1. A final rule that would have revised the FDA’s definition of intended use and potentially restricted off-label use of prescription drugs was delayed until March 2018. It was expected to go into effect on March 21. In a notice published March 17 in the Federal Register, the agency wrote that it is delaying the effective date to invite public comments on issues raised by a citizen petition from industry groups. (Notice)
2. Amgen’s cholesterol drug Repatha reduced the risk of heart attack, stroke, and cardiovascular-related death by 20%. The study is the first to show that a PCSK9 inhibitor can do more than lower LDL cholesterol. (Kaiser Health News)
3. The FDA did not approve AstraZeneca’s ZS-9, a drug that treats hyperkalemia, a condition in which patients have high potassium levels in their blood, after a manufacturing inspection. It is the agency’s second time to reject ZS-9 after a manufacturing inspection, the first in 2015. (PMLive)
4. The U.K.’s healthcare cost watchdog, the National Institute for Health and Care Excellence, changed its drug approval process, to allow patients to have access to the most cost-effective drugs about five months earlier than the current process. The drug industry and health charities argued that the new system would delay drug access. (OnMedica)
5. The FDA’s Center for Tobacco Products launched stop-motion PSAs featuring a shriveled pair of smokers’ lungs living in misery. FCB New York developed the ads, which target teenage smokers. (Adweek)
