STAT+: Pharmalittle: We’re reading about Pfizer halting GLP-1 work, FDA use of contractors, and more
Pfizer said it would stop development of danuglipron, its experimental oral GLP-1 medicine to treat obesity
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and refreshing because, once again, that predictable routine of meetings, deadlines, and the like has returned. After all, the world keeps spinning. And to cope, yes, we are relying on cups of stimulation to help us along. Our choice today is pumpkin spice. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to get you going. Hope your day is simply smashing, and do keep in touch. We enjoy your notes and dossiers. …
Capping more than two years of stock-gyrating drama, Pfizer said it would stop development of danuglipron, its experimental oral GLP-1 medicine to treat obesity, focusing its efforts on another medicine with a different mechanism of action, STAT writes. The company disclosed that an asymptomatic volunteer in its studies experienced “potential drug-induced liver injury,” which resolved after stopping the medication. After reviewing all clinical data for the medicine and consulting with regulators, Pfizer decided to halt research. The news could worry investors both because of the vast sales potential of obesity medicines and the need Pfizer has to demonstrate progress on its drug research. Pfizer stock has fallen nearly 18% year-to-date and trades at about a third of its pandemic-era peak. Some analysts had expressed optimism about the danuglipron program, based in part on comments by Pfizer executives.
The U.S. Food and Drug Administration is finalizing plans to replace some of the employees it laid off with contractors, after steep cuts to the agency workforce disrupted drug and food safety inspections, CBS News reports. The contractors would effectively replace most of the work done by more than 50 laid-off federal employees who handled travel logistics and conducted oversight on spending for the agency inspectors. The plan was approved by FDA Commissioner Marty Makary. The move appears to contradict what laid-off workers supporting FDA’s Office of Inspections and Investigations had been told in their layoff notices: that they were being let go because their work was “unnecessary or virtually identical to duties being performed elsewhere in the agency.”
