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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…

Read More

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Moderna’s mRNA flu shot wins unanimous support at FDA adcomm in rebuke of former leadership

Moderna’s mRNA flu shot wins unanimous support at FDA adcomm in rebuke of former leadership

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The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.​ ​Read More

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Memento brings home $93M series A souvenir, picks up bispecific for eye diseases

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Memento’s lead asset is a bispecific antibody that blocks VEGF and activates Tie2. The biotech plans to test the candidate in retinal conditions such as neovascular age-related macular degeneration and diabetic macular edema.

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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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