Pharmalittle: German regulator eyes Ozempic export ban amid shortages; NIH-funded clinical trials lagging pharma’s in enrollment

Good morning, everyone, and how are you today? We are doing just fine, thank you. Given that this is already the middle of the week and we have survived this far, no reason not to continue, yes? Just consider the alternatives. In fact, this modest accomplishment calls for celebration. So please join us in quaffing a ritual cup of needed stimulation. Our choice today is chocolate cappuccino. Or grab a bottle of water, if you prefer. Meanwhile, here are a few items of interest to help you along. Once again, we hope you have a successful day and, of course, keep in touch. We enjoy hearing your tips and tidbits. …

The German drug regulator is considering an export ban on Novo Nordisk’s diabetes drug Ozempic, which is in high demand for weight-loss, as European health systems grapple to stem a supply shortage, Reuters writes. Ozempic is approved to treat type 2 diabetes when more established therapies have failed, but has increasingly been prescribed “off-label” to treat weight loss because it has the same active ingredient as Novo’s anti-obesity drug Wegovy. Novo’s launch of Wegovy, a high-dose version of Ozempic, in the U.K., Germany, Norway, and Denmark, has so far failed to temper a craze for Ozempic as volumes of Wegovy have been limited due to production bottlenecks.

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The new U.S. National Institutes of Health director, Monica Bertagnolli, said it is a “failure” that enrollment in government-funded clinical trials has lagged behind those funded by the pharmaceutical industry, STAT says. Bertagnolli also hedged and said that the pharmaceutical industry has produced “amazing results,” but that there is an important role for NIH in answering questions that are “not of central interest to pharma. … If you just look at the number of patients who go on government-funded trials, it’s been completely flat over the last decade,” she said at a meeting of the advocacy group Friends of Cancer Research.

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