Avanir Pharmaceuticals has published results of a pharmacokinetic study of its AVP-825 intranasal sumatriptan powder for the treatment of acute migraine. Avanir licensed AVP-825 from OptiNose in July 2013, and the powder is delivered using the OptiNose breath-activated intranasal device. The study, published in Headache, compared AVP-825 to liquid nasal spray, oral … [Read more...] about Avanir publishes data on intranasal sumatriptan
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Ultibro inhalation capsules approved in Japan
Sosei Group and Vectura have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Ultibro glycopyrronium/indacaterol inhalation capsules, which are delivered using the Breezhaler DPI, for treatment of COPD. Ultibro, also known as QVA149, was developed by Novartis, which filed the Japanese marketing application in November 2012. … [Read more...] about Ultibro inhalation capsules approved in Japan
Relvar Ellipta recommended for approval by CHMP, approved in Japan
GlaxoSmithKline and Theravance have announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of asthma for patients who require a combination inhaler for adequate control and for the treatment of COPD patients with … [Read more...] about Relvar Ellipta recommended for approval by CHMP, approved in Japan
Mundipharma launches Flutiform trial for COPD
A Phase 3 trial of Flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of COPD has been initiated, according Mundipharma. The 52-week randomized, double-blind EFFECT study compare Flutiform 250/10 μg and Flutiform 125/5 μg with formoterol 12 μg. Flutiform is approved in Europe for the treatment of asthma; it is not approved for the treatment of … [Read more...] about Mundipharma launches Flutiform trial for COPD
Medivir to market Adasuve inhaled loxapine in Nordic countries
Medivir AB has entered into a license agreement with Ferrer for exclusive rights to commercialize Adasuve inhaled loxapine in Denmark, Finland, Norway, Iceland and Sweden. The company is paying Ferrer an undisclosed amount up front, plus sales-based milestone payments. Medivir CEO Maris Hartmanis commented, “This licensing agreement is in line with our strategy … [Read more...] about Medivir to market Adasuve inhaled loxapine in Nordic countries
Mystic Pharmaceuticals gets US patents for intranasal delivery platforms
The US Patent and Trademark Office (USPTO) has issued notices of allowance for two Mystic Pharmaceuticals patents related to its VersiDoser and VRx2 intranasal delivery platforms. The VersiDoser platform is used for packaging and aerosol delivery of liquid formulations; the VRx2 platform can be used for powder formulations. The patent applications are titled “Unit … [Read more...] about Mystic Pharmaceuticals gets US patents for intranasal delivery platforms
AANMA President Nancy Sander retires
According to the Allergy & Asthma Network Mothers of Asthmatics (AANMA), President and Founder Nancy Sander has retired. Sander founded the patient advocacy organization in 1985. Over the course of her tenure with AANMA, Sander advocated for legal and regulatory changes to benefit asthma patients, including the FDA guidance for dose counters on inhalers. … [Read more...] about AANMA President Nancy Sander retires
Chiesi to acquire Cornerstone Therapeutics
Chiesi Farmaceutici will acquire all outstanding shares of Cornerstone Therapeutics for $9.50 per share, the companies have announced. Chiesi already owns almost 60% of Cornerstone outstanding common shares. Cornerstone announced in February 2013 that it had received an offer of between $6.40 and $6.70 per share from Chiesi. According to Chiesi, "The acquisition … [Read more...] about Chiesi to acquire Cornerstone Therapeutics
Sigma Tau to manufacture Aradigm’s Pulmaquin inhaled ciprofloxacin
Sigma-Tau PharmaSource and Aradigm have announced that Sigma-Tau PharmaSource will provide clinical and commercial manufacturing services for Aradigm's Pulmaquin inhaled ciprofloxacin. Pulmaquin is in Phase 3 development for the treatment of non-cystic fibrosis bronchiectasis. Terms of the agreement were not disclosed. Sigma-Tau Pharmaceuticals CEO Dave Lemus … [Read more...] about Sigma Tau to manufacture Aradigm’s Pulmaquin inhaled ciprofloxacin
Activaero and Chiesi to collaborate on inhaled CF drug
Activaero has announced that it will collaborate with Chiesi Farmaceutici on an inhaled treatment for cystic fibrosis that would deliver a Chiesi drug using Activaero's FAVORITE (Flow And Volume Regulated Inhalation Technology) system. Financial details were not disclosed. According to Activaero, the initial portion of the collaboration should be complete by the end … [Read more...] about Activaero and Chiesi to collaborate on inhaled CF drug