FDA faces deadline for off-label marketing guidance; J&J puts media work up for review; AMAG sets up Makena adherence plan;

> The 21st Century Cures bill includes a provision directing the FDA to get on record with its latest off-label marketing policies, with a deadline likely in mid-2017. Report

> Johnson & Johnson ($JNJ) put its global media buying and planning work up for review for the first time since 2012. Report

> AMAG Pharmaceuticals ($AMAG) partnered with NurseWise, a triage and health education provider, on MyAdherence program, designed to keep patients on schedule with injections of its preterm labor preventive Makena. Release

> The British promotional watchdog, Prescription Medicines Code of Practice Authority, cited Otsuka and ViiV in its latest round of hand-slaps. Report

> The global market for treatments for high cholesterol and other blood lipid issues will grow to $38 billion by 2023, according to GlobalData, as new meds in the PCSK9 field hit the market. Release

> Sanofi's ($SNY) consumer unit Chattem launched a battery-operated device for back pain, IcyHot Smart Relief, using packaging with vivid colors on a black background and foil stamping. Report

> The British drugmaker BTG said its recent launch of Varithena, a varicose veins treatment, is slow now, but the drug is on track to build to $500 million in peak global sales. Report

And Finally... Bayer HealthCare announced a study showing that patients suffering a pulmonary embolism (PE) aren't properly monitored afterward for the possibility of pulmonary hypertension; the company sells a PE-fighter, Xarelto, and a pulmonary hypertension treatment, Adempas. Release