Calls for papers
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Tonix Pharmaceuticals announced that Massachusetts General Hospital has initiated a Phase 1 trial called FOCUS to evaluate Tonix’s TNX-1900 and TNX-2900 oxytocin nasal sprays in patients with arginine-vasopressin deficiency (central diabetes insipidus). The FOCUS study… Read more . . .
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GSK has announced that a Phase 3 trial comparing an HFA-152a formulation of Ventolin salbutamol (albuterol) MDI to the currently marketed HFA-134a formulation demonstrated therapeutic equivalence. The company also said that safety of the LGWP propellant… Read more . . .
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OINDP specialist CDMO Kenox Pharmaceuticals has announced the appointment of Julianne Berry as VP of R&D and Manufacturing. Berry was most recently VP, Respiratory Product Development at Odin Pharmaceuticals and has extensive experience in the development of inhaled… Read more . . .
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Italian biotech Dompé announced that the US FDA has awarded a voucher under the new Commissioner’s National Priority Voucher (CNPV) pilot program for accelerated review of an application for the company’s intranasal cenegermin-bkbj (recombinant human… Read more . . .
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Orbia has announced the delivery of 17 tonnes of Koura Global’s Zephex 152a (HFA-152a), an LGWP propellant, to Kindeva Drug Delivery‘s facility in Loughborough, UK where the CDMO has MDI manufacturing lines for LGWP propellants. Kindeva… Read more . . .
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According to Beckley Psytech and atai Life Sciences, the FDA has granted Breakthrough Therapy designation to Beckley’s BPL-003 intranasal mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression. Earlier this year, the companies announced that a Phase… Read more . . .
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Viatris announced that it has acquired Aculys Pharma, which in 2022 had acquired development and commercialization rights to Neurelis’s NRL-1 (Valtoco) intranasal diazepam for the treatment of epilepsy in Japan, Australia, and other Asia-Pacific countries. In… Read more . . .
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US-based biotech Eradivir announced that a Phase 1/2a trial of its EV25 intranasal antiviral for the treatment of influenza demonstrated that a single 300 mg dose resulted in a significant reduction in lower respiratory tract… Read more . . .
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The FDA has granted 510(k) clearance to Aptar Digital Health’s HeroTracker Sense MDI sensor, the company said. Aptar acquired the sensor’s developer, Cohero Health, in 2020 and launched the Bluetooth-enabled sensor in 2022. According to the… Read more . . .
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According to Chiesi, the FDA has accepted the company’s NDA for its CHF5993 beclomethasone dipropionate /formoterol fumarate / glycopyrrolate MDI for the treatment of asthma. In April 2024, Chiesi announced that it was initiating a… Read more . . .
Upcoming Events
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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