Moerae Matrix has announced the initiation of a Phase 1 clinical trial of MMI-0100, an inhaled MAPKAP Kinase 2 (MK2) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF). In June 2012, the company announced an agreement with MicroDose Therapeutx (now part of Teva) to develop a dry powder inhalation delivery system for the drug. Moerae Matrix CEO … [Read more...] about Phase 1 study of Moerae Matrix’s inhaled MK2 inhibitor initiated
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OptiNose raises funds for development of intranasal fluticasone
According to OptiNose, the company has completed a Series C-1 round of financing that will support development of its second product, OPN-375 intranasal fluticasone. The company, along with partner Avanir, submitted an NDA for its first product, AVP-825 intranasal sumatriptan for the treatment of migraine, in January 2014. According to the company, its … [Read more...] about OptiNose raises funds for development of intranasal fluticasone
Insmed to proceed with Phase 3 study of Arikayce, will file MAA in 2014
Insmed has announced that it will move ahead with a Phase 3 trial of Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung infections, with results expected in 2017. According to the company, it met with the FDA regarding the study, and "the FDA acknowledged that exploration of the effectiveness of Arikayce in a broader … [Read more...] about Insmed to proceed with Phase 3 study of Arikayce, will file MAA in 2014
Alexza announces plans for development of inhaled ropinirole
Alexza Pharmaceuticals has announced that it will develop Staccato versions of ropinirole, a dopamine agonist, for the treatment of restless leg system (AZ-008) and for the treatment of hypomobility during OFF episodes in Parkinson's disease (AZ-009). The Staccato system uses heat to aerosolize pure API for inhalation. The company said that it also plans to begin a … [Read more...] about Alexza announces plans for development of inhaled ropinirole
Striverdi Respimat approved by the FDA
The FDA has announced the approval of Boehringer Ingelheim's Striverdi Respimat olodaterol SMI for the treatment of COPD. The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of Striverdi Respimat in January 2013. The soft mist inhaler was approved in the EU in October 2013. Curtis Rosebraugh, Director of the Office of Drug Evaluation … [Read more...] about Striverdi Respimat approved by the FDA
Mystic Pharmaceuticals gets notice of allowance for dry powder delivery tech patent
Mystic Pharmaceuticals has announced that the United States Patent and Trade Office issued a Notice of Allowance for the company's patent application titled “Medical Devices For Dispensing Powders” (application #13/433,586). The technology is an extension of the company's VRx2 delivery platform and can be used for nasal, buccal, sublingual and opthalmic powder … [Read more...] about Mystic Pharmaceuticals gets notice of allowance for dry powder delivery tech patent
AstraZeneca acquires rights to Almirall’s respiratory business
AstraZeneca will pay $875 million initially, plus up to an additional $1.22 billion to acquire development and commercialization rights to Almirall's entire respiratory drug business. Almirall's respiratory products include the Eklira/Bretaris/Tudorza aclidinium DPI, an aclidinium/formoterol DPI, and several other inhaled drugs in development. The company's inhalation … [Read more...] about AstraZeneca acquires rights to Almirall’s respiratory business
Malvern adds new particle characterization system
Malvern Instruments has announced the purchase of the Archimedes particle characterization system from Affinity Biosensors after having had an exclusive distribution agreement outside of North America and a co-marketing agreement in North America for the past two years. The system, including the intellectual property associated with it, is now fully owned by … [Read more...] about Malvern adds new particle characterization system
FDA approves Flonase for over the counter sales
GlaxoSmithKline has announced that the FDA has approved its Flonase fluticasone propionate nasal spray for the treatment of allergic rhinitis for over-the-counter sale. The approval is for a 50 mcg spray, the same as the current prescription strength. According to GSK, Flonase Allergy Relief will be available over the counter in the US in early 2015. GSK … [Read more...] about FDA approves Flonase for over the counter sales
Milestone Pharmaceuticals appoints Francis Plat as Chief Medical Officer
Canadian pharmaceutical company Milestone Pharmaceuticals, which is developing an intranasal short-acting calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia, has announced the appointment of Francis Plat as Chief Medical Officer. Dr. Plat commented, "I am highly enthused to join Milestone in its development of MSP-2017, a … [Read more...] about Milestone Pharmaceuticals appoints Francis Plat as Chief Medical Officer