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 filling up quickly. Besides tidying up around the Pharmalot grounds, we plan to escort our shortest person to an institution of higher learning for a look-see, and catch up on our reading. We may even have time to squeeze in another listening party, where the rotation just might include this, this, this, this and this. And what about you? As colder temperatures set in, this is a fine time to bundle up and breathe in some fresh outdoor air. Toward that end, you could bolster the economy and purchase a sweater or two, or whatever else you may need, since tariffs may be imposed at some point. You remember this expression: Hurry, act now. You could plan a holiday getaway. Or simply reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved, saying that the benefits of the treatment outweigh the risks in a select group of patients, STAT explains. A European Medicines Agency committee had said last July that the medicine, called Leqembi, should be rejected, citing the modest benefits seen in trials and the potentially dangerous side effects that accompany the drug. But following an appeal from the companies, through a re-examination process, the committee on Thursday said it had concluded that, for certain patients, “the benefits of Leqembi in slowing down progression of symptoms of the disease are greater than its risks.” The final approval decision rests with the European Commission, but it almost always follows EMA guidance. Only roughly one in four re-examination requests are successful.
Eli Lilly filed a lawsuit accusing the U.S. Health Resources and Services Administration of blocking its plan to change reimbursement to hospitals under the federal 340B Drug Discount Program, which was created to help hospitals and clinics care for low-income and rural patients. The company maintained that its plan would pay cash directly to 340B hospitals, ensuring they pay no more than the ceiling price called for in the program. Lilly also argued the HRSA, which is part of the U.S. Health and Human Services Department, rejected the model by insisting that it was inconsistent with federal law governing the 340B program. This is the second such lawsuit filed by a large drug company against HRSA over proposed payment terms. Earlier this week, Johnson & Johnson sued the agency over plans to pay rebates to hospitals for two widely prescribed medicines. Drugmakers must participate in the 340B program in order to receive funds from government health insurance programs like Medicare and Medicaid.
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