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The Readout Damian Garde

Biotech’s hubris is backfiring

Welcome to Monday. As the week begins, let us take a moment to remember the dumpster fire that was last week — at least in biotech.

The FDA chastised Novartis for withholding information that its employees had manipulated its some data on Zolgensma. Nektar Therapeutics shares cratered after it disclosed manufacturing problems for an experimental clinical trial cancer drug; Amarin said that the FDA would hold an advisory committee meeting on Vascepa, after all, causing its shares to crash, too.

What's going on? There’s a crisis in biotech credibility these days, writes STAT’s Matthew Herper, fueled by boom-era hubris. Rather than underpromising, the industry is overpromising starry-eyed investors and now paying the price.

Read more.

AI offers a glimmer of hope for Alzheimer’s

Scientists may heading back to the drawing board with drug targets for Alzheimer's, but they seem to be homing in on powerful new diagnostic tools in the meantime.

Some tangible progress seems to be underway in the field of artificial intelligence: Some scientists have developed algorithms that help parse the different forms of amyloid plaque, while others have developed machine learning tools that analyze medical images to predict the onset of the disease — potentially years before symptoms even begin.

Last week, MIT researchers unveiled AI that could predict, two years in advance, which patients might flunk a test that’s used to measure cognitive decline.

Read more.

Amgen wins a lawsuit ... yet again

Amgen, the law firm with a drug-making side gig, scored another big legal victory. Late Friday, a federal judge in New Jersey ruled in Amgen’s favor in a lawsuit brought to defend the validity of two patents covering the blockbuster psoriasis drug Enbrel. The defendant in the case was Sandoz, the generics arm of Novartis, which was trying to launch a biosimilar version of Enbrel.

The ruling means Sandoz can’t start selling its Enbrel biosimilar in the U.S. until 2029, instead of 2021, which would have been the case had the judge decided against Amgen. Enbrel was first approved in 1998 and its original patent expired in 2012, but a thicket of subsequently filed (and granted) patents has protected the antibody drug from domestic biosimilar competition. Sandoz’s Enbrel biosimilar was approved here three years ago, but still sits on a shelf.

Enbrel accounts for about one-fifth of Amgen’s total revenue, so the ruling means the drug will continue to deliver meaningful cash flow for an additional eight years. Enbrel sales are still falling each year, but thanks to Amgen’s lawyers — and a New Jersey judge — those sales will decline slower than they could have.

Canada isn't so keen on sharing its drugs

In an effort to lower U.S. drug prices, the Trump administration has said it will import some medications from Canada — where prescription costs are considerably lower.

One hitch: Canadians are furious. And some are trying their darnedest to stop it, write STAT’s Nicholas Florko and Lev Facher. The biggest concern is that such imports could exacerbate an already critical shortage of many drugs in Canada.

“You are coming as Americans to poach our drug supply, and I don’t have any polite words for that,” Amir Attaran, a professor at the University of Ottowa, told STAT. (He also called the plan “deplorable” and “atrociously unethical.”

“Our drugs are not for you, period,” he said.

Read more.

More reads

  • Don't change your DNA at home, says America's first CRISPR law (MIT Technology Review)
  • For rules on creating 'CRISPR babies' from edited embryos, scientists call a do-over (STAT)
  • Autolus delays multiple CAR-T clinical programs (Fierce Biotech)

Thanks for reading! Until tomorrow,


Monday, August 12, 2019


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