Rising evidentiary standards, pricing pressure and policy changes are redefining what it takes for pharmaceutical products to succeed. Pharmaceutical companies must rethink how R&D decisions are made, ensuring that clinical trial designs reflect the kind of evidence required for access and optimal reimbursement. Unfortunately, in too many companies, clinical development…
More than 22,000 pharmaceutical jobs were cut in 2025 as companies brace for a $300 billion patent cliff. But the real story is not workforce reduction. It’s the reshaping of competition, value and decision-making across the entire market. Pharmaceutical companies must move beyond cost-cutting and incremental innovation by embedding evidence,…
The departure of Dr. Vinay Prasad, a high-profile FDA regulator known for his strict adherence to traditional clinical trial standards, has renewed debate about how the agency should balance scientific rigor with timely patient access to emerging therapies. Rather than framing this moment as a binary choice between rigor and…
When Congress passed the Inflation Reduction Act in 2022, most headlines focused on lower drug prices for Medicare beneficiaries. Far less attention has been paid to how compressing the product prime earning cycle is reshaping pharmaceutical development and commercialization strategy. Pharmaceutical leaders need an alternative approach to the blockbuster model…
While both sides of the U.S. political aisle are focused on bringing down drug prices, they’re missing a critical lever for long-term change: raising the evidentiary bar for what qualifies as clinical value. In late 2025 the FDA signaled a major policy shift in removing barriers to the use of…
The FDA’s recent move to modernize evidence standards marks a turning point in how drug value will be judged, priced and compared globally, with direct consequences for how pharmaceutical companies operate internally. If evidence is becoming the currency of value, pharmaceutical leaders must stop treating it as a downstream exercise…
