Pharma Pulse: FDA Launches Pre-Check Program, GSK Secures mRNA Settlement, and Pharma Leaders Eye US Investment Boost

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 three developments shaping the pharmaceutical landscape—from regulatory innovation to high-stakes IP settlements and potential policy shifts out of Washington.

The FDA has rolled out its new PreCheck program, aimed at improving drug manufacturing resilience in the US The initiative allows manufacturers to undergo an early, proactive quality systems review—before production even begins.

This approach is designed to reduce inspection delays, strengthen supply chain reliability, and ensure timely patient access to essential medicines. It’s a shift from reactive inspections to preventive oversight, which could be critical for minimizing shortages and maintaining consistent drug quality.

In the business arena, GSK has secured a major settlement in an mRNA patent dispute involving CureVac, Pfizer, and BioNTech. The agreement nets GSK $370 million upfront and lowers the royalties it will pay on future mRNA vaccines developed with CureVac.

The resolution clears the path for both companies to advance their pipelines without the drag of ongoing litigation. Analysts see it as a positive for GSK’s mRNA ambitions, potentially improving profitability on upcoming vaccine launches, and as a sign that mRNA IP disputes may increasingly be resolved through negotiated settlements. Meanwhile, CureVac is also expected to receive $370 million at acquisition closing and $50 million from GSK for monetizing a portion of US product royalties that are due under its existing license agreement that was announced in July 2024.

Looking to policy, President Donald Trump is set to meet with pharmaceutical industry executives to discuss strategies for boosting domestic drug manufacturing and R&D investment. While details of the proposals have not yet been released, the meeting reflects a renewed focus on bolstering US pharma competitiveness, from supply chain security to innovation incentives.

Industry watchers will be paying close attention to whether the discussions lead to concrete policy measures—such as tax incentives, regulatory streamlining, or public-private partnerships—that could influence investment flows and production capacity in the years ahead.

From the FDA’s proactive quality program to a high-profile mRNA settlement and potential policy shifts aimed at strengthening US pharma, these developments underscore how regulation, business strategy, and government engagement are converging to shape the industry’s future.

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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