The FDA has issued a complete response letter to MAP Pharmaceuticals' NDA for Levadex dihydroergotamine inhalation aerosol for the treatment of migraine headaches. According to MAP, "the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. … [Read more...] about MAP gets complete response letter for Levadex inhaled dihydroergotamine
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Engineering firm discloses DPI filling technology
A Massachusetts engineering firm called Enginasion has disclosed details of proprietary DPI-filling technology it says that it developed for a pharmaceutical client that needed accurate dispensing of a highly cohesive inhaled dry powder formulation into cartridges. Enginasion Founder and CEO David Bonneau is the co-author of several patents assigned to MannKind … [Read more...] about Engineering firm discloses DPI filling technology
FDA approves QNASL HFA nasal aerosol
According to Teva, the FDA has approved its QNASL HFA beclomethasone dipropionate nasal aerosol for the treatment of seasonal and perennial allergic rhinitis in adults and children 12 years of age and older, and the company plans to launch the product by the end of April 2012. QNASL is delivered by a pressurized nasal delivery device that includes a dose counter. Teva … [Read more...] about FDA approves QNASL HFA nasal aerosol
Almirall publishes full results from aclidinium bromide study
Almirall has published full results from the ATTAIN (Aclidinium To Treat Airway obstruction In COPD patieNts) study in The European Respiratory Journal (ERJ). ATTAIN was a six-month double-blind placebo-controlled study that compared two doses of inhaled aclidinium (200μg and 400μg twice daily) to placebo in patients with COPD. According to the company the 400 µg dose … [Read more...] about Almirall publishes full results from aclidinium bromide study
GSK still going ahead with Relovair marketing applications
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
Next Breath now a WHO PQS accredited facility for nasal spray vaccine testing
OINDP testing specialist NextBreath has successfully completed an evaluation by the World Health Organization (WHO) Performance Quality System (PQS) as a testing facility for nasal spray vaccine administration. The company is now accredited to perform analytical testing of PQS products, making it one of only two accredited labs in the US and one of only eleven … [Read more...] about Next Breath now a WHO PQS accredited facility for nasal spray vaccine testing
Ablynx extends its alliance with Boehringer Ingelheim
Belgian biopharmaceutical company Ablynx has announced that Boehringer Ingelheim will extend funding for discovery, development, and commercialization of Ablynx's Nanobody therapeutics for an additional two years, until September 2014. One of the Ablynx programs ALX-0171, which began Phase 1 trials in December 2011, is an inhaled therapy for respiratory syncytial … [Read more...] about Ablynx extends its alliance with Boehringer Ingelheim
Astepro nasal spray approved in Europe
Meda has announced that its Astepro azelastine nasal spray for the treatment of allergic rhinitis has received registration approval in Europe through the centralized procedure and that it will now begin the national registration processes in individual countries in anticipation of a 2013 launch. Earlier this year, Meda filed suit against Apotex and Perrigo in the US … [Read more...] about Astepro nasal spray approved in Europe
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
Novartis launches the Arcapta Neohaler in the US
Novartis has launched its once-daily Arcapta Neohaler indacaterol inhalation powder 75 mcg for the maintenance treatment of COPD in the US. The FDA approved the indacaterol product at the 75 mcg level in July 2011 but rejected higher doses. The agency explained its reasoning in an article in the New England Journal of Medicine in December 2011. In Europe, where … [Read more...] about Novartis launches the Arcapta Neohaler in the US