Donanemab’s Promise, BIO Wrap and Mass Layoffs

12 Jun 2024
Drug ApprovalAccelerated Approval
The big news of this week so far was Monday’s FDA advisory committee for Eli Lilly’s Alzheimer’s drug donanemab, where the vote was unanimous in support of the anti-amyloid antibody. If approved, donanemab would be a direct competitor of Biogen and Eisai’s Leqembi, but analysts believe there’s plenty of room in the market for both, and even predict that donanemab’s potential approval could be beneficial for Leqembi in the long run by increasing investments in advocacy and infrastructure. The mood was decidedly different from last week’s FDA adcomm, which voted overwhelmingly against approving Lykos Therapeutics’ MDMA-assisted PTSD therapy. Interestingly, that vote came down less an hour before BioSpace Senior Editor Heather McKenzie hosted a panel at BIO where Dan Karlin, chief medical officer at MindMed, said he’d hoped the conversation would have been different. In other conference news, Eli Lilly and partners Boehringer Ingelheim and Zealand Pharma presented mid-stage results for their GLP-1 products in the MASH space at the Congress of the European Association for the Study of the Liver. These companies are eyeing a piece of the MASH market that Madrigal Pharmaceuticals first tapped into earlier this year when its therapy, Rezdiffra, was approved in March. Finally, CBRE published a report on challenges in finding R&D and manufacturing talent, and thousands of layoffs continue to hit the biopharma industry. According to our Layoff Tracker, there have been 14,000 positions cut this year, with BMS and Bayer being the unfortunate leaders, each with more than 1,500 layoffs underway. Still, analysts are optimistic that the second half of 2024 could be better, as an uptick in the financial markets might provide companies with money to spend on growing their workforces. Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.  Heather McKenzie is a senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Follow her on LinkedIn. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn. > Listen on Spotify > Listen on Apple Podcasts > Listen on Amazon Music > Listen on iHeart
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