Regulatory

According to Vectura, the FDA has approved the company’s investigational new drug (IND) application for VR647 nebulized budesonide, which the company is developing for the treatment of asthma in children aged 12 months to 8… Read more . . .

According to Pulmatrix, its PUR1900 itraconazole DPI for the treatment of pulmonary aspergillus infections in cystic fibrosis patients has received Qualified Infectious Disease Product (QIDP) designation from the FDA. Pulmatrix CEO Robert Clarke commented, “The… Read more . . .

Neurelis has announced that its NRL-1 intranasal diazepam has received Fast Track designation from the FDA for the treatment of acute repetitive or cluster seizures in epilepsy patients. The company plans to submit an NDA… Read more . . .

Amphastar Pharmaceuticals subsidiary Armstrong Pharmaceuticals has received a complete response letter from the FDA in regard to its NDA for the Primatene Mist epinephrine inhaler, Amphastar has announced. The CRL said that the FDA would… Read more . . .

According to Cipla, its Sereflo fluticasone/salmeterol MDI, a generic version of Advair (Seretide), has been approved by the UK MHRA for the treatment of asthma, and the product will be launched by a partner in… Read more . . .

Easyhaler maker Orion Corporation has announced that it plans to submit a marketing authorization application in the EU for its salmeterol/fluticasone DPI for the treatment of asthma and COPD in the first half of 2017.… Read more . . .

In advertisements appearing in British nursing, pharmaceutical, and medical journals.the Prescription Medicines Code of Practice Authority (PMCPA), the administrator of the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry,… Read more . . .

Evoke Pharma says that it recently had a positive pre-NDA meeting with the FDA regarding clinical data to be included in its planned 505(b)(2) NDA for Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis… Read more . . .

GlaxoSmithKline and Innoviva have announced that GSK has filed an MAA with the European Medicines Agency for its fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD. In November 2016, GSK submitted an NDA for the… Read more . . .

GlaxoSmithKline and Innoviva have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the 100/25 mcg strength of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD. Both the… Read more . . .