EMA and FDA Create Pharmacovigilance Collaboration

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have announced that they will reinforce their efforts on medicines safety through regular collaborative meetings. The regulatory agencies confirmed that they will be forming a new pharmacovigilance ‘cluster’ to provide an opportunity to share information on the safety of medicines. The cluster

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NICE Draft Guidance Recommends Astellas’ Xtandi for Prostate Cancer

Regulatory body, the National Institute for Health and Care Excellence (NICE), have opened a second consultation on the use of Astellas’ Xtandi in patients with prostate cancer, after widening the drug’s target population. The regulatory affairs agency issued new draft guidance this morning recommending the use of Xtandi in adult patients with hormone relapsed metastatic

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GlaxoSmithKline’s Tafinlar Receives FDA ‘Breakthrough’ Status

GlaxoSmithKline’s (GSK) Tafinlar (dabrafenib) was yesterday granted ‘breakthrough’ status by the US Food and Drug Administration (FDA), meaning it will be fast tracked through the US regulatory system. The US regulatory body granted authorisation to accelerate Tafinlar’s development as a drug for metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC), in patients who have

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