According to news reports, a Florida man lost his teeth and part of his tongue when the battery in an e-cigarette exploded in his mouth on February 14. The explosion also started a fire in the man's home. Officials said that they were unable to determine the manufacturer of the e-cigarette. In October 2010, the US Court of Appeals ruled that the FDA has no … [Read more...] about E-cigarette explodes in user’s mouth
Medical
Herbal nasal sprays recalled
A Dallas, TX company called Wholistic Herbs Inc. has recalled all of the nasal spray products it distributed from March 2009 through February 2012 under the name "Koff & Kold" and "Kold Sore" after an FDA inspection determined that the products are not sterile. The products were distributed through the company's website, which is no longer accessible, and through … [Read more...] about Herbal nasal sprays recalled
Generic Symbicort fails to show equivalence
Finnish pharmaceutical company Orion Corporation has announced its intention to continue development of a generic budesonide/formoterol DPI despite the fact that "equivalence with the reference product, which is required under the guideline of the European Medicines Agency, was not reached" in recent studies. According to the company, study results received early this … [Read more...] about Generic Symbicort fails to show equivalence
Insmed moving ahead with Arikace trials despite FDA clinical hold
Insmed Incorporated has announced that it will go ahead with two clinical trials of its Arikace liposomal amikacin for inhalation for non-tuberculous mycobacteria (NTM) lung disease and for P. aeruginosa infections in CF patients despite the continuing clinical hold placed by the FDA on the latter application. The FDA lifted the hold on Arikace for NTM earlier … [Read more...] about Insmed moving ahead with Arikace trials despite FDA clinical hold
GSK tests Rotacaps inhaler versus Diskus for Advair
As GSK announced its 2011 results, which included sales declines for Advair (Seretide) in the US and Europe, and after the announcement that it plans to file a marketing application for its Relovair fluticasone furoate/vilanterol DPI despite disappointing data, Bloomberg took note of GSK's recent study of a cheaper capsule-based inhaler for delivery of Advair … [Read more...] about GSK tests Rotacaps inhaler versus Diskus for Advair
PhRMA report lists more than 50 drugs in US COPD pipeline
According to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA), American pharmaceutical companies have 54 COPD medications in their pipelines. The list of drugs in development includes all dosage forms, including a large number of inhaled medications. PhRMA President and CEO John J. Castellani commented, “Early detection of COPD is … [Read more...] about PhRMA report lists more than 50 drugs in US COPD pipeline
Recall of acetylcysteine inhalation solution
Bedford Laboratories has announced a national (US) voluntary product recall of acetylcysteine solution manufactured for Roxane Laboratories. The recall was initiated on December 20, 2011 due to a visible glass particle in a vial of solution from lot 1877093. According to the company, no adverse events have been reported. The company warned that "Use of an inhaled … [Read more...] about Recall of acetylcysteine inhalation solution
MHRA announces recall of contaminated saline nasal spray
Manufacturer Church & Dwight UK has informed the Medicines and Healthcare products Regulatory Agency (MHRA) of possible bacterial contamination of its Sterimar Isotonic 100ml saline nasal spray, which is available over the counter in the UK. The company has recalled two batches, numbers FE1248b and FE1249, identifying Pseudomonas stutzeri and Sphingomonas paucimobilis … [Read more...] about MHRA announces recall of contaminated saline nasal spray
Inverseon to focus on smoking cessation, COPD programs
California pharmaceutical company Inverseon has announced that it will redirect its development program for INV102, an inverse beta agonist, to focus on smoking cessation and COPD rather than asthma, although it is continuing to seek grants for development of the product as a treatment for asthma. Inverseon founder and Chair William Garner explained, “The … [Read more...] about Inverseon to focus on smoking cessation, COPD programs
Many patients with mild-to-moderate asthma may not respond to ICS
According to an article published online in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine, only about a third of asthma patients not using an inhaled corticosteroid (ICS) and 17% of those using ICS had eosinophils in their sputum, an indicator of inflammation that suggests they would likely respond to ICS treatment. The … [Read more...] about Many patients with mild-to-moderate asthma may not respond to ICS