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STAT+: Her daughter Mila got a bespoke medicine. Now she’s starting a new biotech to make more

ROME — Julia Vitarello, whose daughter Mila eight years ago received a bespoke medicine designed for her particular disease-causing mutation, said this week that she is in the process of starting a new company to try to create these individualized therapies at scale.

Vitarello’s previous effort, called EveryONE Medicines, recently folded in part because new Food and Drug Administration guidance encouraging the development of customized therapies did not go far enough in creating a pathway to satisfy EveryONE’s investors, Vitarello said. 

Now Vitarello and collaborators are looking for new funders. 

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ROME — Julia Vitarello, whose daughter Mila eight years ago received a bespoke medicine designed for her particular disease-causing mutation, said this week that she is in the process of starting a new company to try to create these individualized therapies at scale.

Vitarello’s previous effort, called EveryONE Medicines, recently folded in part because new Food and Drug Administration guidance encouraging the development of customized therapies did not go far enough in creating a pathway to satisfy EveryONE’s investors, Vitarello said. 

Now Vitarello and collaborators are looking for new funders. 

Continue to STAT+ to read the full story…

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Tennessee pharmacies sell potent ivermectin, led by anti-vaccine doctor who’s taken ‘bucketloads’

The drug is now marketed and sold across the state in roadside shops and small-town strip malls with little oversight from health authorities. Highway billboards advertise ivermectin as “Available Without a Prescription in Tennessee!” while dozens of pharmacies offer highly concentrated pills, sometimes at 10 or 20 times the potency of a standard tablet.

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The drug is now marketed and sold across the state in roadside shops and small-town strip malls with little oversight from health authorities. Highway billboards advertise ivermectin as “Available Without a Prescription in Tennessee!” while dozens of pharmacies offer highly concentrated pills, sometimes at 10 or 20 times the potency of a standard tablet.

Read the rest…

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FDA’s new voucher program hints at broader policy agenda, making many ‘uncomfortable’

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While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Review voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.

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STAT+: CMS recalculates Medicare Advantage star ratings again, adding more volatility to program

Federal officials have recalculated the quality ratings for 2026 Medicare Advantage plans, a new government memo shows. The consequential decision was prompted by yet another legal action from the health insurance industry.

Over the past few years, health insurance companies that sell Medicare Advantage plans have inundated the Centers for Medicare and Medicaid Services with lawsuits that challenged their lower star ratings, which jeopardized taxpayer-funded bonuses. Many insurers have lost their cases, but a handful have won. Two years ago, CMS had to redo Medicare Advantage star ratings after federal judges said the government erred with its original calculations.

Medicare Advantage plans that get at least four out of five stars get bonus payments. Those bonuses have ballooned to $16 billion this year — almost the entire budget of the Centers for Disease Control and Prevention and an amount that has doubled since 2020

Continue to STAT+ to read the full story…

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Federal officials have recalculated the quality ratings for 2026 Medicare Advantage plans, a new government memo shows. The consequential decision was prompted by yet another legal action from the health insurance industry.

Over the past few years, health insurance companies that sell Medicare Advantage plans have inundated the Centers for Medicare and Medicaid Services with lawsuits that challenged their lower star ratings, which jeopardized taxpayer-funded bonuses. Many insurers have lost their cases, but a handful have won. Two years ago, CMS had to redo Medicare Advantage star ratings after federal judges said the government erred with its original calculations.

Medicare Advantage plans that get at least four out of five stars get bonus payments. Those bonuses have ballooned to $16 billion this year — almost the entire budget of the Centers for Disease Control and Prevention and an amount that has doubled since 2020

Continue to STAT+ to read the full story…

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