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A federal judge has ruled that the government incorrectly threatened AstraZeneca with fines for limiting discounts to the controversial 340B Drug Discount program for safety-net hospitals. Read More
The Senate is expected to vote today to end discussion on a continuing resolution that would keep the federal government funded at fiscal 2021 levels beyond Feb. 18. Read More
EMA follows FDA, which in December added its strictest warnings to the labels of a handful of JAK inhibitors, citing risk of serious health issues and death. Read More
HSS recently appealed court rulings that said the agency shouldn’t have slapped the drugmakers with fines for refusing to participate in the program. Read More
Six Republican senators including Mike Lee (Utah), Ted Cruz (Tex.) and Rand Paul (Ky.) circulated a “Dear Colleague” letter on Tuesday to other lawmakers, signaling their intention to delay voting on the continuing resolution to fund the government beyond Feb. 18 unless it includes an amendment to defund federal COVID-19 vaccine mandates. Read More
The Institute for Clinical and Economic Review (ICER) has weighed in on Eli Lilly’s type 2 diabetes drug candidate tirzepatide, saying payers should consider broadening coverage to GLP-1 RAs and SGLT-2 inhibitors like tirzepatide for diabetes type 2 patients with cardiovascular or renal disease — but only at a cost of $5,500 to $5,700 per year. Read More
Robert Califf has, at long last, been confirmed as the new commissioner of the FDA, in a close 50-to-46 Senate vote that contrasted with his easy 89-to-4 confirmation vote to the leadership role in 2016. Read More