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STAT+: FDA’s evolving view of what makes a ‘breakthrough’ device

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

Good morning health tech readers!

On top of being a day for brands to post “pranks” on social media, April 1 was also the deadline to apply for the CMMI ACCESS Model’s first cohort. Did you apply? Decide not to? Let me know: mario.aguilar@statnews.com

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You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

Good morning health tech readers!

On top of being a day for brands to post “pranks” on social media, April 1 was also the deadline to apply for the CMMI ACCESS Model’s first cohort. Did you apply? Decide not to? Let me know: mario.aguilar@statnews.com

Continue to STAT+ to read the full story…

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BioNTech to shutter Singapore HQ after ‘comprehensive review’   

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BioNTech, in a move to streamline its operations, is set to close its factory in Singapore that it bought from Novartis just over three years ago.

The facility at the Tuas Biomedical Park, which employs …

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STAT+: Merck’s experimental HIV prevention pill could be made for less than $5 a year, researchers say

An experimental HIV prevention pill being developed by Merck could be mass produced for less than $5 per patient a year according to a new analysis. Advocates argue the low cost means the company should find it easier to license the drug so that low- and middle-income countries can gain easy access.

The pill, dubbed MK 8527, is currently undergoing a pair of late-stage clinical trials that are expected to determine whether the medicine can lower HIV transmission when given to people at high risk of infection. The results are due in the latter half of 2027, according to ClinicalTrials.gov.

Already, the pill is generating considerable interest after Merck released mid-stage results last summer showing its drug holds promise. In addition to being safe and effective, the study found it could protect against infection, a form of prevention known as pre-exposure prophylaxis or PrEP, within 24 hours after being taken. Merck noted the pill works in a novel way.

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An experimental HIV prevention pill being developed by Merck could be mass produced for less than $5 per patient a year according to a new analysis. Advocates argue the low cost means the company should find it easier to license the drug so that low- and middle-income countries can gain easy access.

The pill, dubbed MK 8527, is currently undergoing a pair of late-stage clinical trials that are expected to determine whether the medicine can lower HIV transmission when given to people at high risk of infection. The results are due in the latter half of 2027, according to ClinicalTrials.gov.

Already, the pill is generating considerable interest after Merck released mid-stage results last summer showing its drug holds promise. In addition to being safe and effective, the study found it could protect against infection, a form of prevention known as pre-exposure prophylaxis or PrEP, within 24 hours after being taken. Merck noted the pill works in a novel way.

Continue to STAT+ to read the full story…

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Opinion: STAT+: Former Geisinger CEO: U.S. health systems must replace huge numbers of people with AI 

About 20 years ago, I stepped on stage at one of our Geisinger town halls and looked out upon a sea of people: thousands of full-time employees at an integrated health system charged with the health and well-being of millions of Pennsylvanians. 

Only a fraction of the people in that room were clinicians. 

That was the first time I fully visualized the problem: We employed more people in our revenue cycle department to process bills and reconcile data than we did doctors. And we weren’t alone. It’s the same story at every health system in America, large and small, and over the past two decades, the ratio has become dramatically more disparate. 

Continue to STAT+ to read the full story…

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About 20 years ago, I stepped on stage at one of our Geisinger town halls and looked out upon a sea of people: thousands of full-time employees at an integrated health system charged with the health and well-being of millions of Pennsylvanians. 

Only a fraction of the people in that room were clinicians. 

That was the first time I fully visualized the problem: We employed more people in our revenue cycle department to process bills and reconcile data than we did doctors. And we weren’t alone. It’s the same story at every health system in America, large and small, and over the past two decades, the ratio has become dramatically more disparate. 

Continue to STAT+ to read the full story…

Read More

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