We’re studying about new Novo CEO, FDA reversal on Sarepta

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Rise and shine, one other busy — and steamy — day is on the way in which. We will inform as a result of the official mascots are spending much less time on the dusty Pharmalot grounds and, as a substitute, have curled up by the indoor cool-air machines. As for us, we’re testing the notion {that a} sizzling drink can cool you down. So we’re busy brewing one other cup of stimulation. Our selection is banana break up. Please be happy to hitch us. In the meantime, the time has come to get cracking. So right here is the newest laundry checklist of fascinating objects so that you can peruse. We hope you have got a smashing day and conquer the world. And naturally, do be in contact. …

Novo Nordisk tapped Maziar Mike Doustdar, its head of worldwide operations, as its new chief govt officer and president amid a broader management shakeup throughout the corporate, STAT notes. The present CEO, Lars Fruergaard Jørgensen, introduced he was stepping down in Could as the corporate confronted a tumbling share value and rising competitors from Eli Lilly within the weight problems market. Doustdar begins his new function on Aug. 7 as the corporate struggles to develop into extra aggressive once more. Novo additionally reduce its 2025 development outlook, saying it now expects gross sales to develop from 8% to 14% and revenue to develop from 10% to 16%, whereas its earlier outlook was 13% to 21% and 16% to 24%, respectively. The change was as a consequence of lower-than-expected development expectations for its diabetes drug Ozempic and weight problems drug Wegovy within the U.S. and worldwide markets. The “persistent use” of compounded weight problems medication within the U.S. has been a barrier to market enlargement, the corporate added.

In a pointy reversal, the U.S. Meals and Drug Administration mentioned it was clearing the way in which for Sarepta Therapeutics to renew shipments of its Elevidys gene remedy for Duchenne muscular dystrophy to youthful sufferers who can stroll, STAT says. The announcement comes one week after Sarepta voluntarily halted all shipments of Elevidys, following the deaths of two older boys. The corporate agreed to droop shipments of the gene remedy after initially refusing to abide by an FDA request to take action. A senior FDA official later informed STAT that Sarepta confronted an “arduous and treacherous” path to getting the product again available on the market. The Duchenne affected person neighborhood was angered by the FDA resolution to droop Elevidys for ambulatory sufferers, and that seems to have performed a job within the company reversal. “The affected person neighborhood is a crucial voice, and the FDA will proceed to hearken to and reply to ideas from the neighborhood impacted by DMD,” the company mentioned in a press release.

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