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The Senate and House Appropriations Committees are calling on the FDA to issue guidance on biosimilars standards and work with industry to prevent drug shortages as part of their fiscal 2016 funding bills. Read More
UnitedHealth Group plans to use its market strength to negotiate prices to help consumers purchase expensive specialty drugs, adding to a growing press from doctors, patient advocates and lawmakers to rein in costs. Read More
The European Medicines Agency is recommending the first-ever malaria vaccine, GSK’s Mosquirix, as a protection for children ages six weeks to 17 months in sub-Saharan Africa. Read More
The FDA Friday gave the green light to Sanofi and Regeneron’s cholesterol-lowering drug Praluent, beating Amgen’s Repatha in a race to be the first PCSK9 inhibitor in the U.S. Read More
Drugmakers making changes to analytical validation methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says. Read More
Drug compounding groups are urging the FDA to revise a draft memorandum of understanding that outlines how states should regulate small compounders, saying a proposed cap on interstate shipments of compounded products would hinder patient access and unduly burden state enforcement agencies. Read More
Indian generics maker Lupin is set to buy privately held U.S. generics maker Gavis Pharmaceuticals for $880 million, a move that expands Lupin’s share of the U.S. generics market. Read More
The European Medicines Agency has recommended approval of Shire’s Intuniv to treat attention deficit hyperactivity disorder — potentially breathing new life into the drug, which is facing new competition from generics in the U.S. Read More
The European Medicines Agency is declaring that six classes of diseases occur in children, forcing drugmakers to conduct pediatric tests prior to approval. Read More