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The Readout Damian Garde & Meghana Keshavan

As the world stares down the developing threat of antibiotic-resistant superbugs, the sparse pipeline of new antibiotics has become a cause for global concern. In STAT's latest deep-dive report, Ed Silverman explains how the situation developed, why drug makers have backed away from antibiotic research, and how society can address the problem. Buy it here.

Does BIO’s CEO even want to be FDA commissioner?

With the Biden administration moving into its sixth month without a permanent FDA commissioner, there’s a persistent rumor that Michelle McMurry-Heath, leader of the trade group BIO, is on the short list of nominees. But does she even want the job?

STAT’s Nicholas Florko asked McMurry-Heath that very question. And while “it’s incredibly flattering” to be a rumored candidate, she said, “I am not out there looking for another job. I love what we are doing at BIO.” So would she turn it down if Biden asked her to serve? “Hypotheticals are impossible to answer,” she said. “It’s like saying, ‘If you’re going to the moon, what would you take?’ I don’t know.”

On more terrestrial matters, McMurry-Heath also weighed in on the FDA’s controversial approval of the Alzheimer’s disease treatment Aduhelm, the current climate when it comes to drug pricing, and the implications of waiving vaccine patents.

Read more.

The latest SPAC deal values a digital therapeutics company at $1.6 billion

Pear Therapeutics, a company out to become the Amazon Web Services of digital therapeutics, is going public through a SPAC merger that gives it a $1.6 billion valuation.

As STAT’s Mario Aguilar reports, Pear has spent the last eight years making the case to doctors, payers, and regulators that software can be medicine. In 2017, it won FDA clearance for its digital therapy, designed to treat substance abuse disorder, and the company has launched two more products since. 

The grand ambition is to corner the market on software that can treat disease, where Pear believes it has a first-mover advantage. The problem is that the market in question is still in its infancy. Pear has so far struggled to convince payers that its FDA-cleared products are cost-effective, an issue the company plans to rectify with long-term data.

Read more.

Biogen isn’t the only company poised to profit from Aduhelm

Biogen’s $56,000-a-year list price for Aduhelm shocked and aggravated many scientists and public health advocates who question whether the drug indeed works. But that number actually understates the real cost of the Alzheimer’s disease treatment.

That’s because in order to get Aduhelm, patients have to go through PET scans to confirm they have amyloid plaques in their brains, making it a lucrative proposition for manufacturers of the machines and the drug companies that make imaging agents. And, as STAT’s Rachel Cohrs reports, the medical imaging industry is already pressuring lawmakers to help them make the most of the Aduhelm opportunity. 

As it stands, Medicare only covers amyloid PET scans when they’re used in clinical trials, something the industry’s lobby is trying to change. And while the cost of a PET scan makes treatment with Aduhelm more expensive, it could be in insurers interest to pay for the imaging, as a negative scan would save them from spending $56,000 a year.

Read more.

Digital biomarkers sound great — until you look at the evidence

The Covid-19 pandemic was a perfect proving ground for newfangled clinical trial technologies, including wearables that promise to collect key data without the need for an in-person examination. But the evidence supporting so-called digital biomarkers tends to be inconsistent.

As STAT’s Katie Palmer reports, a team of researchers is out to change that. The Duke Clinical Research Institute is working with a company called HumanFirst to rein in all that data and establish some protocols to vet the capabilities of remote sensors and the digital measures they spit out. 

The plan is to design and conduct experiments that can verify whether devices do what they’re supposed to, test whether their readings are accurate, and determine if they have actual clinical utility. That latter question — figuring out which digital measures matter for patient outcomes — is the biggest hurdle facing the field, making the project a potentially pivotal undertaking for digital health.

Read more.

More reads

  • Moderna plans to expand production to make Covid-19 vaccine boosters, supply more countries. (Wall Street Journal
  • Study confirms GSK-Vir antibody drug reduces hospitalization, death in Covid-19 patients. (Reuters)
  • Amarin rebuffed in high court bid to revive Vascepa patents. (Bloomberg)
  • HHS withdraws 340B drug discount opinion amid lawsuits by pharma companies. (STAT+)

Thanks for reading! Until tomorrow,

Tuesday, June 22, 2021

STAT

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