Diabetes research organization JDRF, along with Sansum Diabetes Research Institute, and the College of Engineering at University of California, Santa Barbara (UCSB) have announced positive results from a trial of an artificial pancreas used in conjunction with inhaled insulin taken at mealtimes. In 2010, MannKind Corporation announced that it would provide Afrezza … [Read more...] about Positive results in artificial pancreas plus inhaled insulin study
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European approval for Ultibro Breezhaler
Just days after its approval in Japan, Novartis has announced that the Ultibro Breezhaler indacaterol/glycopyrronium (QVA149) DPI has been approved in Europe for the treatment of COPD. The approval triggers $10 million milestone payments to Sosei and Vectura. Novartis Pharmaceuticals Division Head David Epstein commented, "We are very pleased that the European … [Read more...] about European approval for Ultibro Breezhaler
Positive opinion on Fluenz Tetra from CHMP
According to AstraZeneca, it has received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) for its Fluenz Tetra intranasal four-strain live attenuated influenza vaccine developed by its MedImmune subsidiary. Fluenz Tetra includes two strains of influenza A and two strains of influenza B. If approved, the vaccine would replace … [Read more...] about Positive opinion on Fluenz Tetra from CHMP
Avanir publishes data on intranasal sumatriptan
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
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