News
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Insys Therapeutics said that preliminary data from a Phase 1 pharmacokinetics study comparing its intranasal epinephrine formulation to EpiPen intramuscular epinephrine in 60 subjects with seasonal allergies showed similar bioavailability and rapid drug absorption for… Read more . . .
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Insmed has announced that the FDA’s Division of Antimicrobial Products has set an advisory committee meeting for August 7, 2018 for review of the company’s NDA for ALIS amikacin liposome inhalation suspension for the treatment… Read more . . .
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Recipharm will pay £45 million to Sanofi to acquire Sanofi’s UK inhalation contract manufacturing facility and business “in a bid to expand its inhalation capabilities.” The 125,000 sq m facility in Holmes Chapel has more… Read more . . .
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Mylan has announced that it was informed by the FDA on June 13, 2018 that the agency will issue a complete response letter regarding Mylan’s ANDA for its generic Advair Diskus fluticasone/salmeterol DPI on June… Read more . . .
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Former Mylan Senior Director of Inhalation Biopharmaceutics Per Bäckman has joined Emmace Consulting as Senior Inhalation Consultant, the company has announced. Bäckman also previously held various positions at AstraZeneca, including as Principal Scientist in Inhalation… Read more . . .
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Data from a Phase 1 study of Pulmatrix’s PUR0200 lactose-free dry powder formulation of tiotropium has been published online in the British Journal of Clinical Pharmacology. The dose-ranging study in patients with moderate-to-severe COPD compared… Read more . . .
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Lupin has launched its generic version of Tobi inhalation solution in the US, the company said. The FDA granted final approval of Lupin’s ANDA for its tobramycin inhalation inhalation solution in March 2017. The 300… Read more . . .
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MannKind Corporation has announced that a previously announced Phase 1 study of its Treprostinil Technosphere (TreT) DPI in healthy volunteers has met its primary endpoint of safety and tolerability, and the company is now preparing… Read more . . .
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Spyryx Biosciences has announced that data from the first cohort of the Phase 2 HOPE-1 (Hydration for Optimal Pulmonary Effectiveness) study, which was initiated in October 2017, demonstrate improvement in lung function for cystic fibrosis… Read more . . .
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Evoke Pharma has submitted a 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, the company said. Earlier this year, Evoke announced that it had… Read more . . .
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