Calls for papers
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MannKind Corporation said that it will advance MNKD-101 clofazimine to a Phase 2/3 study following positive results from a Phase 1 trial of the inhalation suspension delivered via jet nebulizer. The FDA has granted both orphan… Read more . . .
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According to Opiant Pharmaceuticals, the FDA has accepted the company’s NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose for priority review and has set a PDUFA date of May 22, 2023. In… Read more . . .
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Spanish startup Pulmobiotics, a spinout from the Centre for Genomic Regulation (CRG), has published preclinical results in Nature Biotechnology demonstrating that the company’s live biotherapeutic reduced drug-resistant P. aeruginosa lung infections in a mouse model.… Read more . . .
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Medical Developments International (MVP) said that the company in no longer planning to conduct clinical trials of its Penthrox methoxyflurane inhaler in China due to “extended delays to the anticipated timeline for clinical trial outcomes… Read more . . .
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Vero Biotech announced an investment of $30 million from Petrichor Healthcare Capital Management that will be used for commercialization of Vero’s Genosyl DS tankless inhaled nitric oxide system. The company recently announced that it had… Read more . . .
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Cyrano Therapeutics said that the FDA has cleared the company’s IND and that Cyrano now plans to move ahead with a Phase trial of CYR-064 nasal soft mist theophylline in patients who experienced hyposmia (loss… Read more . . .
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Adherium announced that it received an award of £499,871 for an inhaler monitoring project from Small Business Research Initiative (SBRI) Healthcare, a program from the UK’s National Health Service. The project, titled “Smart Digital inhaler… Read more . . .
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According to Krystal Biotech, the European Commission has granted orphan designation to the company’s KB407 inhaled gene therapy for the treatment of cystic fibrosis. The company said that KB407, which delivers two copies of the CFTR gene to… Read more . . .
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Cambrian BioPharma announced that it has partnered with Aston University and Aston Professor Martin Griffin since 2019 on a startup called Isterian Biotech. According to the announcement, the company’s pipeline features a transglutaminase 2 (TG2)… Read more . . .
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According to Avillion and AstraZeneca, the FDA has approved Airsupra (PT027) albuterol / budesonide MDI for the treatment of asthma in adults. Avillion partnered with AstraZeneca subsidiary Pearl Therapeutics on development of PT027 in 2018. In… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA