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Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
Several crucial trial readouts in diabetes and obesity will come this year and next, and the stakes are high.
Private Company Edition: Lilly will open a third accelerator, this time in San Diego, and Fosun partnered with Treehill to help later-stage firms get over the finish line. Also, Flagship – after recent UK investments – signals its next fund will total $3bn. ArrivoBio and Alto Neuroscience raised $45m each.
Starting off with MSD as an anchor partner, Aurobindo plans to eventually spar with the likes of WuXi and Lonza while building scale for its biologics CDMO business. Meanwhile, EMA approval for a greenfield project in China and an US FDA nod for Ryzneuta, licensed from Yifan’s Evive Biotech, signal a boost.
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