The theory was that biotechs would become the innovation engine of Big Pharma, creating the products that drug companies would commercialize. Now, the trend has reversed itself. Drug companies are helping biotechs fill their pipelines, but with this twist--biotechs are then going out and selling those products to someone else at higher valuations.
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COVID-19 has helped demonstrate the viability of platform trials with a shared control arm. That model is easier to extol than it is for sponsors to embrace, especially outside of crisis mode.
With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.
US Institute for Clinical and Economic Review lays out options ranging from the status quo (unrestricted pricing) to compulsory licensing and advanced market commitments in a new white paper.