December 2016
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Levo Therapeutics has announced that it plans to initiate a Phase 3 trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) before the end of 2018. The company said that it acquired… Read more . . .
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Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a… Read more . . .
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Novus Therapeutics said that it recently had a Type C meeting with the FDA regarding its OP-02 intranasal dipalmitoylphosphatidylcholine (DPPC)/cholesteryl palmitate (CP) suspension for the treatment of otitis media and has received confirmation of its… Read more . . .
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UK-based powder flow characterization specialist Freeman Technology has been acquired by US particle characterization instrument company Micromeritics, the companies have announced. Both companies offer instruments and services that can be used in development of OINDPs.… Read more . . .
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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 . . .
Featured event:
5th Annual Inhaled & Nasal Biologics | DNA Forum
5th Annual Inhaled & Nasal Biologics | DNA Forum
24th-25th September 2026, Cambridge, UK
Join us for a ground-breaking and insightful forum: Two days of cutting-edge talks and networking opportunities in this complex area of drug and vaccine development.
With renowned industry leaders who will share their insights and real-world case studies, our speakers will explore innovative formulation and delivery technologies and the rationale behind overcoming development challenges. Don’t miss out on this opportunity to learn more about key topics shaping the future of inhaled therapeutics.
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Upcoming Events
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland