1. A government watchdog issued a pair of reports criticizing the FDA. One report said the regulator doesn’t keep up with scientific advances. The other took issue with the FDA’s strategic plan, which is expected to address the speed of approvals of new drugs and medical devices. (Stat)
2. The FDA said it strengthened existing warnings about the risk of acute kidney injury in patients taking certain type 2 diabetes medications, including Johnson & Johnson’s Invokana and Invokamet and AstraZeneca’s Farxiga and Xigduo XR. (FDA)
3. The Medicare Payment Advisory Commission proposed changes to Medicare’s prescription drug program in order to address rising drug costs. However, MedPAC did not recommend that the government be given the authority to negotiate drug prices. (AP)
4. People with diabetes are living longer, better lives due to advances in care as well as innovative new therapies, according to a new study. (Reuters)
5. A hedge fund executive allegedly received tips on generic drug approvals through an FDA official. Visium Asset Management’s Sanjay Valvani reportedly received information from a consultant who “duped” a former colleague at the FDA. (Bloomberg)
