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STAT+: Pharmalittle: We’re watching Europe shifting to reject Elevidys, a FDA panel on SSRI dangers, and extra


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Good morning dearest readers, that is Allison, filling in for Mr. Pharmalittle. I’m coming to you with just a little little bit of espresso envy — yesterday, one of many traders I observe on LinkedIn revealed that he was just lately capable of purchase a La Marzocco espresso machine from a startup that was going out of enterprise. These machines begin at $5,000 and might value as much as $30,000. How a lot did he pay? Simply $600. What’s the most effective deal you’ve gotten on a kitchen equipment? Shoot me an e-mail. Now, on to the information.… 

European regulators on Friday mentioned {that a} Duchenne muscular dystrophy gene remedy shouldn’t be accepted, additional imperiling the way forward for the therapy that can be going through rising scrutiny within the U.S., STAT reviews. The information comes as the way forward for the drug, Elevidys, is in jeopardy after affected person deaths. Elevidys shipments had been halted within the U.S. on Monday, on request from the Meals and Drug Administration.

We should still be awaiting the FDA’s resolution, however the European Medicines Company reapproved GSK’s blood most cancers drug Blenrep on Thursday, in keeping with the Monetary Occasions. The drug was faraway from sale in 2023 as a result of a trial failed to point out it was superior to different remedies. There have additionally been considerations that the drug causes blurred imaginative and prescient. Final week, FDA advisers concluded that the dangers outweighed the advantages proven in trials. 

Proceed to STAT+ to learn the total story…