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FDA approves mometasone nasal implant for chronic sinusitis

The FDA has approved a pre-market approval (PMA) application from Intersect ENT for its Propel mometasone furoate drug delivery implant for the treatment of chronic sinusitis. The dissolvable device is inserted in the sinus cavity during surgery and maintains the opening of the ethnoid sinus while it delivers the corticosteroid to the sinus lining. David W. … [Read more...] about FDA approves mometasone nasal implant for chronic sinusitis

NexBio reports clinical trial results for inhaled antiviral

NexBio, which was recently raided by the US Federal Bureau of Investigation (FBI), has announced results from a Phase 2 clinical trial of its Fludase inhaled antiviral for the treatment of influenza. According to the company, the dry powder formulation, also known as DAS181, demonstrated a significant reduction of viral load in patients infected with influenza. The … [Read more...] about NexBio reports clinical trial results for inhaled antiviral

MannKind and FDA agree on design of new inhaled insulin trials

After a meeting with the FDA, MannKind Corporation has announced that the company and the agency have confirmed protocols for new efficacy and safety studies of Afrezza inhaled insulin. The original studies of Afrezza were conducted with MedTone inhaler, and in May, the FDA asked MannKind to conduct new trials with the new Dreamboat inhaler in patients with type 1 … [Read more...] about MannKind and FDA agree on design of new inhaled insulin trials

Asthma drug costs more than doubled for US children over a decade

According to the US Health and Human Service Department's Agency for Healthcare Research and Quality (AHRQ), the average annual cost of prescription drugs to treat a child with asthma in the US rose from $349 to $838 over a ten-year period. The AHRQ study looked at costs in 1997-98 compared to 2007-08. Over the same period, the average overall cost of treatment … [Read more...] about Asthma drug costs more than doubled for US children over a decade

NanoBio moves intranasal vaccine into Phase 1 trials

Michigan-based biopharmaceutical company NanoBio has announced plans to advance its intranasal influenza vaccine into human trials after publishing results from a successful ferret study of the vaccine. The data gained from the ferret study appears in an article titled “Intranasal Immunization of Ferrets with Commercial Trivalent Influenza Vaccines Formulated in a … [Read more...] about NanoBio moves intranasal vaccine into Phase 1 trials

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

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