STAT+: Pharmalittle: Europe regulator raised safety signal on Novo drugs; U.S. seeks new trial over royalties on Gilead HIV prevention pills
The U.S. government has asked a federal judge to overturn a recent case in which a jury decided that Gilead Sciences did not infringe on patents held by the CDC…
Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will celebrate this notion by brewing still more cups of stimulation and invite you to join us. Our choice today is blueberry cobbler. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch …
Leaders of European pharmaceutical companies argued that a proposed overhaul of European Union policies could render the industry less competitive, the latest step in their opposition to legislation that could shorten exclusivity periods for selling drugs, STAT writes. A European Commission draft law is the first major revamp of pharmaceutical policy in two decades, and touches on issues including antimicrobial resistance, drug shortages, and environmental impacts, while encouraging more equitable access to medicines across Europe. But an industry group expects a 25% decline in R&D and a drop in Europe’s global share of clinical trials from 25% to 19% if the law is passed.
A thyroid cancer safety signal was raised by the European Medicines Agency last month over several Novo Nordisk drugs, including semaglutide, which is used in popular diabetes and obesity drugs Ozempic and Wegovy, Reuters notes. The regulator raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. A signal from the EMA does not mean that the medicine is the cause of any reported adverse events. The safety signal was raised in a May 8 statement for several drugs in the so-called GLP-1 class, including semaglutide, including those from Eli Lilly, AstraZeneca and Sanofi.
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