NICE have now published final draft guidance approving GlaxoSmithKline’s gene therapy Strimvelis for an ultra-rare immune deficiency condition commonly referred to as bubble baby syndrome.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,
GSK’s biologic Nucala is the first therapy specifically approved in the US to treat a rare disease called eosinophilic granulomatosis with polyangiitis (EPGA). EGPA is an autoimmune disease that causes vasculitis, which is an inflammation in the wall of blood vessels of the body. The disease is characterised by asthma, high levels of eosinophils, and
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
GlaxoSmithKline and collaborator, Johnson & Johnson, have filed for approval of RA drug sirukumab in the EU. If the drug gains approval it will compete with Roche’s Actemra, which is currently worth $1.5bn. GSK and J&J’s Janssen Biologics unit are seeking EMA approval for their drug in combination with methotrexate in patients who have failed
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).
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
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
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
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.
GlaxoSmithKline (GSK) has become the first big pharma company to support the AllTrials campaign, which intends to improve clinical trial transparency. The campaign, which is supported by Dr Ben Goldacre, Bad Pharma’s author, and Dr Fiona Godlee, BMJ editor, is pushing for registration of clinical trials and the disclosure of results and reports to help
