In a Phase III study, the biologic Dupixent met primary and all key secondary endpoints in children ages 6 to 11 who have uncontrolled moderate-to-severe asthma.
AstraZeneca Plc said the company’s asthma treatment Fasenra for a chronic inflammatory disease of the nasal passage linings, or sinuses, met main goals in a late-stage study.
The U.S. Food and Drug Administration approved a new indication for GlaxoSmithKline plc and Innoviva Inc.’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to the product’s current license for use in patients with chronic obstructive pulmonary disease (COPD).
Sanofi and Regeneron said results from a Phase III open-label extension trial showed that the safety and efficacy profile observed in previous Dupixent trials were maintained for up to three years in adults and adolescents with moderate-to-severe asthma.
A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
Swiss pharma giant Novartis is writing off the company’s program to develop a generic copy of GlaxoSmithKline’s blockbuster inhaler Advair.
Switzerland’s Novartis announced that the company’s LUSTER-1 and LUSTER-2 Phase III trials of fevipiprant for asthma failed to meet their clinically relevant endpoints.
Sanofi is ending diabetes and cardiovascular (DCV) research efforts as part of a revamp to narrow the number of the company’s business units in the hope of bolstering growth and profit.
Paris-based Sanofi announced the inaugural opening of the company’s first new digital manufacturing facility for biologics production in Framingham, Massachusetts.
A British court ruled in favor of Vectura Group and the company’s partner Sandoz over the packaging of a generic version of an inhaler made by bigger rival GlaxoSmithKline.