Pharmaceutical Executive Daily: FDA Issues Refusal-to-File Letter to Moderna

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, the FDA issues a refusal-to-file letter to Moderna for its seasonal influenza vaccine as the company secures a long-term agreement in Mexico, industry leaders assess China’s evolving role in global pharma strategy, and the FDA makes a decision on Keytruda in platinum-resistant ovarian cancer.

The FDA has issued a refusal-to-file letter to Moderna for its seasonal influenza vaccine candidate, delaying the regulatory review process. The setback comes as Moderna simultaneously announced a long-term agreement in Mexico, underscoring its broader strategy to expand global vaccine partnerships despite regulatory headwinds in the US.

In a new analysis of China’s shifting pharmaceutical landscape, experts describe the country as both a competitive force and a strategic partner in global drug development. From innovation capacity to regulatory reform and geopolitical tension, China’s evolving role is reshaping sourcing, clinical development, and commercialization decisions for multinational drugmakers.

Finally, the FDA has made a regulatory decision regarding Keytruda in platinum-resistant ovarian cancer, a setting with significant unmet need. The outcome carries implications for checkpoint inhibitor positioning in later-line gynecologic oncology and for Merck’s broader lifecycle strategy.

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