Calls for papers
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The EMA has announced that its Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding a marketing authorization application submitted by Teva Pharma B.V. for a budesonide/formoterol DPI for the… Read more . . .
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Pulmatrix has announced that its Pulmazole (PUR1900) dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma has received Fast Track designation from the FDA. The company initiated a Phase… Read more . . .
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According to Novartis’s 2019 annual report, Novartis subsidiary Sandoz has discontinued development of a generic version of the Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma and COPD for the US market as… Read more . . .
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Pulmotect has announced that preclinical testing in mouse models has demonstated that a single dose of its PUL-042 inhaled immunostimulant, which is made up of Toll-like receptor ligands, could protect against infection by SARS-associated coronavirus… Read more . . .
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The UK’s National Institute for Health and Care Excellence (NICE) has announced that it is not recommending the use of Janssen’s Spravato esketamine nasal spray for the treatment of treatment-resistant depression due to concerns about… Read more . . .
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According to Hovione Technology, the company has received patent grants for its TwinMax large dose DPI in a number of new territories. CEO Peter Villax said, “We achieved unchallenged patent grants for TwinMax in the… Read more . . .
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Liquidia Technologies said that it has submitted a 505(b)(2) NDA for its LIQ861 inhaled dry powder treprostinil for the treatment of pulmonary arterial hypertension (PAH). The company announced in March 2019 that the Phase 3 INSPIRE… Read more . . .
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Cognita Labs has received FDA clearance for its CapMedic digital inhaler sensor for use with metered dose inhalers, the company said. The CapMedic device, which fits over the top of the MDI actuator and includes… Read more . . .
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Days after announcing that the FDA has accepted its NDA resubmission for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, Evoke Pharma said that the company has cancelled a previously announced commercialization deal… Read more . . .
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Health Canada has approved Baqsimi intranasal dry powder glucagon for the treatment of severe hypoglycemia in patients with Type 1 or Type 2 diabetes, Eli Lilly Canada has announced. Baqsimi is now available in Canadian… Read more . . .
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