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GSK's First Biologic Treatment For Asthma – Nucala Holds Multi-Billion Dollar Potential
Seeking Alpha Nucala was recently approved by the USFDA and EMA for the treatment of patients with severe Asthma of eosinophilic phenotype. In the base case, Nucala should reach peak sales of $2b. If Nucala is approved in other indications (COPD, HES) too, it can … |
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PMLiVE |
GSK's severe asthma therapy Nucala gets EU nod
PMLiVE GlaxoSmithKline's first-in-class interleukin-5 (IL-5) inhibitor Nucala has been approved in the EU as a steroid-sparing therapy for patients with severe asthma. Nucala (mepolizumab) has been cleared by the European Commission as an add-on treatment for … |
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GSK's Nucala gets FDA nod in asthma maintenance
BioWorld Online The FDA added another drug to the asthma armamentarium, with the approval of Glaxosmithkline plc's Nucala (mepolizumab) as a maintenance therapy for patients who have a history of severe asthma attacks despite being on treatment. Approval, disclosed … |
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PMLiVE |
CHMP backs GSK's asthma antibody and Novartis' heart failure drug
PMLiVE GlaxoSmithKline's mepolizumab for severe asthma and Novartis new' heart failure therapy Entresto have been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP). The panel issued positive opinions for the two drugs … |
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FDA panel backs approval of GSK's mepolizumab for severe asthma
ModernMedicine FDA's Pulmonary-Allergy Drugs Advisory Committee recently recommended approval of GlaxoSmithKline Plc's drug mepolizumab (Nucala) for severe asthma in patients aged 18 years and older. However, the panel voted 10 to 4 against approving the drug in … |
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ProPublica: Safety questions over GSK's Advair linger after years on the …
FiercePharma Recent research suggests that a significant percentage of asthma patients begin using Advair inappropriately, the watchdog says, and that can trigger the "risk of asthma-related death" described on the med's label. And while the FDA in 2010 required … |
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Lung Disease News |
FDA Rejects GSK's Breo Ellipta Asthma Therapy Use in Adolescents; Adult Use …
Lung Disease News GSK Incruse Ellipta COPD The U.S. Food and Drug Administration (FDA) ruled against the use of GlaxoSmithKline's new drug combination Breo Ellipta in asthma patients between the ages of 12 and 17. However, the Pulmonary-Allergy Drugs Advisory … |
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GSK's Breo for asthma? FDA panel says yes–but only in adults
FiercePharma Good news for GlaxoSmithKline ($GSK): An FDA panel of experts says the efficacy and safety data for blockbuster wannabe Breo support the asthma indication it's gunning for in adults 18 and older. When it comes to children aged 12 to 17, though? UPDATE 2-FDA panel backs Glaxo asthma drug for adults, not adolescents U.S. Panel Backs Glaxo's Breo for Asthma in Adults, Not Kids FDA panel backs Glaxo asthma drug for adults, not adolescents |
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Research and Markets: GSK's Flovent (Asthma) – Forecast and Market Analysis …
Business Wire (press release) Originally approved by the Food and Drug Administration (FDA) in 1996, GSK's Flovent (fluticasone propionate) is a synthetic ICS therapy with potent anti-inflammatory activity. It is used for the maintenance treatment of asthma prophylactically in … Research and Markets: GSK's Bosatria (Mepolizumab) Asthma Treatment … |
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Reuters India |
A respiratory expert undermines GSK's case for new asthma drug mepolizumab
FierceBiotech Investigators for GlaxoSmithKline ($GSK) detailed their promising Phase III data for the IL-5 biologic mepolizumab in asthma today, noting that the injectable halved the rate of exacerbations among a group of patients with uncontrolled cases of the … UPDATE 1-Cost a focus as GSK takes lead in new wave of biotech lung drugs |
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