The FDA has approved Novartis's Arcapta Neohaler with a 75 mcg once-daily dose of indacaterol for the treatment of COPD. Novartis sells an indacaterol inhaler in Europe as the Onbrez Breezhaler. The company plans to launch the Arcapta Neohaler in the US in the first quarter of 2012. An FDA advisory committee recommended approval of the 75 mcg dose in March 2011 … [Read more...] about FDA approves indacaterol
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FDA approval for fentanyl nasal spray
The FDA has approved Archimedes Pharma's Lazanda fentanyl nasal spray for the treatment of breakthrough pain in cancer patients 18 years old and older. The product is already marketed in five European countries, where it is called PecFent. “Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain," said Jeffrey … [Read more...] about FDA approval for fentanyl nasal spray
Forest and Almirall submit NDA for aclidinium bromide
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
Phase 3 study shows NVA237 as effective as tiotropium
NVA237, a glycopyrronium bromide dry powder formulation licensed by Novartis from Sosei and Vectura has met its primary endpoint in the Phase 3 GLOW2 trial. According to Sosei, the study showed that NVA237 had similar efficacy to tiotropium and provided significant improvement in lung function when given once a day to COPD patients with moderate-to-severe … [Read more...] about Phase 3 study shows NVA237 as effective as tiotropium
Prosonix obtains additional financing
Particle engineering company Prosonix has secured £11.4M from a group of investors led by French venture company Ventech. Other investors involved in this round of financing include Entrepreneurs Fund, Quest for Growth, and Solon Ventures, all of which are already invested in Prosonix, plus new investor Gilde Healthcare Partners. The company plans to use the money … [Read more...] about Prosonix obtains additional financing
Pulmatrix announces new appointments
Pulmatrix, which recently launched its new iSperse dry powder delivery system, has announced the promotion of Robert Clarke to Chief Scientific Officer (CSO) and VP of Research and Development. In addition, the company has added 8 members to its scientific advisory board. Clarke has been leading research efforts at Pulmatrix since 2004 after leaving Alkermes. … [Read more...] about Pulmatrix announces new appointments
Study finds cellulose nasal powder effective for allergic rhinitis
Researchers from the University of Goteborg, Sweden, have found that an intranasal cellulose powder significantly reduced allergic rhinitis symptoms in children. The double-blind study involved 53 children with allergies to birch pollen. Nils Åberg, associate professor at the Department of Pediatrics and consultant at the Queen Silvia Children's Hospital … [Read more...] about Study finds cellulose nasal powder effective for allergic rhinitis
Gerresheimer doubling size of inhaler manufacturing facility
Gerresheimer will spend €12m to add approximately 5,000 sq. meters to the plastics production area at its manufacturing facility in Horsovsky Tyn, Czech Republic. The plant produces medical plastic devices, including insulin pens and inhalers. According to the company, an increase in demand for the products is leading it to double the size of the … [Read more...] about Gerresheimer doubling size of inhaler manufacturing facility
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
Pfizer reportedly retaining R&D at Sandwich site
According to news reports, Pfizer has reversed its position on the closure of its R&D facility at Sandwich, UK, saving 350 jobs. The company's inhalation R&D group has operated out of Sandwich and had been in limbo after the company announced in February that it would be closing the site. Annette Doherty, the new site director at Sandwich, commented: "Pfizer's … [Read more...] about Pfizer reportedly retaining R&D at Sandwich site