Roche delays European filing of breast-cancer pill giredestrant amid US pricing pressures
read at Endpoints ↗RegulatoryNeutral
Roche announced it will now seek European approval for its investigational breast cancer oral therapy giredestrant later than previously planned.
The delay reflects the impact of U.S. drug pricing pressures, including most-favored-nation clauses, on the company's launch strategy for Europe.
Analysts note that such pricing dynamics could reshape timing of new drug introductions across the continent, as firms adjust to regulatory and market conditions.
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This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “Roche’s changing plans show how MFN is complicating European drug launches”
read at Endpoints ↗95 words · retrieved 18m ago
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