European Regulatory Approval for Eli Lilly / Boehringer’s Abasria

The European Commission has granted regulatory approval to Eli Lilly and Boehringer Ingelheim’s Abasria for treating diabetes in adults, adolescents and children aged two years and above. The approval follows EMA’s Committee for Medicinal Products for Human Use (CHMP) positive recommendation earlier this year. The previous recommendation noted that clinical studies of the insulin showed

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Merck & Co Submit Pembrolizumab to EU Regulators

Merck & Co yesterday announced that they have submitted pembrolizumab, to the European regulatory body, the European Medicines Agency. The company confirmed that the European Medicines Agency (EMA) has accepted the marketing authorisation application for review of Merck & Co’s investigational anti-PD-1 antibody for the treatment of advanced melanoma. The drug has demonstrated positive results

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European Regulators Grant Boehringer’s Nintedanib Accelarated Assessment

Boehringher Ingelheim have announced the successful marketing authorisation application for nintedanib, and confirmed that Europe’s regulatory body, the European Medicines Agency (EMA), will commence an accelerated assessment of the drug for the treatment of the fatal lung disease idiopathic pulmonary fibrosis (IPF). “IPF is a relentless and fatal lung disease, and there is a high

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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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Relvar Ellipta Supported by EMA Advisors

Advisors to the European Medicines Agency (EMA) have voted in support of approving GlaxoSmithKline/ Theravance’s Relvar Ellipta for both asthma and chronic obstructive pulmonary disease (COPD). The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a response recommending marketing authorisation for Relvar Ellipta, a combination of the inhaled corticosteroid fluticasone

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EMA Reports Steady Increase in Orphan Drug Designations

The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) have confirmed that they will incorporate the views of patients, increase international cooperation and collaborate with health technology assessment (HTA) bodies, with the aim of gaining a better understanding for orphan drug designation. The European Union (EU) orphan medicinal product regulation was started 12

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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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