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 rights to the product; Almirall retains the rights elsewhere. The aclidinium bromide formulation is delivered via a multi-dose DPI and will … [Read more...] about Forest and Almirall submit NDA for aclidinium bromide
Regulatory
Another negative opinion from CHMP on Bronchitol
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 that it would vote against the authorization. Pharmaxis chose not to withdraw the marketing authorization … [Read more...] about Another negative opinion from CHMP on Bronchitol
Lamellar gets orphan designation for inhaled CF drug
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 that can serve as lubricants and surfactants. The company says that it has data showing that LMS-611 has "significant … [Read more...] about Lamellar gets orphan designation for inhaled CF drug
SPARC announces plans to launch new DPI
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 end of the 2nd quarter of the fiscal year. In addition, the company said, it plans to file an IND in the US by the end of the fiscal year. The DPI delivers a dry powder … [Read more...] about SPARC announces plans to launch new DPI
Aradigm ciprofloxacin for bronchiectasis gets orphan drug designation
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 the FDA for the treatment of bronchiectasis and for cystic fibrosis. The dual release formulation combines … [Read more...] about Aradigm ciprofloxacin for bronchiectasis gets orphan drug designation
Elpen’s Advair copy approved by Sweden
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 not said when or if it will launch the product in European countries outside of Greece. Elpen has been marketing the inhaler … [Read more...] about Elpen’s Advair copy approved by Sweden
FDA accepts NDA for Nycomed nasal aerosol
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 device for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years old and older. Sunovion (formerly Sepracor) owns the … [Read more...] about FDA accepts NDA for Nycomed nasal aerosol
MAP Pharmaceuticals submits NDA for Levadex
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 breath-activated MDI, the Tempo inhaler. MAP recently published data from its Phase 3 FREEDOM-301 trial, in which Levadex met all 4 primary … [Read more...] about MAP Pharmaceuticals submits NDA for Levadex
CHMP issues negative opinion on Pharmaxis’s Bronchitol
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 the trend vote after hearing an oral presentation by Pharmaxis regarding the application at its meeting last week. The official vote to … [Read more...] about CHMP issues negative opinion on Pharmaxis’s Bronchitol
MannKind reveals details of latest FDA review meeting
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, Alfred Mann characterized the meeting as "positive and collaborative, resulting in a redirection of the Type 2 trial that should enable us to support use of … [Read more...] about MannKind reveals details of latest FDA review meeting