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The Readout Damian Garde & Meghana Keshavan

Where does one acquire diamond hands?

How do pandemics end? And who gets to be a TV media expert?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss Ginkgo Bioworks, the multibillion-dollar biotech company with grand ambitions, a famous ticker symbol, and an affinity for memes. Then, STAT’s Helen Branswell joins us to discuss a topic on everyone’s mind: How will the Covid-19 pandemic end? Finally, we’ll talk about the modern phenomenon of the pandemic celebrity and the case of Ashish Jha, TV’s ever-present Covid-19 expert.

Listen here.

Price competition could finally come to immunotherapy

There are no fewer than seven FDA-approved treatments that target the interlocking PD-1 and PD-L1 proteins to turn the immune system’s attention to tumors. And yet none of the manufacturers has elected to compete on price, with each treatment carrying a list price exceeding $150,000 a year. 

But that could soon change, thanks to the rise of Chinese biotech. This week, the FDA accepted Innovent Biologics’ approval application for a PD-1 treatment partnered with Eli Lilly, promising to make a final decision in March 2022. That’s the first filing for a Chinese PD-1, but it won’t be the last, with BeiGene and Junshi Biosciences moving forward with treatments of their own.

The question, as Cowen analyst Yaron Werber wrote in a note to clients, is just how much of a discount the Chinese manufacturers plan to offer. In China, PD-1 treatments sell for about 10% of their stateside list prices, Werber noted, and if manufacturers bring similar discounts to the U.S., the roughly $16 billion market for checkpoint inhibitors could get significantly roiled.

A heart-shaped mass of stem cells

Stem cell biologists have developed a heart-like organoid, which they’ve aptly dubbed the “cardioid.” The work, published in Cell, didn’t use external scaffolding to provide a framework for heart cells to organize themselves — the typical way that organoids are built. Rather, the scientists coaxed stem cells to morph into heart cells and self-organize into heart muscle structures, STAT’s Shraddha Chakradhar writes. 

The cells, to the scientists’ surprise, assembled into a three-dimensional structure that included a single chamber that resembled what’s found in a human heart. The mass of cells also developed a heartbeat. 

Read more.

Bankruptcy, compassionate use, and ‘a big mess’ for rare disease families

For some families affected by Niemann-Pick type C, a rare progressive genetic disorder, access to an unproven and unapproved drug has been a lifeline. But after a failed clinical trial, a corporate bankruptcy, and a confusing back-and-forth with the FDA, it’s unclear whether they’ll be able to get the medicine.

As STAT’s Ed Silverman reports, the story revolves around adrabetadex, an investigational treatment for Niemann-Pick type C, or NPC. Mallinckrodt, which owns the rights to adrabetadex, had been providing it to patients under a compassionate use policy. But earlier this year, the company ended clinical testing after studies indicated the drug had no benefit. Then, as part of an ongoing bankruptcy, Mallinckrodt sold adrabetadex to a startup, leaving NPC families in limbo.

“I’m scared for the kids,” said Pam Andrews, who has two daughters suffering from NPC. “There’s zero room for error and there’s still so much uncertainty. It seems like a big mess.”

Read more.

More reads

  • To help solve climate change, look to the biosciences. (STAT)
  • Next wave of Covid vaccines is on the way. (Bloomberg)
  • Covid-19's pharma billionaires could vaccinate the world's poor, charities say. (Reuters)
  • ‘Swept under the carpet’: When health records are held ransom, patients are the hardest hit — and last to know. (STAT)

Thanks for reading! More next week,

Damian

Friday, May 21, 2021

STAT

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