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The EMA authorized fewer new active substances and orphan drugs in 2019 than in the previous year, according to the agency’s highlights released yesterday. Read More
Hospira prevailed this week in a Florida lawsuit that alleged the Pfizer subsidiary falsely advertised its epinephrine products as being FDA approved. Read More
In an unusual move, Celgene has backed out of a $55 million settlement to clear accusations of anticompetitive behavior over its cancer treatments Revlimid and Thalomid, attorneys for the plaintiffs announced Wednesday. Read More
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