Hello, everyone, and how are you this morning? We are doing just fine, thank you, courtesy of a warm and shiny sun enveloping the leafy Pharmalot campus. Our short people have left for their destinations, our official mascot has tired himself out and is now snoozing in a corner, and we are left with a beckoning coffee pot that is waiting to be fired up. And so, on with the show. Here are a few tidbits to help on your journey. We hope your day is productive and also meaningful. Why not add a little zen now and then? Good luck and keep in touch. …
The Food and Drug Administration approved a medicine from Jacobus Pharmaceuticals, a small, family-run company, for treating a neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS, for children ages 6 to 17, STAT reports. The move potentially adds unforeseen competition for Catalyst Pharmaceuticals (CPRX), which last December won an FDA endorsement to market a treatment for adults. The approval adds an unexpected twist to a simmering controversy over a rare disease drug that briefly became a poster child for high-priced medicines.
The Senate Judiciary Committee is holding a hearing this morning to discuss intellectual property and prescription drug prices. The session is notable because a Republican-led committee is holding the hearing. As one of our colleagues notes, typically, the Republican Party has been deferential to the pharmaceutical industry when it comes to intellectual property protection and patent exclusivity. However, there is growing criticism of so-called patent thickets and pay-to-delay deals stemming from patent settlements, which can delay lower-cost generic alternatives.
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