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 drug and QIDP designation to MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung infections. The company also announced the … [Read more...] about MannKind says it will advance MNKD-101 clofazimine inhalation suspension to Phase 2/3 study
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FDA accepts Opiant’s NDA for OPNT003 intranasal nalmefene
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 October 2022, Opiant announced that it had completed its rolling submission of the NDA for OPNT003. The company has received funding from the … [Read more...] about FDA accepts Opiant’s NDA for OPNT003 intranasal nalmefene
Pulmobiotics publishes data from pre-clinical studies of its live biotherapeutic for the treatment of P. aeruginosa lung infections
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. According to Pulmobiotics, inoculation with the modified Mycoplasma pneumoniae doubled the survival … [Read more...] about Pulmobiotics publishes data from pre-clinical studies of its live biotherapeutic for the treatment of P. aeruginosa lung infections
Medical Developments International discontinues planned clinical trials of Penthrox methoxyflurane inhaler in China
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 and consequently the commercial launch of Penthrox in the market, primarily due to the challenging regulatory environment and … [Read more...] about Medical Developments International discontinues planned clinical trials of Penthrox methoxyflurane inhaler in China
Vero Biotech closes $30 million financing to support commercialization of Genosyl tankless iNO system
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 received FDA approval for the third generation Genosyl DS for delivery of iNO to increase oxygenation in newborn infants with … [Read more...] about Vero Biotech closes $30 million financing to support commercialization of Genosyl tankless iNO system
Cyrano announces plans for Phase 2 trial of CYR-064 intranasal theophylline in patients with post-viral hyposmia
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 of smell) following a viral infection. In December 2020, Cyrano announced that it had raised $12.8 million for a Phase 2 trial of CYR-064. The six-month trial … [Read more...] about Cyrano announces plans for Phase 2 trial of CYR-064 intranasal theophylline in patients with post-viral hyposmia
Adherium gets almost £500,000 from SBRI Healthcare for inhaler monitoring project
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 enabled asthma management in high-risk children aged 5 to 16 years managed in primary care to prevent asthma attacks," will … [Read more...] about Adherium gets almost £500,000 from SBRI Healthcare for inhaler monitoring project
Krystal Biotech’s KB407 inhaled gene therapy for CF gets EC orphan designation
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 the lungs via nebulization, also has received Orphan Drug designation from the FDA. In August 2022, Krystal announced plans … [Read more...] about Krystal Biotech’s KB407 inhaled gene therapy for CF gets EC orphan designation
Isterian Biotech to develop inhaled TG2 inhibitor for the treatment of IPF
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) inhibitor that has been shown to reduce lung fibrosis in a mouse model and which Isterian intends to develop as an inhaled … [Read more...] about Isterian Biotech to develop inhaled TG2 inhibitor for the treatment of IPF
FDA approves Avillion and AstraZeneca’s Airsupra (PT027) albuterol / budesonide MDI for the treatment of asthma
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 May 2022, the FDA accepted Avillion's NDA for Airsupra. The NDA sought approval for the inhaler's use as an asthma therapy by … [Read more...] about FDA approves Avillion and AstraZeneca’s Airsupra (PT027) albuterol / budesonide MDI for the treatment of asthma