CDC Faces Critical Meetings Amid COVID Vaccine Uncertainty, Plus Deals, FDA Approvals, More

We returned from the Labor Day holiday to a spate of intriguing deals, including two that could surpass $2 billion: Vertex’s new pact with Enlaza for autoimmune disease—which the Casgevy maker hopes could ease conditioning for the sickle cell/beta thalassemia gene therapy—and Novartis’ agreement with Arrowhead for neurodegenerative diseases such as Parkinson’s. 

 

But as we look ahead, Thursday’s Senate Finance Committee will be the focus this week, as Health and Human Services Secretary Robert F. Kennedy Jr. will answer questions after the ousting of CDC Director Susan Monarez. Her departure is reportedly linked to changes to the regulation of COVID-19 vaccines, for which the FDA last week issued restricted approvals to Moderna, Pfizer/BioNTech and Novavax and rescinded the emergency use authorizations. The next ACIP meeting—where COVID-19 vaccines will be on the agenda—is set for Sept. 18 and 19.  

 

In the weight loss arena, Novo Nordisk presented results from a real-world study this weekend at the European Society of Cardiology Congress in Madrid showing that Wegovy cut the risk of heart attack, stroke or death by 57% compared to Eli Lilly’s tirzepatide in people with obesity and cardiovascular disease. The company also continues to throw money into the space, last week inking a $550 million deal with Replicate for RNA-based treatments for obesity and diabetes. Meanwhile, Lilly is dropping studies of one oral obesity candidate as another nears a regulatory filing. Finally, the FDA greenlit the first GLP-1 generic for obesity.  

 

We also discuss reactions to the FDA’s new guidance on radiopharma drug development, four recent approvals for rare diseases, and everything you ever wanted to know about SPACs.