Good morning, and welcome to a spooky edition of Pharmalittle. It’s Jason Mast here, filling in for Ed. Nothing too scary on the docket — unless you consider broken partnerships and spurned FDA applications scary — but I have dropped a Reese’s cup in my coffee this morning, which, for bean purists, is probably a little frightful. Happy Halloween and onto the news:
FDA advisers unanimously spurned an experimental drug for rare pediatric brain cancer, Endpoints News tells us. The company behind the drug, Y-Mabs, had released data showing it led to a three-year-survival rate of 54% in a study. But that study had no control group, and the agency and the company disagreed sharply on whether it showed patients were really living longer than standard of care. A committee of advisers agreed, voting 16-0 to recommend rejecting the drug.
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