European Medicines Agency Approves GSK / Theravance’s Relvar

GlaxoSmithKline (GSK) and Theravance’s inhaled lung drug, Relvar, has been approved by Europe’s regulatory body to treat both asthma and chronic obstructive pulmonary disease (COPD). Relvar is a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist (LABA) vilanterol, and is delivered through the Ellipta inhaler.  The drug has already been approved

Continue Reading

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

Continue Reading

GlaxoSmithKline’s Tafinlar Receives EU Approval

GlaxoSmithKline’s (GSK) Tafinlar has been given the green light by the European Commission to be used as an oral treatment for unresectable or metastatic melanoma in adults with a BRAF V600 mutation. Tafinlar (dabrafenib) is an orally bioavailable inhibitor of BRAF,  part of the pathway that regulates the normal growth and death of cells.  Mutations

Continue Reading

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.

Continue Reading