Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have cool breezes and clear blue skies greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the coffee kettle for another cup of stimulation. Our choice today is French vanilla, an old standby. Please feel free to join us. Remember, no prescription is required. And now, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please do keep in touch. We have adjusted our settings to accept postcards and telegrams. …
The upheaval at the U.S. Food and Drug Administration appears to be taking a toll on the pharmaceutical industry, STAT writes, citing a new analysis of key agency metrics. There was a significant drop in drug approvals in the recently ended third quarter, more marketing applications were rejected than in previous months, and the agency delayed more reviews of those applications, the analysis by RBC Capital Markets found. To wit, the rate of drug approvals was 73%, which was down from an average of 87% in the six previous quarters. The analysts also found the rate of rejected marketing applications reached 15%, up from what they termed a “historical average” of 10%. And the delay rate in meeting deadlines for completing application reviews hit 11%, up from an average of 4%.
Novo Nordisk, which lobbied to win Medicaid reimbursement for its obesity drug Wegovy, is fighting to keep that coverage as some U.S. states struggle with the treatment’s costs, Reuters reports, citing state documents, company emails, and interviews with lawmakers and advocates. The lobbying efforts helped to convince 14 U.S. states to cover Wegovy for low-income patients under their Medicaid health insurance programs. The drugmaker argued that governments would save money on health care as more Americans lose weight and reduce their risk of diabetes, heart disease, and other conditions. Instead, several states found their spending surged due to Wegovy’s cost and widespread demand. California, North Carolina, Pennsylvania, and Connecticut have said they will cut weight loss drug coverage or seek to scale it back.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
Leave a Reply