Pharma Pulse: FDA Boosts Transparency, CDC Appoints mRNA Critic, and Genentech Invests $700M in US Manufacturing

August 27, 2025

This episode of Pharma Pulse covers the FDA’s new daily adverse event reporting initiative, the CDC’s appointment of an mRNA vaccine critic to lead its COVID-19 immunization workgroup, and Genentech’s $700 million investment in a North Carolina biologics facility.

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering new steps from the FDA to expand safety transparency, a controversial leadership appointment at the CDC, and Genentech’s latest manufacturing investment in North Carolina.

The FDA will now publish daily updates of adverse event reports for approved drugs and biologics. This move marks a major expansion of transparency, giving researchers, healthcare providers, and the public quicker access to critical safety data. While the reports do not establish causation, the initiative is designed to strengthen pharmacovigilance and improve trust in the agency’s oversight of drug safety.
In other news, the CDC has appointed a physician known for his criticism of mRNA vaccines to chair its COVID-19 immunization workgroup. The decision has sparked debate, with some praising the move as an effort to include diverse scientific perspectives, while others worry it could undermine confidence in vaccination programs. The appointment comes at a pivotal time as public health leaders continue to combat vaccine hesitancy and prepare for the next phase of COVID-19 management.
Lastly, Genentech has broken ground on a new $700 million manufacturing facility in North Carolina. The site will focus on producing biologics and next-generation medicines, reinforcing Genentech’s long-term strategy to expand US-based capacity. The investment is also expected to create hundreds of jobs, bolstering the region’s growing reputation as a hub for advanced pharmaceutical manufacturing.

From expanded FDA transparency to CDC leadership changes and major biotech investment, these developments highlight the intersection of safety, policy, and infrastructure shaping the pharmaceutical industry.

That’s it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access and care delivery, visit pharmaceuticalcommerce.com.

Thanks for listening—until next time, stay well and stay informed.

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