NICE publish final draft guidelines for GSK’s gene therapy, Strimvelis

NICE have now published final draft guidance approving GlaxoSmithKline’s gene therapy Strimvelis for an ultra-rare immune deficiency condition commonly referred to as bubble baby syndrome. Severe combined immunodeficiency due to adenosine deaminase deficiency, (ADA-SCID) is an inherited genetic condition affecting the body’s white blood cells, that renders the body’s immune system unable to function properly,

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GSK submits application in EU to extend use of Relvar Ellipta for use in asthma

GlaxoSmithKline and Innoviva have applied in Europe to market Relvar Ellipta for extended use in patients with asthma who are already adequately controlled on inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy. The treatment, comprised of the ICS fluticasone furoate (FF) and the LABA vilanterol (VI), is currently indicated in Europe for the regular treatment of patients

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Scotland Approves Novartis / ThromboGenics’ Jetrea and Roche’s RoActemra

The Scottish Medicines Consortium (SMC) has announced their latest set of recommendations approving regulatory submissions for Novartis and ThromboGenics’ eye therapy Jetrea and Roche’s RoActemra. The SMC have also announced rejections for the chronic obstructive pulmonary disease (COPD) drugs submitted for approval by Boehringer Ingelheim and GlaxoSmithKline (GSK).

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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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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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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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