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Wednesday, May 31, 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.

Printer cartridges deal pharma a heavy blow

Who needs Congressional bluster and public outcry? All it takes is a tiff over office supplies to shake up drug pricing.

No, really. A new Supreme Court ruling on international printer cartridge sales could have major implications for drug pricing and global health. 

Here's why: Pharma prices its drugs differently around the world — but patent law prevents third party sellers from importing cheaper medications from, say, India back into the US. That could change with this new ruling.

Read more on STAT Plus.

We hired Adam Feuerstein

Beer aficionado, Twitter celebrity, and intrepid biotech columnist Adam Feuerstein will soon be found here in the pages of STAT, where he’ll bring all the insight, wit, and aversion to piffle on which he made his name.

For those unfamiliar, Adam is a dogged and occasionally profane chronicler of biotechs large and small, relied upon by thousands of readers to dig through the industry's daily morass of data and spin for actual news.

For all of you who know him well, Adam had this to say about his move to STAT: “I'm still the same [you can use your imagination as to the expletive he chose] that I've always been. Just in a different place."

That place will be STAT come June 19.

Amgen likes to sue

Amgen’s got more lawyers than it’s got scientists, the joke goes. And the company didn't help its rep on that score with this move: It’s suing the FDA.

The company filed a complaint against US regulators for not giving it six months of pediatric exclusivity for its hyperparathyroidism drug Sensipar. In essence, Congress requires FDA to grant those extra six months to drugs for which pediatric studies were conducted.

Amgen’s argument: “The studies need not demonstrate that the drugs are (or are not) actually safe and effective in children to warrant pediatric exclusivity,” according to Life Sciences IP Review.

This is unconventional, but not unheard of. Last year, for instance, Eagle Pharmaceuticals sued FDA for refusing to grant seven years of marketing exclusivity for its own rare disease drug, Bendeka. And AstraZeneca has sued FDA to prevent generic competition for its cholesterol drug Crestor. 

Still, Amgen’s litigious ways are making the company quite a name. And not with patients.

No, Theranos didn’t just raise $582 million

Twitter was briefly aghast yesterday as Theranos’ latest filing with the SEC made the rounds. Had the dehorned unicorn really convinced someone — 34 someones, that is — to invest $582 million?

No, as fans of fine print will have noted. That filing detailed not a new fundraise but rather Theranos’ deal with a group of shareholders in which the company handed over more equity in exchange for a promise that they won’t sue. And that $582 million figure is the value of those shares at their initial issue price, which, considering Theranos’ recent woes, has probably come down just a bit.

So, no, biotech’s biggest cautionary tale is not suddenly in the money once more. That said, the fact that jilted Theranos investors apparently want more shares of the company is still arguably pretty baffling.

More reads

  • Paul Ryan appoints Soon-Shiong to HHS committee. (Politico)
  • From importation to PBM reform, here's a look at some drug pricing proposals under consideration. (New York Times)
  • On ASCO's eve, experts fret over backlash to cancer combination therapies. (Xconomy)
  • All the doom and gloom surrounding Alexion has left the company undervalued, according to one investor. (TheStreet)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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