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Janssen’s Spravato (esketamine) spray—approved by the FDA in March for treatment-resistant depression —isn’t cost-effective at its listed price, a nonprofit drug price watchdog says. Read More
President Trump on Monday signed what he termed a “breakthrough” executive order requiring hospitals to inform patients of the prices they hash out with insurers. Read More
The defendants are accused of using cryptocurrency on the so-called dark web to import synthetic opioids and make pills on industrial-grade machinery. Read More
Aclaris made misleading claims in a TV ad for its seborrheic keratosis treatment Eskata and failed to include details of potential side effects, CDER’s Office of Prescription Drug Promotion said in an untitled letter to the firm. Read More
The New Jersey legislature has approved a sweeping new bill that bans gag clauses in contracts between PBMs and pharmacies as well as so-called copay clawbacks. Read More
Sponsors who submit drugs or biologics through the FDA’s accelerated programs will have to submit all their promotional materials in advance electronically beginning in 2021, the agency says in final guidance issued Friday. Read More