August 2012
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The FDA has accepted Glenmark Pharmaceuticals’ NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, with the PDUFA date for completion of the review set for March 21, 2019,… Read more . . .
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Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium (GTC), Imperial Innovations, and Oxford BioMedica have formed a partnership for development of an inhaled therapy designed to introduce a healthy copy of the CFTR gene… Read more . . .
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According to DFE Pharma, the company has significantly increased production capacities of its excipients, including all of its inhalation grade lactose products. The company said that it achieved the improved supply through investments at facilities… Read more . . .
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Cohero Health has announced 5 new hires “to scale for growth and drive commercial sales of its BreatheSmart platform.” In 2016, Cohero and H&T Presspart announced that they had partnered on development of an electronic… Read more . . .
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During its second quarter earnings call on July 24, 2018, Eli Lilly announced that it had filed regulatory submissions with the FDA and with the EMA for its intranasal glucagon for the treatment of severe… Read more . . .
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MannKind Corporation has signed an agreement with Tanner Pharma Group for distribution of Afrezza inhaled insulin in regions outside of the US, the company said. The agreement covers regions where Afrezza is not yet approved,… Read more . . .
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Savara has acquired rights to an amikacin/fosfomycin inhalation solution that was being developed by Cardeas Pharma for the treatment of ventilator associated pneumonia and has appointed former Cardeas Pharma CEO A. Bruce Montgomery as a… Read more . . .
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According to Adherium, the FDA has granted 510(k) clearance for OTC sales of the company’s Hailie adherence monitoring sensor for use with several MDIs for the treatment of asthma. In March 2018, the FDA granted… Read more . . .
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I am sure that I was not alone to conclude after the 2018 Respiratory Drug Delivery Conference that the most profoundly important session was “Exploring the Benefits of Smart Inhalers on Public Health.” And I… Read more . . .
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After meeting with the FDA regarding the clinical program for US approval of its Penthrox methoxyflurane inhaler, Medical Developments International (MVP) said that it expects to receive a clinical hold letter from the agency within… Read more . . .
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