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CHMP recommends label update for Esbriet in idiopathic pulmonary fibrosis, strengthening mortality benefit and reinforcing safety profile

27 October 2014 | By Roche

Roche announced that Esbriet® (pirfenidone) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for an update to its European prescribing information, strengthening the efficacy claims and supporting the well-established safety profile based on the additional data from the phase III ASCEND trial...

Europe approves novel Australian drug developed for rare sun disease

27 October 2014 | By Clinuvel Pharmaceuticals Limited

The first new pharmaceutical drug invented and developed for an untreated disorder by any Australian company has received regulatory approval from the European Medicines Agency (EMA). SCENESSE® (afamelanotide 16mg) treats the debilitating genetic disorder porphyria (EPP), or absolute intolerance to sunlight...