Eyes On the Evolving Pharma Landscape - Part 2

How Policy, Pricing, and Regulatory Volatility are Affecting Pharma Strategy

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.

Executive Highlights

• Drug pricing and access are increasingly being shaped by trade and industrial policy rather than market dynamics alone.

• Regulatory stability is emerging as a differentiator between markets competing for life sciences investment.

• Safety signals and leadership turnover are amplifying uncertainty around approval pathways and label durability.

• Companies are being forced to build flexibility into pricing, regulatory, and launch strategies earlier in development.

Policy & Regulatory are becoming Stronger Influencers

Policy and regulatory risk have long been part of pharmaceutical strategy, but recent developments suggest these forces are exerting a more direct influence on market outcomes. Pricing frameworks, leadership changes at regulatory agencies, and evolving safety standards are increasingly shaping where companies invest, how they price innovation, and which patients gain access to new therapies.

A recent U.S.–U.K. agreement illustrates how drug pricing is becoming embedded in broader economic and trade negotiations. The deal includes tariff preferences for U.K.-origin pharmaceuticals while the U.K. commits to changes affecting how medicines are valued and reimbursed, including reforms to NICE assessment practices.

At the same time, leadership turnover at the U.S. FDA has added uncertainty for sponsors navigating late-stage development and review. Even when formal guidance remains stable, shifts in leadership can influence regulatory culture, enforcement priorities, and review cadence.

Sarepta’s experience with Elevidys underscores how safety signals can quickly reshape commercial opportunity. Following fatal acute liver failure reports in non-ambulatory patients, the FDA narrowed the label and added stronger safety warnings. Sarepta has since pursued protocol updates to test an enhanced immunosuppressive regimen intended to mitigate liver risk and potentially support future label discussions.

Collectively, these developments reinforce that pricing frameworks are increasingly negotiable but less predictable, regulatory stability is becoming a competitive differentiator, and label durability cannot be assumed—particularly for advanced modalities. Companies are responding by building more flexibility into launch sequencing, evidence strategy, and risk mitigation planning earlier in development.

Further Reading

• UK Government — Pharmaceuticals deal announcement

• NHS Confederation — Changes to medicines policy explainer

• Morgan Lewis — UK–US trade deal analysis

• FDA — Elevidys revised indication and boxed warning press announcement

• Reuters — FDA adds strongest warning to Elevidys after fatal liver injuries

• PharmaTell Studio — U.S.–U.K. drug pricing and tariff agreement

• PharmaTell Studio — Potential for More Volatility after CDER leadership changes

• PharmaTell Studio — Sarepta Elevidys label update and safety strategy

Next-up in 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.