Good morning, everyone, and how are you today? The heat continues to rise here on the Pharmalot campus, where we are hoping for storm clouds to wash away the humidity that has characterized the past few days. One can dream, yes? To cope, we are quaffing some cups of stimulation — our choice today is butter pecan — and distracting ourselves by foraging for items of interest. Toward that end, we have assembled a few below. Hope you find these helpful and have a cool day. Keep in touch. …
The European Medicines Agency and the heads of medicines agencies in member countries announced several steps to address shortages of GLP-1 drugs. One effort will involve collecting real-world data to see how the drugs are used, because the EMA blamed shortages on prescriptions for “cosmetic weight loss in people without obesity or people with overweight who do not have weight-related health problems.” A working group will also recommend manufacturers increase capacity and ensure their marketing is approved by regulators. The agency noted claims “should alight with rational medicine use and public health goals.”
The U.S. Food and Drug Administration has drafted guidance aimed at getting drug and device makers to enroll more people of color and women in the clinical trials that test whether products work, STAT says. The guidance is long-awaited and is the first step in carrying out a law that Congress passed in 2022. Congress sought to fix the chronic lack of diversity in clinical research by requiring companies to give the FDA their plans for enrolling people who are representative of patients who would take products being tested. Although over 40% of the U.S. population is currently comprised of ethnic and racial minorities, typically only 5% to 10% of trial participants represent any minority group.
