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Morning. At the moment, we focus on how Duchenne sufferers and their households are responding to the shelving of Sarepta Therapeutics’ gene remedy, see an FDA panel made up largely of SSRI skeptics lambast their use in being pregnant, and extra.
The necessity-to-know this morning
- European regulators stated Sarepta Therapeutics’ Duchenne muscular dystrophy gene remedy shouldn’t be accredited, additional imperiling the way forward for the remedy, which can also be dealing with growing scrutiny within the U.S. Roche has industrial rights to the gene remedy, referred to as Elevidys, in Europe and different international locations.
- European regulators stated Eli Lilly’s Alzheimer’s remedy Kisunla must be accredited for a choose group of sufferers, altering course from an preliminary advice to reject the drug.
- Bristol Myers Squibb named Cristian Massacesi as its new chief medical officer. Massacesi is a phyisican and most lately served as chief medical officer at AstraZeneca and its Alexion unit. He replaces Samit Hirawat, who served as Bristol’s CMO for the previous six years.
Households devastated after FDA halts Sarepta gene remedy
Households of boys with Duchenne muscular dystrophy had been devastated when the Meals and Drug Administration requested Sarepta Therapeutics to halt shipments of its gene remedy, Elevidys, citing security issues — and the corporate subsequently agreed earlier this week. Mother and father who had fought for months to safe entry at the moment are caught in limbo, with appointments abruptly canceled and little communication from regulators, STAT’s Jason Mast reviews.
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