August 2012
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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 . . .
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MannKind Corporation announced that the FDA has accepted the company’s sBLA for the use of Afrezza inhaled dry powder insulin in diabetes patients aged 4 to 17 and has set a PDUFA date of May 29, 2026.… Read more . . .
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German CDMO LTS Lohmann has announced that it will acquire US-based CDMO Renaissance Lakewood, which specializes in injectables and nasal sprays. According to the announcement, Renaissance currently employs approximately 500 employees. LTS currently offers services for… Read more . . .
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Inhalation CDMO Bespak has announced the appointment of former automotive industry executive Tarik Hage as Chief Commercial Officer. Hage was most recently VP of Commercial and Business Development at GKN Automotive, where he had worked… Read more . . .
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July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan
September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
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