Regulatory
-
Forest Laboratories and Almirall have submitted a new drug application to the FDA for their inhaled aclidinium bromide, a dry powder long-acting inhaled antimuscarinic agent for the treatment of COPD. Forest has licensed the US… Read more . . .
-
The Committee for Medicinal Products for Human Use (CHMP) has recommended against granting a marketing authorization to Pharmaxis’s Bronchitol inhaled dry powder mannitol formulation for the treatment of cystic fibrosis. The CHMP had previously indicated… Read more . . .
-
Lamellar Biomedical’s LMS-611, an inhaled Lamellasome, an artificial lamellar body, for the treatment of patients with cystic fibrosis has received orphan drug designation from the European Commission. CF patients’ lungs may be missing lamellar bodies… Read more . . .
-
Sun Pharma Advanced Research Company (SPARC) has announced completion of Phase 3 studies for a new dry powder inhaler and its intention to launch a product based on the novel DPI in India by the… Read more . . .
-
The US FDA has granted orphan drug designation to Aradigm Corporation’s dual release ciprofloxacin for inhalation (DRCFI) for the treatment of bronchiectasis. The company’s liposomal ciprofloxacin for inhalation (CFI) already has orphan drug designation from… Read more . . .
-
Reuters is reporting that the Swedish Medical Products Agency has approved a fluticasone/salmeterol DPI manufactured by Greek pharmaceutical company Elpen. The approval apparently took place in May 2011 but was not announced. The company has… Read more . . .
-
The US FDA has accepted the filing of the new drug application for its ciclesonide nasal aerosol, according to Nycomed and Sunovion. The product is an HFA formulation of ciclesonide delivered by a metered dose… Read more . . .
-
MAP Pharmaceuticals has submitted a new drug application (NDA) to the US FDA for its Levadex inhaled dihydroergotamine (DHE) for the treatment of migraines. The delivery device used for the product is the company’s proprietary… Read more . . .
-
Members of the Committee for Medicinal Products for Human Use (CHMP) have indicated that they would vote against approval of Pharmaxis’s marketing application for Bronchitol as a treatment for cystic fibrosis (CF). The CHMP took… Read more . . .
-
Five days after its end of review meeting with the FDA on May 4 regarding its Afrezza inhaled insulin, MannKind Corporation held a conference call to update its progress and financial situation. During the call,… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland