Development challenges and regulatory changes for cell and gene therapies

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Cell and gene therapies are the fastest growing area for drug development. The groundwork for this category was laid with the mapping of the human genome in 2003, and the field has developed rapidly in the intervening decades. These powerful therapies have significant potential for the treatment of cancer and other previously “undruggable” diseases. But cell and gene therapies also have unique characteristics that can lead to manufacturing challenges and extended regulatory timelines. As of February 2020, cell and gene therapies account for 12% of the preclinical pipeline and 16% of the clinical pipeline.

Given the scale of investments made to support these development efforts and advancements possible, drug sponsors have looked to the U.S. FDA to consider accelerating gene and cell therapy development. The regulatory body has responded by shifting its departmental structure to st…

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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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