GlaxoSmithKline’s Trametinib Granted Quick Review by EMA

The European Medicines Agency (EMA) has granted GlaxoSmithKline’s (GSK) melanoma drug an accelerated review. The melanoma drug, a MEK inhibitor named trametinib, is requesting a European licence as both a monotherapy and in combination with their investigational BRAF inhibitor dabrafenib, for the medication of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

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Ridaforolimus EMA Submission Pulled by Merck

Merck have suffered a hindrance this week with the withdrawal of their Marketing Authorization Application for ridaforolimus in Europe. The European Medicines Agency (EMA) was evaluating ridaforolimus as a possible maintenance treatment for patients with soft tissue sarcoma or primary malignant bone tumour.  Merck have licensed the drug, an M-TOR inhibitor from Ariad Pharmaceuticals.

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Boehringer Submits Afatinib to EMA

Boehringer Ingelheim announced earlier today that they have submitted their first oncology compound, afatinib, to European regulators. The German firm filed a marketing authorisation application to the European Medicines Agency (EMA) for the approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC).  Boehringer confirmed that afatinib

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