News
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According to California-based start-up CounterAct, the FDA has approved of the company’s approach regarding potential approval of its naloxone nasal spray cap. The CounterAct cap is a plastic device that snaps onto the top of… Read more . . .
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Swiss CDMO Micro-Sphere has announced the addition of new DPI capsule filling capacity with a new MG2 Tekna filling machine in a dedicated, humidity-controlled cleanroom at its facility near Lugano. The company also has added… Read more . . .
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Aptar Pharma has announced that it will officially launch its new PureHale aerosol device at CPhI Worldwide. Purehale, a bag-on-valve “nebulizer-like device,” is a finalist for the CPhI Pharma Awards in the drug delivery device… Read more . . .
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The FDA has approved Insmed’s amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in a limited population of patients. Arikayce, which Insmed had recently… Read more . . .
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United Therapeutics will pay Samumed $10 million up front and up to $340 million in milestones, plus royalties, for North American rights to Samumed’s SM04646, a Wnt signaling pathway inhibitor that in in Phase 1… Read more . . .
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Inhaled insulin developer Dance Biopharm has announced the appointment of former Novoclem Pharmaceuticals President and CEO Anne Whitaker as a Director and CEO as of October 1st, 2018. In addition to founding and heading up… Read more . . .
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DPI developer TFF Pharmaceuticals has received a communication from the European Patent Office (EPO) in regards to its patent application No. 08771657.7 “Formation of Stable Submicron Peptide or Protein Particles by Thin Film Freezing,” giving… Read more . . .
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According to Neurelis, the company has submitted an NDA for its diazepam nasal spray, now called Valtoco, for the treatment of cluster seizures in epilepsy patients aged six years and older. The nasal spray, previously… Read more . . .
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According to Senzer, a PK study conducted by Insys Therapeutics found that a 0.35 mg dose of dronabinol delivered by Senzer’s Voke inhaler achieved a similar maximum concentration as a 5.0 mg dose of Marinol… Read more . . .
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Just weeks after Janssen announced that it had submitted an NDA for its intranasal esketamine for the treatment of depression, the company has presented data from a Phase 3 trial of the nasal spray that… Read more . . .
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