glp-1 drugs
Compounding pharmacies rebut Novo's FDA petition
Back in October, Novo Nordisk petitioned the FDA to bar compounding pharmacies from copying its weight loss drug semaglutide, citing safety concerns about the purity of these facsimiles. There have been ongoing shortages of GLP-1 drugs, and compounding pharmacies have stepped in to fill in supply gaps; to the chagrin of branded drugmakers, they have ended up with a pronounced market share of their own.
Now, in a lengthy letter, the Alliance for Pharmacy Compounding has now rebutted Novo's argument, saying that the company's assertion that compounded versions of the drugs are inferior is "unpersuasive." The letter says that Novo "disingenuously asserts" that compounded versions are unsafe and unreliable, highlighting patient satisfaction with the products — and says that these drugs have no place on the FDA's "Demonstrably Difficult to Compound" lists.
digital therapeutics
Orexo is divesting Deprexis, as it won't sell
Sweden-based drugmaker Orexo is giving up on Deprexis, its digital app meant to treat depression. The company's tried to sell it for years to no avail, and now will no longer license the product. Although it's been a struggle to secure reimbursement for digital therapeutics in the U.S., Orexo's timing is a bit surprising: Just a few weeks ago, Medicare created a pathway to help pay for some digital mental health treatment, STAT's Mario Aguilar writes.
"If you look at our balance sheet and our financial situation right now, you will understand that there is a need for us to focus," CEO Nikolaj Sørenson told STAT. Though the company was one plushly funded, its stock has dropped more than 80% since its peak in 2020. Most of Orexo's revenue comes from Zubsolv, a drug used to treat opioid addiction.
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