Thursday, November 16, 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.

The FDA is fast, but that's not news


Everyone talks about the accelerating speed of FDA approvals bringing new therapies to the market at a record pace.

But a deep look at the data suggests the agency has been pretty much consistent for more than five years, spanning the tenures of three commissioners.

We used data from Evaluate Pharma to look at the difference between when the FDA promises to approve a drug and the date the agency actually signs off. There have been wild fluctuations, as treatments for cancer and rare disease overwhelming get their green lights early.

But when you subtract the outliers and look at the median, the FDA has been the picture of normalcy.

Read more in STAT Plus.

Meet President Trump's 'murder'ers row

For a guy with an oft-stated revulsion for all things pharma, President Trump sure has surrounded himself with pharma-friendly people.

As STAT's Erin Mershon reports, Trump's willingness to appoint drug industry veterans to government positions stands in stark contrast to previous administrations. The president's payroll includes Dr. Scott Gottlieb, the former industry investor and adviser who runs the FDA, and ex-pharma lobbyists in HHS and OMB.

And this week, of course, Trump nominated Alex Azar, who spent more than a decade at Eli Lilly, to run HHS.

"You have an industry that Trump ran against pretty aggressively, with pretty strident language in 2016, and he is now seeing those industries as essentially farm clubs," said Jeff Hauser, who runs the Revolving Door Project at the Center for Economic and Policy Research.

Read more.

New advances in pancreatic cancer

It’s World Pancreatic Cancer Day, aimed at raising awareness for what remains a notoriously difficult cancer to detect and treat. There have, however, been some intriguing advances in the field. 

Scientists, for instance, are examining the link between diabetes and pancreatic cancer. They're unraveling the genetics of survival and recurrence. And they may finally have found a combination immunotherapy that might help some patients. 

Can these early insights ultimately help develop better diagnostics and treatments for this devastating cancer?

Read more.

And for a beautiful tribute Tom Marsilje, a cancer patient who made it his mission to help others through the clinical trial maze, read this.

Sangamo's fancy fingerwork

Sangamo Therapeutics made a bit of a splash yesterday when it announced that it would be testing its zinc finger gene editing technology in a live patient. The company’s gene therapy, once injected, will cut a Hunter Syndrome patient’s genome in a specific location, and then insert a gene meant to correct an enzyme deficiency. 

So we’re wondering: How big of a splash does this news warrant? 

Here’s the thing. There have been plenty of forays into gene therapy already, especially in mucopolysaccharide disorders like Hunter Syndrome. The big distinction here is that Sangamo is cutting a specific portion of the genome to insert the new gene — whereas in your more run-of-the-mill gene therapies, the viral vectors take root at more random locations in the genome. But in terms of outcome, that really may not matter much. 

So we’re wondering: What do you make of Sangamo’s news?  Click to vote.

Amazing. We’re seeing human in vivo gene editing in action for the first time. Science!

Meh. The distinction between gene editing on the inside of the body versus the outside isn’t all that important.

Publicity stunt. Zinc fingers are like soooo five minutes ago.

More reads

  • Moderna Therapeutics, a $5 billion startup, made its first cancer vaccine — for just one person. (Bloomberg)
  • Long-awaited study finds monthly Vivitrol as effective as daily pill for opioid addiction. (STAT)
  • Acorda takes another hit, reports patient deaths in Parkinson’s study. (Xconomy)

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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