The FDA isn’t afraid to yank a disappointing drug

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Good morning, everyone. Damian here with a look at some renewed interest in a yesteryear biotech craze, news of an FDA flex, and a dive into the science of vaccinology.

The need-to-know this morning

• Boehringer Ingelheim and Zealand Pharma said their experimental drug for obesity also succeeded in a mid-stage study involving participants with the fatty liver disease called MASH.
• Celldex Therapeutics and Sanofi presented new data from mid-stage studies of their respective treatments for chronic hives.
• Xolair, an asthma and allergy medicine marketed by the Genentech unit of Roche, reduced allergic reactions in children with food allergies, including peanuts.

The MASH goldrush is back on

For years, the prevalent fatty liver disease known as NASH was that rarest of pharmaceutical opportunities: a massive potential market without a single approved treatment. The industry’s interest seemed to subside after a metronomic series of clinical disappointments, but in 2024, the disease now called MASH is back in the spotlight thanks to a boom in obesity research.

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