Vectura's VR496, an inhaled dry powder formulation of heparin sodium, has produced positive results in a Phase 2 study in cystic fibrosis patients, says the company. The product has received orphan drug status from both the EMA and the FDA. The study involved 77 CF patients, with 90% completing the 4-week treatment period. Patients treated with VR496 experienced … [Read more...] about Positive results for Vectura inhaled heparin formulation
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Study shows tiotropium better than salmeterol for preventing COPD exacerbations
Results from the Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD) study published in the New England Journal of Medicine show a significant reduction in exacerbations for COPD patients treated with tiotropium compared to those treated with salmeterol. The one-year study involved almost 7400 patients with moderate to severe COPD, half of whom were … [Read more...] about Study shows tiotropium better than salmeterol for preventing COPD exacerbations
FDA extends review period for QAB149 (indacaterol)
The FDA has informed Novartis that it needs a three-month extension for its review of data supporting the company's NDA for QAB149 (indacaterol). The new completion date for the review would be July 2011. The agency's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of approving a 75 mcg dose of the drug but against approval of a 150 mcg … [Read more...] about FDA extends review period for QAB149 (indacaterol)
Verona announces £1.89 million loss for 2010
According to Verona Pharma, the company spent nearly £1 million in 2010 on development of its lead product, RPL554, an inhaled PDE3/4 inhibitor for the treatment of asthma, COPD, and allergic rhinitis. Those R&D costs contributed to a £1.89 million loss for the year. Verona's preliminary unaudited results statement reports that the company is in discussions with … [Read more...] about Verona announces £1.89 million loss for 2010
US Supreme Court rules against Matrixx in Zicam case
The US Supreme Court ruled unanimously that Matrixx Initiatives was wrong when it claimed that it did not have to disclose reports of adverse effects caused by its Zicam nasal spray because the number of reports was statistically insignificant. Matrixx is being sued by investors for securities fraud for failing to reveal reports that the product had caused some … [Read more...] about US Supreme Court rules against Matrixx in Zicam case
Insmed gets clearance for Phase 3 Arikace trial
According to Virginia biotech company Insmed, the US FDA has cleared the company's Investigational New Drug (IND) application for a Phase 3 trial of its Arikace liposomal amikacin for inhalation in nontuberculous mycobacteria lung infections. Arikace is delivered using a custom PARI eFlow nebulizer system. Renu Gupta, Insmed's Executive Vice President Development … [Read more...] about Insmed gets clearance for Phase 3 Arikace trial
Novartis to maintain respiratory research at Horsham
According to reports, Novartis will close its manufacturing facility at Horsham, UK, cutting 550 jobs, but will maintain its respiratory research program at the site. The company employs approximately 330 researchers in the respiratory program. Novartis opened the £42 million Respiratory Research Centre in 2001. Read a report from the BBC. … [Read more...] about Novartis to maintain respiratory research at Horsham
New asthma impact survey suggests high inhaler usage
The Allergy and Asthma Network Mothers of Asthmatics (AANMA) has published results of a new survey of US asthma patients. Of the patients surveyed, 100% reported use of a short-acting bronchodilator, and 95% reported that they use some form of inhaled corticosteroid (ICS). The high percentage of patients reporting use of inhaled medications is particularly … [Read more...] about New asthma impact survey suggests high inhaler usage
Omalizumab reduces need for inhaled asthma drugs
An article published in the March 17, 2011 issue of the New England Journal of Medicine details a study by researchers from the Boston University School of Medicine showing that omalizumab reduces the need for inhaled medications in inner-city children with asthma. Omalizumab is a monoclonal anti-IgE antibody. The 60-week randomized, double-blind study involved … [Read more...] about Omalizumab reduces need for inhaled asthma drugs
Sativex spray now available in Spain
Almirall has launched Sativex oro-mucosal spray for the treatment of spasticity in multiple sclerosis patients in Spain. Sativex is an endocannabinoid modulator that contains THC and cannabidiol developed and manufactured by GW Pharmaceuticals. According to the company approximately 75% of the 40,000 MS patients in Spain suffer from spasticity. The product will be … [Read more...] about Sativex spray now available in Spain