Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy. So grab that cup of stimulation and get started. Our flavor today is crème brulée, for those tracking our habits. Now, though, the time has come to get busy. So please grab your own cup and dig in to the items of interest assembled below. We hope you have a wonderful day, and please do keep in touch. …
Novo Nordisk has asked the U.S. Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make, STAT reports. Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. But Novo argued that semaglutide, marketed as Ozempic for diabetes and Wegovy for obesity, should be on the FDA’s “Demonstrable Difficulties for Compounding Lists,” which are lists of complex medications that compounders are not allowed to make regardless of shortages, according to documents the agency posted this week. The FDA still has to make a decision on whether to officially place semaglutide on the lists. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.
Amgen will launch its biosimilar version of a blockbuster Regeneron Pharmaceutical drug for an eye disease following a U.S. appeals court ruling in its favor, Reuters writes. The U.S. Court of Appeals for the Federal Circuit rejected Regeneron’s request to block the launch during its appeal of a related decision for Amgen in a patent case in West Virginia. Eylea can treat eye diseases like macular degeneration, macular edema, and retinopathy, and was first approved by U.S. regulators in 2011. Last year, the drug generated $5.89 billion in U.S. sales. Regeneron sued Amgen for infringing dozens of its patents related to Eylea, but a West Virginia federal judge last month rejected a bid by Regeneron to block Amgen’s launch of Pavblu while it pursues its patent claims in the ongoing case. With its decision, Amgen is pursuing what is known as an ‘at-risk’ launch, because if the company loses the patent cases to Regeneron, it could face steep damages.
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