Pharmalittle: Novo faces patent challenge on Wegovy and Ozempic; Senate panel moves to address drug shortages

Rise and shine, another busy day is on the way. We can tell because the official mascots got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy clamor of drills and saws and the like up and down the street. As for us, we are firing up the trusty coffee kettle to brew another cup of stimulation. Our choice today is Jack Daniels. Yes, this is a real thing. So please feel free to join us. Meanwhile, the time has come to get cracking. So here is the latest laundry list of interesting items for you to peruse. We hope you have a smashing day and, of course, do keep in touch. Best of luck, everyone. …

One of the top health care committees in the Senate is assembling ideas for bipartisan legislation to address drug shortages, according to STAT. The talks, led by U.S. Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho), are in the early days, but they could move the debate over drug-shortage reforms into a new phase. The committee has jurisdiction over Medicare and Medicaid payment policies for hospitals. The panel is tentatively aiming to hold a hearing on the issue in November and has also started accepting input from outside stakeholders. If a package coalesces, it likely would not be introduced until next year.

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A U.S. Patent Office tribunal agreed to review the validity of a Novo Nordisk patent related to its blockbuster diabetes and weight-loss drugs Ozempic and Wegovy at the request of generic drug maker Mylan Pharmaceuticals, Reuters notes. The U.S. PTO’s Patent Trial and Appeal Board said that Mylan had shown a reasonable likelihood that the Novo patent covering dosage regimes for the drugs was invalid. The decision comes two days after it rejected Mylan’s petitions to review two other Novo patents covering the active ingredient semaglutide in both drugs, dealing a setback to Mylan’s efforts to clear a legal path for generic versions.

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