Sarepta, Eli Lilly, SSRI results, NIH, Bristol
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Morning. Right now, 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 accepted, additional imperiling the way forward for the therapy, which can also be going through rising scrutiny within the U.S. Roche has business rights to the gene remedy, known as Elevidys, in Europe and different international locations.
- European regulators stated Eli Lilly’s Alzheimer’s therapy Kisunla must be accepted 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 not too long ago 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 are actually caught in limbo, with appointments abruptly canceled and little communication from regulators, STAT’s Jason Mast reviews.
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