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The FDA has warned GlaxoSmithKline subsidiary SmithKline Beecham over its failure to adequately address contamination of drug ingredients manufactured at its Currabinny, Carrigaline, Cork, Ireland, plant. Read More
A federal court tentatively approved a $60 million payout by Hospira to end a class-action lawsuit that claimed the drugmaker misled investors about its quality problems. Read More
Novartis said Monday it has halted the Phase III trial of its chronic heart failure drug LCZ696 after being notified by a data monitoring committee that the drug met its composite primary endpoint of delayed cardiovascular death and reduced heart failure hospitalizations. Read More
Teva scored a legal victory Monday when the U.S. Supreme Court agreed to hear its appeal of a lower court ruling invalidating a patent for the drugmaker’s blockbuster multiple sclerosis drug Copaxone. Read More
The FDA has outlined the annual fees that large drug compounders that register as outsourcing facilities will have to pay the agency under new federal law. Read More
Japanese drugmaker Eisai’s U.S. subsidiary is selling and assigning its U.S., Canadian and Japanese development and marketing rights to Dacogen to Otsuka Pharmaceuticals. Read More
Massachusetts last week became the first state to ban Zogenix’s controversial painkiller Zohydro, a move that could lead other states to follow suit. Read More
The FDA Friday approved Janssen Pharmaceuticals’ Topamax for the prevention of migraines in adolescents, the first such drug for this age group. Read More