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The FDA slapped Blue Ridge Pharmacy and Compounding Center with a warning letter for compounding products without a prescription and poor conditions for aseptic processing, another sign that the agency doesn’t plan to let up on large compounders. Read More
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official said. Read More
Takeda scored a legal victory last week when an Illinois jury found the drugmaker wasn’t responsible for a man’s death while he was on the diabetes drug Actos. Read More
Injectable drug maker Hospira has issued a voluntary recall of dobutamine injection, USP, after a customer complaint of discoloration in a single vial of the heart disease drug. Read More
The FDA has rejected Novartis’ heart drug Reasanz due to minimal data on efficacy, the latest regulatory setback for the experimental treatment. Read More
The FDA blasted generic drugmaker Alvogen for a promotion of the alcoholism treatment disulfiram that omitted potentially life-threatening risks. Read More
Abbott Labs is poised to double its presence in generic pharmaceuticals in Latin America with a planned purchase of Chile-based generics manufacturer CFR Pharmaceuticals, the companies announced Friday. Read More