Moderna received a refusal-to-file (RTF) letter for its next-generation mRNA flu vaccine, the FDA citing concerns over the trial’s control arm design. Analysts warn the decision may complicate Moderna’s flu-COVID combination strategy, with policy shifts suggesting increased scrutiny of mRNA platforms in the U.S.

We've had Eyes on the evolving Pharma Pipeline Strategy. This week we highlight how many companies are leaning on external innovation with full acquisition s to targeted asset deals to drive long-term strategy.

In Part 4 of our Series on how the pharma landscape is being reshaped - from the inside out, we have Eyes On what late-stage setbacks and tolerability trade-offs reveal about portfolio planning and platform expansion.

In Part 3 of our Series on how the pharma landscape is being reshaped - from the inside out - we have Eyes On where late-stage clinical execution is still cutting through uncertainty as de-risked assets redefine standards of care and company trajectories.

In Part 2 of our Series on how the pharma landscape is being reshaped - from the inside out, we have Eyes On how policy and regulation are redefining pricing, access, and market stability.

In Part 1 of our Series on how the pharma landscape is being reshaped - from the inside out, we have Eyes On how cost discipline, manufacturing shifts, and portfolio resets are reshaping large pharma.