Drug development is hard and expensive, but so is commercialization. Biotechs that persevere and make it through late-stage pivotal trials face the challenges of gaining regulatory approval. Many biotech companies will never endure this because promising drug candidates often get licensed by more established commercial players with experience bringing new drugs to market.
Preparing to launch a new drug can be quite expensive, particularly for large, fragmented patient populations. We will explore one company that recently had its first regulatory submission accepted for review and another that plans to refile its application by the end of the year.
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