August 2012
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The FDA recently published a new product specific draft guidance for inhaled dry powder loxapine for development of generic versions of Adasuve loxapine inhalation powder, which was approved by the agency in December 2012 for… Read more . . .
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Satsuma Pharmaceuticals said that the FDA has accepted the company’s 505(b)(2) NDA for STS101 nasal powder dihydroergotamine for the treatment of migraine, and Satsuma expects the agency to set a PDUFA goal date in January… Read more . . .
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CounterAct has announced results from a human factors / usability study of its nasal spray cap device that included a simulated rescue in an opioid overdose scenario. The CounterAct device, which is designed to snap… Read more . . .
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At RDD Europe 2023, which took place May 2-5 in Antibes, France, Richard Dalby noted in his opening remarks that approximately 420 inhaled and nasal drug delivery experts from 28 countries were attending the conference… Read more . . .
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CDMO Experic announced that it is adding a pilot scale spray dryer spray at its facility in Cranbury, NJ, USA, extending the company’s DPI formulation development capabilities. According to Experic, installation and validation of the new… Read more . . .
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Nebulizer manufacturer PARI announced that it has acquired equine nebulizer maker Nortev in a deal that the company suggested “opens attractive synergy potential.” Nortev will continue to operate independently, the company said. According to PARI,… Read more . . .
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The FDA’s Pulmonary-Allergy Drug Advisory Committee (PADAC) voted at its May 11, 2023 meeting in support of approval of ARS Pharmaceuticals’ Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, the company announced. Committee members voted… Read more . . .
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SoftOx Solutions has announced a restructuring plan that includes shutting down its own GMP facility, laying off employees, and outsourcing further development of its SoftOx inhalation solution (SIS) to the University of Copenhagen. The company… Read more . . .
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Lumen Bioscience said that it has received a contract worth $8.8 million from the Defense Innovation Unit (DIU) of the US Department of Defense for development of “a prototype broad-spectrum, fast-acting intranasal powder for treatment and prevention… Read more . . .
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Codagenix announced that it has initiated a Phase 1 study of its CodaVax-RSV live-attenuated intranasal vaccine candidate in children aged 6 months to 5 years, with the study expected to enroll 18 children aged 2… Read more . . .
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