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In today's Pharmaceutical Executive Daily, FDA staff release briefing documents flagging evidence gaps in Moderna's mRNA flu vaccine, a pharma roundup covers Merck's $510 million collaboration with Protillion Biosciences and Jazz Pharmaceuticals' multi-program antibody discovery deal with AbCellera, and Jack McFeely argues that behavioral and engagement insights are the missing ingredient in patient support programs that struggle to sustain long-term persistence.
FDA scientists have raised significant questions in briefing documents released ahead of a June 18 Vaccines and Related Biological Products Advisory Committee vote on Moderna's mRNA influenza vaccine mFlusiva, flagging evidence gaps in the populations at highest absolute risk of severe flu complications, including immunocompromised patients and very frail older adults who were excluded from the studies underpinning the application, as well as the absence of co-administration data with Covid-19, RSV, and pneumococcal vaccines. The briefing also noted that the confidence interval for mFlusiva's efficacy against the influenza B/Victoria strain crossed zero due to low case accrual, leaving its protective effect against that strain uncertain. Despite the concerns, FDA staff concluded there were no major deficiencies with the application and Moderna is pursuing a bifurcated regulatory pathway seeking traditional approval for adults 50 to 64 based on clinical efficacy data, and accelerated approval for adults 65 and older based on immunogenicity comparisons with Fluzone High-Dose.
Two AI-powered drug discovery collaborations signal continued investment in platform-level partnerships. Merck has entered a multi-target discovery collaboration and license agreement with Protillion Biosciences to deploy Protillion's Prot-MaP platform, in a deal eligible for up to $510 million in research, development, and commercial milestone payments. Separately, Jazz Pharmaceuticals has signed a multi-program antibody discovery agreement with AbCellera, pairing Jazz's oncology pipeline expertise with AbCellera's T-cell engager discovery platform to develop novel multispecific antibodies designed to drive targeted immune activation against difficult-to-treat cancers.
Finally, Jack McFeely argues that biopharma companies can meaningfully improve therapy persistence in patient support programs by incorporating behavioral and engagement insights into program design rather than treating support as a static service offering. McFeely contends that understanding how and when patients engage or disengage with support touchpoints makes it possible to design more personalized interventions that address the specific behavioral and emotional drivers of dropout, and that the shift from one-size-fits-all hub models to data-informed engagement strategies represents the most reliable near-term path to improving long-term outcomes at the patient level.
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