According to Almirall, it has submitted a marketing authorization application to the European Medicines Agency (EMA) for its aclidinium bromide DPI for the treatment of COPD. Aclidinium bromide is a long-acting inhaled muscarinic antagonist; the dry powder formulation is delivered by the Genuair inhaler. Almirall and Forest Labs, which owns the US rights to the … [Read more...] about Almirall submits MAA for aclidinium bromide in Europe
News
Bend Research names Nightingale as president
Jim Nightingale has been promoted from Senior VP for Business Development and Strategic Alliances to President of drug development company Bend Research. Rod Ray is stepping down as President but will remain as CEO and chairman of the board. David Lyon, current VP of Research will assume the Business Development responsibilities. Until two years ago, Bend … [Read more...] about Bend Research names Nightingale as president
US sales of Cayston double
A small portion of Gilead's 11% increase in revenue for the second quarter of 2011 compared to the same quarter in 2010 is attributable to a 105% increase in the US sales of Cayston astreonam inhalation solution over that period. The company's revenues for the quarter totaled $2.14 billion. Sales of Cayston for the treatment of P. aeruginosa infections in cystic … [Read more...] about US sales of Cayston double
DDL and RDD abstract submission deadlines approaching
Abstract submission deadlines for the two largest scientific meetings of OINDP specialists are approaching rapidly. The 22nd Drug Delivery to the Lungs (DDL) meeting will take place December 7-9, 2011 in Edinburgh, UK; Respiratory Drug Delivery (RDD) 2012 will take place May 13-17, 2012 in Phoenix, AZ. Full abstracts for podium and poster submissions for DDL 22 … [Read more...] about DDL and RDD abstract submission deadlines approaching
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
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