August 2012
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Endo USA has recalled all unexpired lots of Adrenalin Chloride Solution epinephrine nasal solution, which is meant for topical application, due to FDA concerns about the potential for confusion of the product with the company’s… Read more . . .
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Aridis Pharmaceuticals said that “an undisclosed pharmaceutical company” has agreed to pay $6.5 million plus annual royalty payments for Aridis’ AR-501 nebulized gallium for the treatment of chronic lung infections in patients with cystic fibrosis.… Read more . . .
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The US Court of Appeals for the Federal Circuit has upheld a ruling from district court that requires Teva to remove patents covering inhaler device and dose counter IP from the FDA’s Orange Book. In… Read more . . .
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DDL 2024 drew the largest crowd ever in the 35-year history of the Drug Delivery to the Lung (DDL), with more than 100 OINDP experts attending online and approximately 1,000 attending in person at the… Read more . . .
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Savara announced that it has initiated a rolling biologics license application submission for its Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company said that it will request priority review… Read more . . .
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According to PureIMS, both the EMA and FDA have recently granted orphan drug designation to the company’s Colistin Cyclops dry powder inhaler for the treatment of P. aeruginosa infections in cystic fibrosis patients. Colistin Cyclops is… Read more . . .
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Intranasal drug developer Orexo and Swedish vaccine developer Abera Bioscience have announced that they will collaborate on development of intranasal dry powder vaccines based on Orexo’s AmorphOX powder engineering technology and Abera’s vaccine platform, starting… Read more . . .
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ARS Pharmaceuticals has announced that its partners in China, Japan, and Australia have all submitted marketing applications for approval of neffy epinephrine nasal spray for the treatment of serious allergic reactions in their respective countries. ARS is… Read more . . .
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According to MannKind Corporation, the Indian Central Drugs Standard Control Organization (CDSCO) has approved a marketing application submitted by Cipla for Afrezza inhaled dry powder insulin for the treatment of diabetes in adults. Cipla acquired the… Read more . . .
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Merxin Ltd and contract device manufacturer OECHSLERhealth have announced the formation of a strategic partnership called The SMI PowerHouse for manufacturing of Merxin’s MRX004 soft mist inhaler, a generic version of the Respimat device. According… Read more . . .
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