Pharma Pulse 5/12/25: FDA Chief Martin Makary Sets June Deadline for GenAI Rollout, Moderna’s Flu-COVID Vaccine Beats Standard Shots

FDA chief Martin Makary sets June deadline for genAI rollout

FDA Commissioner Martin Makary has set a June 30, 2025 deadline for full agency-wide rollout of generative AI to streamline scientific reviews and reduce bureaucratic workload, amid concerns about whether the technology can offset recent staffing cuts under HHS Secretary Robert F. Kennedy Jr.

Moderna’s flu-COVID vaccine beats standard shots: Study

Moderna’s combination flu-COVID vaccine, mRNA-1083, generated stronger immune responses than standard vaccines in adults over 50 during a large phase 3 trial, according to results published in JAMA Network.

Bridging the Gap: A Large Pharma Blueprint

In a Pharmaceutical Executive article, David Kamenir outlines a five-step blueprint for large pharmaceutical companies to develop and execute resilient, growth-driven strategies by clarifying intent, empowering teams, and maintaining adaptability while avoiding overly cautious decision-making that can hinder innovation.

The Potential for Stricter Regulations in Vaccine Trials

In a recent Applied Clinical Trials interview, Krinx Kong, CCO, Cognivia, warned that potential stricter regulations in vaccine trials could complicate recruitment and retention, emphasizing the need for behavioral insights, flexibility, and communication to address patient hesitations and reduce dropouts.

US, UK reach deal on tariffs, market access

The US and UK have reached a trade agreement under the Trump administration that maintains a 10% US tariff on British imports while lowering UK tariffs on US goods, sets quotas on automobiles and metals, and expands US market access for agricultural and industrial exports.