MedImmune has announced its submission of a supplemental Biologics License Application to the FDA for a version of its FluMist intranasal influenza vaccine that includes 4 strains of influenza virus as opposed to the usual 3 strains. The new version adds an additional influenza B strain and will include both B/Yamagata and B/Victoria, which have circulated recently, … [Read more...] about MedImmune submits supplemental biologics license application for new version of FluMist
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Insmed hires new General Counsel
Inhaled antibiotic developer Insmed has hired Andrea ("Andi") Holtzman Drucker as its Senior Vice President, General Counsel and Corporate Secretary, which is a newly-created position reporting directly to Insmed President and CEO Timothy Whitten. Drucker commented, "I am excited to be joining the Insmed management team, and look forward to working with the Company as … [Read more...] about Insmed hires new General Counsel
Patients using placebo inhalers report significant relief of symptoms
A study by Harvard researchers published in the New England Journal of Medicine found that patients reported similar relief of symptoms from use of a placebo inhaler compared to use of an albuterol inhaler. Although the albuterol inhaler resulted in significantly greater increase in FEV1 (20% vs. 7% for the placebo), the albuterol inhaler showed no significantly … [Read more...] about Patients using placebo inhalers report significant relief of symptoms
Researchers describe injectable system for drug delivery to the lung
University of South Florida researchers have successfully delivered an anti-inflammatory drug to the lower lungs of rats by injecting a formulation of Sertolli cells, chitosan nanoparticles, and curcumin into the rats' tails. Over 90% of the drug reached the pulmonary circulatory system within 15 minutes of injection. Sertolli cells, which are found in the testes, … [Read more...] about Researchers describe injectable system for drug delivery to the lung
Melbourn Scientific now offers manufacturing for clinical trials
After a successful audit by the UK MHRA, Melbourn Scientific has been issued a manufacturing license and now has the capability to manufacture OINDPs for use in Phase 1 and 2 clinical trials, according to the company's Director of Quality Carol Barbour. Melbourn already offers a range of analytical, inhaler testing, and formulation development services. “A … [Read more...] about Melbourn Scientific now offers manufacturing for clinical trials
New nebulizer integrated into ventilator
Aerogen has introduced a new nebulizer that is integrated into the Maquet SERVO-i ventilator. The high efficiency vibrating mesh Aeroneb nebulizer can be retrofitted to existing ventilators or purchased with new units. Aerogen CEO John Power commented “The potential for Aerogen’s advanced technology to reach the Maquet customer base is a very exciting one. We were … [Read more...] about New nebulizer integrated into ventilator
Relequa teams up with Elite Measurement
UK laboratory equipment company Elite Measurement Solutions is now distributing the Relequa Moisture Profiling System which determines equilibrium relative humidity for the optimization of dry powder and other formulations. Moisture profiling can provide information relevant to dry powder stability and aerosolization. The two companies will share a booth at DDL 22 in … [Read more...] about Relequa teams up with Elite Measurement
Aradigm gets additional funding from existing shareholders
Existing shareholders have agreed to purchase additional Aradigm Corporation common stock for a total of $4.75 million. The three shareholders will pay $0.19 per share for 25 million shares. The net proceeds for Aradigm after fees and expenses should be about $4.4 million. "We are very pleased for the support demonstrated by our shareholders in this private … [Read more...] about Aradigm gets additional funding from existing shareholders
European marketing approval for single dose Instanyl nasal spray
The European Commission has granted marketing authorization for Nycomed's single dose Instanyl fentanyl nasal spray for the treatment of breakthrough pain in cancer patients. A multi-dose Instanyl product was approved by the EC in 2009 and is marketed in 50, 100, and 200 mcg dose versions. The single dose Instanyl will be available in the same dosages. "The launch … [Read more...] about European marketing approval for single dose Instanyl nasal spray
FDA approves indacaterol
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