December 2016
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The FDA has accepted Insned’s NDA for ALIS (amikacin liposome inhalation suspension) for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), with a PDUFA date of September 28, 2018,… Read more . . .
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The FDA informed Perrigo during a May 10, 2018 teleconference that the agency will issue a complete response letter to the company’s ANDA for its generic version of Teva’s ProAir albuterol MDI, Perrigo said. As… Read more . . .
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MannKind Corporation announced that it has signed a deal with Cipla for marketing and distribution of Afrezza inhaled insulin in India. Cipla will be responsible for getting regulatory approval in India and will pay MannKind… Read more . . .
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The Medical Devices Group at the University of Cape Town has designed a device to significantly reduce the force required to actuate an inhaler, the university has announced. The device, called “Easy Squeezy,” fits over… Read more . . .
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TFF Pharmaceuticals, which recently announced that it had raised $14 million for the development of DPI formulations, has named former Arno Therapeutics CEO Glenn Mattes as its new Chief Executive Officer. Mattes’s career includes management… Read more . . .
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US biopharmaceutical company NanoBio Corporation has changed its name to BlueWillow Biologics, which the company says “reflects its evolution to a vaccines-focused company, and commitment to advancing its novel intranasal technology to develop new vaccines… Read more . . .
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Janssen Pharmaceutical has announced that data from a Phase 3 study demonstrated significantly significant and clinically meaningful reduction of symptoms in adult patients with treatment-resistant depression who received esketamine nasal spray plus an oral antidepressant… Read more . . .
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Engage Therapeutics has announced the initiation of the double-blind, randomized Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of inhaled alprazolam in epilepsy patients who have seizures with a predictable pattern. The company said… Read more . . .
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Approximately 550 OINDP specialists attended RDD 2018 in Tucson, Arizona, where much of the interest centered around regulatory issues, especially in light of the FDA’s recent release of a revised draft guidance on MDI and… Read more . . .
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Leading diabetes research funder JDRF has awarded a 2-year $525,000 grant to International Diabetes Center (IDC) to support a study of intranasal insulin in Type 1 diabetes patients with hypoglycemia unawareness, the first time that… Read more . . .
Featured event:
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5th Annual Inhaled & Nasal Biologics | DNA Forum
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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