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A federal judge refused to dismiss a false advertising lawsuit filed by Allergan against drug compounder Imprimis Pharmaceuticals concerning its dry-eye drug Klarity, meant to compete with Allergan’s Restasis. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
Medicare Part D beneficiaries could shop for drugs at more pharmacies and take advantage of cheaper new generics sooner under revised rules proposed by the Centers for Medicare and Medicaid Services. Read More
An FDA advisory committee voted Thursday to not recommend two regimens for Bayer’s inhalation-powder formulation of ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis, citing inconsistent data from clinical trials. Read More
The Senate gave final congressional approval to a bill designed to resolve a dispute involving FDA and the Department of Defense, preserving FDA’s authority over authorizing innovative medical treatments for soldiers while streamlining the process for granting the authorization. Read More
A sweeping tax overhaul bill approved by the House in a 227-205 vote Thursday would eliminate the orphan-drug tax credit, although the version of the legislation up for Senate consideration wouldn’t go that far. Read More