-
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.