And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still in the works. For now, we expect to engage in our usual ritual of promenading with the official mascot, take a drive in the countryside with the radio turned up, and hold another listening party with Mrs. Pharmalot (the rotation will start with this and this). And what about you? This may be a fine time to indulge in a new round of binge-watching on the telly, or you could catch up on your reading. You could challenge friends to play a round of fun facts (did you know on this day in history, George Santos attended FDR’s second inauguration?). Or you could simply take stock of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
The U.S. Food and Drug Administration rejected an Eli Lilly application seeking accelerated approval for donanemab, a treatment for people with early stage Alzheimer’s disease, STAT notes. But Lilly said a planned readout from an ongoing, Phase 3 study of the drug remains on track for the middle of the year, and if positive, will form the basis of an application for full approval “shortly thereafter.” Lilly filed for accelerated approval based on a mid-stage study that showed the drug lowered levels of amyloid. But the FDA rejected the application because the study did not include enough patients who had taken the medicine for at least a year.
Amid rising concern over antibiotic resistance, a battle is brewing in Europe over a proposal to offer vouchers to companies as an incentive to develop new treatments, a controversial idea that has already raised objections from more than a dozen members of the European Union, STAT tells us. A company that wins regulatory approval for a novel antibiotic would get a voucher that can be used to extend for one year exclusive rights to the results of clinical trial data for another medicine. Or a drug maker could sell the voucher to another company. But critics say a large drugmaker could buy a voucher and apply added exclusivity to a pricey medicine, forestalling lower-cost generic competition.
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