Oct 23, 2019

Biogen's Alzheimer's revival meets with skepticism

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Data: Money.net; Chart: Axios Visuals

Biogen was a shattered biotech company in March after it pulled the plug on its new Alzheimer's drug, but it recaptured Wall Street's good graces by looking at its data again and deciding to shoot for FDA approval after all.

Reality check: Alzheimer's affects almost 6 million Americans, and those patients and their families have desperately sought an effective treatment. But independent experts have not reviewed Biogen's data, and the industry isn't exactly on good footing right now when it comes to being forthright about its data.

What they're saying: Many stock traders are skeptical of Biogen's new Alzheimer's claims, Stat reported.

  • One of the two large clinical trials still failed.
  • Everything depends on whether patients actually improved their cognitive functions on higher doses of the drug, called aducanumab.

Yes, but: That skepticism doesn't mean the drug won't get FDA approval.

  • The FDA has shown a willingness recently to approve drugs, sometimes controversially, if they treat conditions with a dearth of options and if companies agree to conduct post hoc studies.

The big picture: The public should always be skeptical of drug company data and claims — especially with this drug, and in the industry's current state.

  • Any drug treating Alzheimer's would greatly alter society, both clinically and financially, so there's a lot of pressure to get something like this right.
  • There's also a lot of pressure to make sure drug companies aren't manipulating the results. Novartis recently got approval for Zolgensma, the world's most expensive drug, but the FDA later found out the company's data was faulty — and Novartis knew about it.

Go deeper: The outlook for Alzheimer's research keeps getting bleaker

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A drug pricing method that values the price of a life gets new attention

Illustration: Eniola Odetunde/Axios

A drug pricing model used by other countries but long opposed by drugmakers in the U.S. is getting new attention amid the political debate over drug prices, the Wall Street Journal reports.

How it works: The method, pushed by the Institute for Clinical and Economic Review, "puts a dollar figure on a year of healthy life, calculates how much health a drug restores to a sick patient, then prices drugs accordingly," per the Journal.

Go deeperArrowNov 5, 2019

FDA committee recommends withdrawing Makena for preterm birth prevention

An FDA advisory committee yesterday voted to recommend that Makena, a treatment to prevent women from having a preterm birth, be withdrawn from the market after a study found that it's ineffective, the Wall Street Journal reports.

Backdrop: The FDA approved the drug in 2011, but required a follow-up study. That study came out last week and found that the drug — which has become the standard treatment — doesn't decrease recurrent preterm births.

Go deeperArrowOct 30, 2019

Elizabeth Warren's dream health care world

Illustration: Aïda Amer/Axios

Sen. Elizabeth Warren's Medicare for All plan takes on every major health care industry — insurers, doctors, hospitals and drug companies — in her pursuit of expanding coverage and lowering costs for the middle class.

Why it matters: We've never tried any cost containment measures that are remotely close to being as aggressive as Warren's, and there could be consequences if payment rates are slashed so low.

Go deeperArrowNov 4, 2019