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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
Par Pharmaceuticals has sued the FDA for not granting the company 180 days of marketing exclusivity for its first generic of Takeda Pharmaceutical’s Colcrys, asking a federal court to enjoin the agency from approving any competing generics. Read More