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Varied data requirements creating hurdles to pharma

While Regulatory authorities are concerned with assessing the safety, quality and efficacy of a product, the healthcare technology assessment (HTA) bodies monitor the product’s relative effectiveness and potential

EU to firm up action on counterfeit drugs

According to the Commission, increased penetration of the classical supply chain by the counterfeiters has led to a sharp rise of counterfeit drugs and seized fake medicines at

DiObex and Camurus sign license agreement

The development candidate is an extended release formulation of low dose glucagon for the prevention of insulin-induced hypoglycemia in patients with diabetes. Terms of the agreement include an

CSL’s Privigen meets study end points

The extension study was aimed to assess the tolerability and safety of Privigen, when administered at infusion rates higher than those of the pivotal study (12mg/kg/min, as opposed