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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
In a confidential deal with the drugmaker, the pricing in Ontario depends on how many patients seek treatment and the number of doses needed. Read More
Chinese generics and biosimilars should be allowed to flow into the U.S. without punitive tariffs, the generics makers’ largest trade association has said. Read More
Opioid sponsors would have to prove that their drug candidates are better than currently approved drugs under new guidelines that the FDA is considering, the agency announced Thursday. Read More