According to GlaxoSmithKline and Theravance, the two companies have now completed all studies for the Relovair fluticasone furoate (FF)/vilanterol (VI) DPI for both COPD and asthma, and they plan to move forward now with regulatory submissions. GSK had previously announced that it would submit marketing applications for Relovair despite the fact that the FF/VI … [Read more...] about GSK still going ahead with Relovair marketing applications
Medical
Inhaled gene therapy for CF study gets funding
A £3.1 million grant from the UK National Institute for Health Research (NIHR) and the Medical Research Council (MRC) will fund a gene therapy study in which 130 children and adults with cystic fibrosis will receive either an inhaled placebo or inhaled DNA delivered using lipids. The UK Cystic Fibrosis Gene Therapy Consortium (GTC) is coordinating the trial. The GTC … [Read more...] about Inhaled gene therapy for CF study gets funding
Teva announces positive Phase 3 results for QNASL dry nasal aerosol
Teva Pharmaceutical has announced positive results from four Phase 3 clinical studies of QNASL beclomethasone dipropionate HFA nasal aerosol for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Previously released data demonstrated that treatment with QNASL improved nasal symptom scores over the first 30 weeks of a 52-week … [Read more...] about Teva announces positive Phase 3 results for QNASL dry nasal aerosol
Positive Phase 3 results for Meda’s Dymista nasal spray
Meda has announced positive results from three studies of its Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. The company filed both an NDA for the product, currently known as MP29-02, and an MAA in 2011. One long-term study showed that the product is well tolerated, with fewer than 3% of patients … [Read more...] about Positive Phase 3 results for Meda’s Dymista nasal spray
NEJM: 200 years of asthma treatment
To celebrate its 200th anniversary, the New England Journal of Medicine (NEJM) is publishing a series of special articles reviewing progress in medicine since 1812. As part of the series, an article in the March 1, 2012 issue titled "A Patient with Asthma Seeks Medical Advice in 1828, 1928, and 2012" presents a fictionalized series of doctor's notes on the treatment … [Read more...] about NEJM: 200 years of asthma treatment
E-cigarette explodes in user’s mouth
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
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