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Massachusetts court breaks new ground on brand-name liability in Merck appeal

Pharma - News – 16 March 2018

Massachusetts’ highest court has broken with precedent by finding that brand-name drug manufacturers owe a duty to users of generics to update the labels on their products if they become aware of risks of death or injury through the drugs’ use.


ECJ says courts, not agencies, can review drug exclusivity periods in marketing authorisation applications

Pharma - News – 14 March 2018

The European Court of Justice has ruled that regulatory agencies engaged in the EU’s decentralised procedure for generic drug marketing authorisation lack the authority to review the point when data exclusivity periods start to run on innovative drugs, finding instead that courts hearing challenges against generic market entry have the power to review such periods.






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