Vaccines
The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.
The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.
Improved survival on display at the American Society of Clinical Oncology (ASCO) in Chicago; Pfizer’s unusual pact with China’s Innovent highlights a new type of collaboration; Eli Lilly continues its nonstop deal streak, including with Chinese biotechs; and looking ahead to this weekend’s American Diabetes Association meeting.
Riding a newfound surge of interest on infectious disease concerns, Moderna is linking up with a global vaccine foundation in hopes of developing a vaccine to slow the new surge in Ebola underway in the Congo and Uganda.
FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
The FDA will convene its vaccines advisory panel to discuss seasonal COVID-19 vaccines—a surprise move after Health Secretary and vaccine skeptic Robert F. Kennedy, Jr. overhauled a separate vaccine committee.
Eli Lilly continues to spend its GLP-1 landfall with four new deals in the past week, including three in the vaccine space; the obesity leader also touted surgery-like results for its next-gen weight loss drug; Moderna’s stock climbs on the hantavirus “fear trade”; and in oncology, all eyes are on Revolution at ASCO this week.
Eli Lilly, with a busier-than-ever business development team, has made a major vaccine play‚ months after hiring veteran vaccine regulator Peter Marks following his FDA departure.
After getting slapped with a surprise refuse-to-file letter signed by former CBER Director Vinay Prasad, Moderna’s flu vaccine application will now go before the FDA’s Vaccine advisory committee.
In September last year, a group of concerned stockholders raised alarm about Vaxart’s proposed reverse stock split, which the biotech was pushing for despite strong opposition from shareholders.
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