos blood test had not yet been deployed in a battlefield.

Mattis told the Post last year, several months after the first damning stories about Theranos appeared, that he had “the greatest respect for the company’s mission and integrity.”

Biophilosophy with Barack Obama

President Obama is ever the bio-nerd, even when he's feeling down. We caught him waxing biologic in a recent New Yorker article, where he shared how he'd explained the election outcome to his daughters:

“What I say to them is that people are complicated," he said. "Societies and cultures are really complicated. . . . This is not mathematics; this is biology and chemistry. These are living organisms, and it’s messy."

More reads

  • Novartis and Verily are delaying plans to test a high-tech contact lens. (STAT)
  • Famed litigator David Boies has cut ties with Theranos. (Wall Street Journal)
  • Scientists hope Trump won't decrease the flow of federal research dollars.(Boston Globe)
  • Sounding the alarm: UK biotech struggles to cope with Brexit. (Forbes)

Have a news tip or comment you want to send us?

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Thanks for reading! Until tomorrow,

Damian & Meghana

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