Novartis has announced that its Phase III INSIST study shows that its once-daily Onbrez Breezhaler indacaterol DPI produces better bronchodilation in COPD patients than does twice-daily salmeterol. Onbrez also reduced the need for rescue medication, according to the data presented. The FDA has requested additional clinical data from Novartis for consideration of … [Read more...] about Phase III data shows Onbrez better for COPD than salmeterol
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Boston Scientific buys Asthmatx, hopes to expand use of bronchial thermoplasty
Boston Scientific has acquired Asthmatx, the developer of a bronchial thermoplasty procedure marketed as an alternative to inhaled medications for the treatment of severe asthma for an upfront payment of $193.5 million and future payments of up to $250 million. The Alair Bronchial Thermoplasty System, which was approved by the FDA in April 2010, uses heat to … [Read more...] about Boston Scientific buys Asthmatx, hopes to expand use of bronchial thermoplasty
Copley announces new version of CITDAS software
Version 3.10 of Copley Scientific's CITDAS inhaler testing software is now available, according to the company. The new version, available as a free upgrade for current CITDAS v3.00 users, includes automatic data importation from Waters Empower chromatography software. Read the company's press release. … [Read more...] about Copley announces new version of CITDAS software
Inavir DPI for influenza gets Japanese approval
Japan has approved Daiichi Sankyo's Inavir laninamivir dry powder inhaler for the treatment of influenza. Treatment with Inavir requires only a single inhaled 40 mg dose. Read the Daiichi Sankyo … [Read more...] about Inavir DPI for influenza gets Japanese approval
US survey finds support for regulation of e-cigarettes
A survey sponsored by the University of Michigan's C. S. Mott Children's Hospital found support for regulation of e-cigarettes, with 82% of the US adults polled agreeing that the FDA should regulate the products. Approximately 70% of respondents also thought that e-cigarettes should be banned in workplaces and should carry health warnings. Read the report. … [Read more...] about US survey finds support for regulation of e-cigarettes
MAP announces Levadex trial results
A PD study has shown no statistically significant difference in pulmonary artery pressure effects of Levadex inhaled dihydroergotamine (DHE) compared to placebo, according to MAP Pharmaceutical. The inhaled formulation had a smaller effect on pulmonary artery pressure than IV DHE. MAP has said that it intends to submit an NDA for Levadex for the treatment of … [Read more...] about MAP announces Levadex trial results
Prosonix launches co-crystal services
Prosonix has announced the availability of a new co-crystal development and processing service using its ultrasound technology for the manufacture of co-crystal APIs for inhalation products. According to the company, the process creates co-crystals with improved solubility and particle size distribution control. Read the company's press release. … [Read more...] about Prosonix launches co-crystal services
Marketing authorization for PecFent nasal spray
According to Archimedes Pharma, the European Commission has granted marketing authorization for the company's PecFent fentanyl nasal spray for the treatment of breakthrough pain in adult cancer patients. Archimedes submitted an NDA for the product to the US FDA in 2009 and is waiting for US approval. Read the company's press release. … [Read more...] about Marketing authorization for PecFent nasal spray
Quintiles to support Bronchitol commercialization
Quintiles has announced that it will provide commercialization services to Pharmaxis for the launch of Pharmaxis's Bronchitol mannitol DPI for the treatment of Cystic Fibrosis. Bronchitol has received orphan drug status in both Europe and the US, and Pharmaxis has filed an MAA with the EMA. Read the company's press release. … [Read more...] about Quintiles to support Bronchitol commercialization
Cypress Bioscience licenses two OINDPs
Cypress Bioscience of San Diego, California has aquired worldwide licensing rights for Alexza Pharmaceutical's Staccato Nicotine inhaler for smoking cessation. Alexza will receive $5 million up front, with another $1 million due upon meeting preclinical and clinical milestones. Read the company's press release. Cypress also announced that it purchased … [Read more...] about Cypress Bioscience licenses two OINDPs