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Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals. Read More
Sen. Charles Grassley (R-Iowa) is pressing Mylan and the Centers for Medicare and Medicaid Services for answers on the misclassification of the company’s EpiPen as a generic for the agency’s drug rebate program. Read More
The Pancreatic Cancer Action Network is planning an adaptive clinical trial that will use genomic profiling to assign individual patients different treatment options. Read More
The FDA has published 30 new product-specific recommendations on the design of bioequivalence studies for ANDAs, while also revising 30 of its previous recommendations. Read More
Adare Pharmaceuticals and Teva Pharmaceuticals International have sued Apotex, alleging its generic version of Amrix infringes on a patent covering the dosage forms of the drug’s active ingredient. Read More
In a Phase III trial, Janssen’s injectable plaque psoriasis treatment delivered better head-to-head clinical results than international top-selling drug Humira, which amassed over $14 billion in sales in 2015. Read More