Pharmaxis's Bronchitol mannitol dry powder for inhalation has become the first treatment for cystic fibrosis to receive a positive recommendation from he UK National Institute for Health and Clinical Excellence (NICE), according to the company. The recommendation allows for reimbursement by the National Health Service. Pharmaxis CEO Alan Robertson commented, … [Read more...] about NICE approves Bronchitol inhalation powder for CF
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Novartis files MAA for QVA149
Novartis has filed a marketing application with the EMA for its QVA149 indacaterol maleate/glycopyrronium bromide DPI for the treatment of COPD. The filing triggered milestone payments of $5 million each to the drug's developers, Vectura and Sosei. Vectura Chief Executive Chris Blackwell, “The IGNITE program is among the largest COPD clinical trial programs … [Read more...] about Novartis files MAA for QVA149
GSK launches inhaler recycling program in US
According to the Associated Press, GlaxoSmithKline is extending its "Complete the Cycle" inhaler recycling program to 31 US cities, which were chosen because they account for about a third of all inhaler sales in the US, the company said. Patients will be able to drop off used inhalers at approximately 2,000 pharmacies in those cities. A statement about inhaler … [Read more...] about GSK launches inhaler recycling program in US
Pearl completes Phase 2 program for PT003
According to Pearl Therapeutics, a randomized, double-blind, dose-ranging Phase 2b study of its PT003 formoterol fumarate (FF)/glycopyrrolate (GP) MDI for the treatment of moderate-to-severe COPD in more than a thousand patients showed that several doses of PT003 demonstrated superior bronchodilation compared to each of the components and to tiotropium. The … [Read more...] about Pearl completes Phase 2 program for PT003
MannKind announces public stock offering
On October 17, MannKind Corporation announced a plan to sell 40,000,000 shares of its common stock, plus warrants to purchase up to 30,000,000 shares, in a public offering, which it said may or may not be completed. Each share is being sold with a warrant, for a total price of $2.00/share. The funds raised will be used for on-going trials of Afrezza inhaled insulin. … [Read more...] about MannKind announces public stock offering
Alexza gets Global Enabling Technology Award from Frost & Sullivan
Market research firm Frost & Sullivan is presenting its 2012 Global Enabling Technology Award to Alexza Pharmaceuticals for its Staccato thermal vaporization inhaler platform. The award is designed to recognize a company for "developing a technology that enables the creation of new products and applications and/or enhances current products" along with the "potential … [Read more...] about Alexza gets Global Enabling Technology Award from Frost & Sullivan
PharmaForm moving to San Diego
Contract manufacturer PharmaForm, a subsidiary of Akela Pharma, has announced plans to move from Austin, TX to the San Diego, CA area. The company offers formulation and manufacturing services for numerous dosage forms, including nasal sprays and inhalation powders. PharmaForm President and CEO Rudy J. Emmelot commented, "We are excited about our move to San Diego … [Read more...] about PharmaForm moving to San Diego
MAP resubmits Levadex NDA
MAP Pharmaceuticals has resubmitted its New Drug Application (NDA) for Levadex inhaled dihydroergotamine for the treatment of migraine to the FDA, the company has announced. The FDA issued a complete response letter to MAP in March, 2012 and a form 483 to its contract manufacturer. MAP President and CEO Timothy S. Nelson said, "We have worked diligently on our … [Read more...] about MAP resubmits Levadex NDA
Chiesi announces positive Phase 1 results for its inhaled PDE4 inhibitor
According to Chiesi Group, a Phase 1 trial of its inhaled phosphodiesterase 4 (PDE4) inhibitor for the treatment of lung diseases such as COPD and asthma demonstrated that the drug, known as CHF 6001, was well tolerated in healthy volunteers at doses of up to 2000 µg for up to 7 days. In vitro and animal studies have shown that CHF 6001 is more potent than … [Read more...] about Chiesi announces positive Phase 1 results for its inhaled PDE4 inhibitor
NASA and Epiomed in deal to develop intranasal scopolamine
The United States' National Aeronautics and Space Administration (NASA) has signed a development and commercialization agreement with Epiomed Therapeutics for intranasal scopolamine. The nasal spray for the treatment of motion sickness is also called INSCOP. According to NASA, it has collected extensive data on motion sickness from the experience of astronauts in … [Read more...] about NASA and Epiomed in deal to develop intranasal scopolamine