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The Readout Damian Garde

Biopharma’s greatest hits of the 2010s

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(HYACINTH EMPINADO/STAT)

Depending on the year, we read that the FDA is approving too many drugs or too few drugs, doing it too quickly or too slowly. Less often discussed, however, is how many of them are any good.

With that in mind, STAT’s Adam Feuerstein and Matthew Herper pored over all of the therapies approved in the past decade with one question in mind: Which of these treatments truly mattered? And they came up with 10 drugs that changed the industry, pushed medicine forward, and, in one case, actually cured a disease.

You can find their list here, and you can air your grievances with it by replying to this email or by hounding the authors on Twitter.

Now on to 2020

Last year’s news-packed fourth quarter gives way to a busy calendar in the opening days of 2020, so, to keep you from starting 2020 playing catch-up, here’s a guide to some of the major events expected in the early days of the New Year.

  • We’re going to find out whether Apellis Pharmaceuticals has a future treating the rare disease paroxysmal nocturnal hemoglobinuria. Any day now, the company will disclose results from a Phase 3 study testing whether its drug, APL-2, can benefit PNH patients already treated with Alexion Pharmaceuticals’ blockbuster Soliris.
  • Rubius Therapeutics, after a handful of delays, has promised to deliver the first data from its clinical trials to transform red blood cells into drugs against cancer and rare diseases. The one-time unicorn had a difficult 2019, and its plans for a turnaround in sentiment hinge on starting 2020 with some positive news.
  • The other big question for Biogen should get resolved. The company’s best-selling medicine, a multiple sclerosis treatment called Tecfidera, is the subject of a patent challenge from Mylan, one that could be settled in the early weeks of 2020. At stake is whether Tecfidera goes generic in 2021 or 2028. The drug accounts for about one-third of Biogen’s revenue, making this more than a minor patent squabble.

Congress is gridlocked on drug pricing. States, not so much

The end of 2019 saw the seemingly bipartisan issue of rising drug costs fall victim to congressional infighting. But where federal legislators have run into roadblocks, individual states are poised to test out some novel ideas that could change how medicine is paid for in the U.S.

As STAT’s Nicholas Florko reports, Louisiana and Washington are pushing forward with their so-called Netflix model for treating hepatitis C, one in which they’d pay drug makers a subscription fee for unlimited doses of curative drugs. A handful of states have enacted laws that could significantly rein in pharma’s oft-derided middlemen, and a few are trying to cap the cost of insulin.

Each experiment is reaching into uncharted territory, and it remains to be seen whether the most ambitious state proposals can make a difference for patients. But each presents a chance for the laboratories of democracy to succeed where national lawmakers have stalled.

Read more.

And, finally, limericks

At STAT, we cannot in good conscience say farewell to a passing year until it has been properly enshrined in rhyme.

And so our own Meghana Keshavan has once more transposed 2019’s biggest news in the life sciences into limerick form. There are couplets about CRISPRing embryos, turning pigs into organ farms, legislating drug prices, and the perils of being uBiome.

Read more.

More reads

  • He Jiankui is going to jail. Would the U.S. criminally prosecute a rogue gene-editing researcher? (STAT)
  • This biotech blowup was foretold. (Wall Street Journal)
  • Google AI tool can pinpoint breast cancer better than clinicians, new study suggests. (STAT)
  • As tens of thousands died, FDA failed to police opioids. (New York Times)

Thanks for reading! Until tomorrow,

Thursday, January 2, 2020

STAT

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