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 fairly modest. We hope to catch up on our reading, spend time with our Pharmalot ancestor, and promenade with the official mascots. We also hope to hold another listening party, where the rotation will likely feature this, this, this, and this. And what about you? This is a grand time to enjoy the great outdoors. Beaches and lakes are beckoning. City streets want to be strolled. And woods are inviting the adventurous for long mysterious walks. Take your pick. Or you could simply hide indoors and binge-watch something on the telly. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
A European Medicines Agency committee that evaluates new drugs recommended that an Alzheimer’s therapy from Eisai and Biogen should be rejected, again diverging from their U.S. counterparts on a medicine for a condition where treatments are desperately needed, STAT tells us. The committee determined that the benefits of the drug, called Leqembi, did not outweigh the risks of potentially dangerous side effects. A final decision rests with the European Commission, which almost always follows EMA recommendations. A key concern has centered on a side effect called ARIA, a brain swelling or bleeding that can be fatal in rare cases.
The European Medicines Agency backed the use of Novo Nordisk’s Wegovy to lower major heart risks and strokes in overweight or obese adults without diabetes, Reuters notes. The endorsement from the European Union drug watchdog’s committee comes two days after Wegovy secured a similar nod from the U.K. regulator, while the U.S. Food and Drug Administration approved the drug for prevention of cardiovascular events in people with obesity earlier this year. Novo plans to add the prescribing information on the Wegovy label in the EU within about one month.
