STAT+: Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more

Good morning dearest readers, this is Allison, filling in for Mr. Pharmalittle. I’m coming to you with a little bit of coffee envy — yesterday, one of the investors I follow on LinkedIn revealed that he was recently able to buy a La Marzocco espresso machine from a startup that was going out of business. These machines start at $5,000 and can cost up to $30,000. How much did he pay? Just $600. What’s the best deal you’ve gotten on a kitchen appliance? Shoot me an email. Now, on to the news.… 

European regulators on Friday said that a Duchenne muscular dystrophy gene therapy should not be approved, further imperiling the future of the treatment that is also facing increasing scrutiny in the U.S., STAT reports. The news comes as the future of the drug, Elevidys, is in jeopardy after patient deaths. Elevidys shipments were halted in the U.S. on Monday, on request from the Food and Drug Administration.

We may still be awaiting the FDA’s decision, but the European Medicines Agency reapproved GSK’s blood cancer drug Blenrep on Thursday, according to the Financial Times. The drug was removed from sale in 2023 because a trial failed to show it was superior to other treatments. There have also been concerns that the drug causes blurred vision. Last week, FDA advisers concluded that the risks outweighed the benefits shown in trials. 

Continue to STAT+ to read the full story…