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
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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
$38 million in financing for Civitas’s inhaled L-dopa program
Civitas Therapeutics will use $38 million in new financing for continued development of its CVT-301 inhaled L-dopa through Phase 3 clinical trials, the company has announced. A Phase 2B study of the drug, which is delivered using the Arcus DPI, was initiated earlier this month. Civitas is developing the Arcus API-only dry powder formulation of levodopa for the … [Read more...] about $38 million in financing for Civitas’s inhaled L-dopa program
Hovione granted new European patent for XCaps inhaler
The European Patent Office has granted a patent for the XCaps dry powder inhaler, Hovione has announced. The company filed for the patent in June 2011. Hovione VP Peter Villax, who co-invented the inhaler, commented, “We give our customers an edge in speed of development because we are perhaps the only independent company developing DPIs with expertise in every … [Read more...] about Hovione granted new European patent for XCaps inhaler