Three strikes in pharma: Exploring recent drug withdrawals and clinical trial challenges

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Pharmaceutical companies face a long list of regulatory challenges ranging from patent expiry to bioequivalence and international harmonization. It’s not uncommon for drug makers to withdraw or discontinue drugs after failing to meet clinical requirements or endpoints, resulting in drug withdrawals. On average, life science companies pull roughly 4,500 drugs and devices from the market, many of which are widely used. In recent years, drug companies, for instance, have pulled a growing number of products for nitrosamine contamination. While the FDA can identify safety concerns, it often falls upon the manufacturer to initiate and execute a recall.

Here, we round up three recent examples of recent drug withdrawals where pharma companies either pulled drugs from the market or gave up on developing a drug for a given indication.

Covis Pharma withdraws Makena

The Zug, Switzerland–base…

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