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MedImmune submits supplemental biologics license application for new version of FluMist

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

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

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