Regulatory

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 . . .

The FDA has accepted for review Sunovion’s resubmission of the NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD, the company said. Sunovion received a complete response letter to the previously submitted NDA… Read more . . .

Acorda Therapeutics has submitted a 505(b)(2) new drug application for Inbrija (CVT-301) levodopa for the treatment of symptoms during OFF periods in Parkinson’s disease patients, the company said. According to the company, the FDA is… Read more . . .

Boehringer Ingelheim has filed a citizen petition with the FDA asking the agency to “request the Commissioner of Food and Drugs to ensure that any New Drug Application (“NDA”) for a fixed-dose, triple-combination, inhaled drug… Read more . . .

Medical Developments International (MVP) has announced that Health Canada has accepted its submission for the Penthrox methoxyflurane inhaler, triggering a $250,000 Canadian milestone payment to MVP from Purdue Pharma Canada. In September 2016, MVP announced… Read more . . .