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 shaping up. As always, we plan to promenade with the official mascots and catch up on our reading, although we also expect to entertain a traveler. On that note, we are planning another listening party, where the rotation will likely include this, this, this, this, and this. And what about you? Summer is nearing an end, but there is still time to gaze at the ocean, bob on a lake, or hike a winding trail. You could also walk the city streets and, if you pause for a moment, watch the world go by. Or you could simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U.S. and across the world, the Associated Press has found. An analysis of U.S. Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic, raising the risks of contamination and other issues in drugs used by millions of Americans. The firms that are overdue for safety and quality inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and previously underwent FDA review before May 2019.
An Eli Lilly insulin engineered for once-weekly dosing now has preliminary results from two more pivotal studies showing the injection was comparable to once-daily insulin, a new slate of data that brings the experimental insulin closer to competing with a Novo Nordisk product that is already commercially available in some parts of the world, MedCity News writes. This experimental insulin is being studied in a broad Phase 3 program spanning five studies — four in type 2 diabetes and one in type 1 diabetes. In total, about 4,000 adult participants are enrolled. The results announced Thursday are from two type 2 diabetes studies; one enrolled participants using basal (long-acting) insulin for the first time and the other enrolled those switching over from daily basal injections.
