Regulatory

The European Commission has approved Chiesi’s Trimbow beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide MDI for the treatment of COPD in patients for whom an ICS/LABA combination is insufficient to control symptoms and prevent exacerbations, the company said.… Read more . . .

The FDA has approved 40μg and 80μg strengths of Teva’s QVAR RediHaler beclomethasone dipropionate breath-actuated MDI for treatment of asthma in patients aged 4 and older, the company said. Teva said that it expects to… Read more . . .

The FDA has designated the established name for Insmed’s inhaled amikacin, which is in Phase 3 development for the treatment of nontuberculous mycobacteria (NTM) lung infections, as “amikacin liposome inhalation suspension,” the company said in… Read more . . .

According to Indivior, the French regulatory agency Agence nationale de sécurité du médicament et des produits de santé (ANSM) has approved the company’s MAA for Nalscue naloxone hydrochloride nasal spray for the reversal of opioid… Read more . . .

Aradigm Corporation has filed a new drug application to for Linhaliq inhaled ciprofloxacin (formerly Pulmaquin) for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE), the company said. The company… Read more . . .

GSK has filed a supplementary NDA for approval of a 50mcg once-daily dose of the Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11. The FDA approved 100mcg and 200mcg… Read more . . .

Samumed’s SM04646 inhaled Wnt pathway inhibitor has been granted orphan drug designation by the FDA, the company has announced. The company recently announced positive Phase 1 results for SM04646, which it is developing for the… Read more . . .

GlaxoSmithKline and Innoviva have announced the filing of a submission to the EMA for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI (marketed as Breo Ellipta in the US) by patients whose asthma is… Read more . . .

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the reclassification of Nasonex mometasone furoate nasal spray from a “POM,” or “prescription only medicine,” to a “P” medicine, available over the counter at… Read more . . .

Functional respiratory imaging (FRI) specialist Fluidda has requested a Critical Path Innovation Meeting (CPIM) with the FDA as part of an initiative for approval of its FRI technology as a biomarker, the company said. According… Read more . . .