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GSK launches late-stage study of long-acting antibody for severe asthma pharmatimes
March 18, 2021
GlaxoSmithKline (GSK) has dosed the first patient in a Phase III trial investigating its long-acting anti-IL-5 monoclonal antibody for the treatment of severe eosinophilic asthma (SEA).
FDA Accepts Dupixent for Review in Children with Moderate-to-severe Asthma americanpharmaceuticalreview
March 09, 2021
Regeneron Pharmaceuticals and Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent? (dupilumab) as an add-on treatment for children aged 6 to 11 years ...
FDA to review Sanofi’s Dupixent in children with uncontrolled asthma pharmatimes
March 05, 2021
The US Food and Drug Administration (FDA) will review Sanofi’s Dupixent as an add-on treatment for children aged six to 11 years with uncontrolled moderate-to-severe asthma.
Tezepelumab significantly reduces exacerbations of severe asthma europeanpharmaceuticalreview
March 02, 2021
In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
CHMP opinions: EMA refuses asthma label expansion for GSK’s COPD drug Trelegy Ellipta pharmaceutical-technology
March 02, 2021
The European Union’s healthcare regulator the European Medicines Agency (EMA) has decided against a label expansion for GlaxoSmithKline (GSK)’s drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include asthma.
Overuse of reliever medication for asthma a ‘major contributor’ to greenhouse gas emissions pharmatimes
February 19, 2021
New data has found that the overuse of short-acting beta2-agonist (SABA) relievers for asthma in the UK is responsible for 250,000 tones of greenhouse gas emissions – or CO2 – annually.
NICE green light for GSK's Nucala pharmatimes
February 05, 2021
GlaxoSmithKline's Nucala (mepolizumab) will be funded on the NHS in England and Wales for treating patients with severe eosinophilic asthma.
EU approves Chiesi’s triple combination asthma therapy Trimbow pharmatimes
February 02, 2021
The European Commission (EC) has approved a marketing authorisation for Chiesi Group’s triple combination asthma therapy Trimbow (beclometasone/formoterol/glycopyrronium).
Chiesi Group Receives EMA for Triple-Combination Therapy Asthma americanpharmaceuticalreview
February 02, 2021
Chiesi announced the European Commission has granted the marketing authorization for Chiesi extrafine triple therapy combination ICS/LABA/LAMA in a single inhaler, for the treatment of asthma.
AstraZeneca secures China approval for treating mild asthma with Symbicort Turbuhaler pharmaceutical-business-review
January 29, 2021
AstraZeneca announced that it has secured regulatory approval from China’s National Medical Products Administration (NMPA) for Symbicort Turbuhaler, an anti-inflammatory reliever to relieve symptoms of mild asthma.