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OTC drugmaker Emilia Resources drew a Form 483 from the FDA for failing to validate manufacturing processes and establish data controls, among other lapses at its facility in De Kalb, Mississippi. Read More
The Federal Circuit Court of Appeals gave Amgen another chance to prove that Amneal’s planned generic of its hyperparathyroidism treatment Sensipar (cinacalcet) infringes on its patent. Read More
Death rates for metastatic cancers have dropped by 5 to 6 percent annually for elderly patients the past three years, in part because of two “game-changing drugs” approved almost a decade ago by the FDA, according to the American Cancer Society (ACS). Read More
Allergan and Ironwood Pharmaceuticals reached a settlement with Sandoz to resolve patent litigation over Sandoz’s planned generic versions of their co-developed irritable bowel syndrome treatment Linzess. Read More