Aptar Pharma announced that it has launched a metal-free multidose nasal spray pump called APF Futurity for delivery of over-the-counter formulations. According to Aptar Pharma, APF Futurity is designed to be recyclable without removing the pump from a container bottle and has received Class AA certification from cyclos-HT. Aptar Product Sustainability Director … [Read more...] about Aptar Pharma launches APF Futurity metal-free nasal spray pump for OTC products
News
Berry to open new manufacturing facility in Bangalore, India
Device manufacturer Berry Global says that it intends to hire 500 employees over 8 years to staff its new manufacturing facility in Bangalore, India, which will produce a variety of products, including nasal and inhaled drug delivery devices. The company had announced plans for the site in August 2021. Berry says that the Bangalore site has received International … [Read more...] about Berry to open new manufacturing facility in Bangalore, India
Bharat Biotech launches iNCOVACC intranasal COVID-19 vaccine in India
Bharat Biotech has announced the launch of its iNCOVACC (BBV154) intranasal COVID vaccine in India for use as both primary series and booster. In September 2022, India's Central Drugs Standard Control Organization (CDSCO) approved the use of iNCOVACC in adults aged 18 and older. iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine that Bharat … [Read more...] about Bharat Biotech launches iNCOVACC intranasal COVID-19 vaccine in India
Vistagen initiates Phase 1 trial of PH10 pherine nasal spray
Vistagen has announced the initiation of a Phase 1 clinical trial of its PH10 pherine nasal spray, which the company is developing for the treatment of major depressive disorder. In November 2022, the company announced that it had gotten the go-ahead for the Phase 1 trial of a new formulation of PH10 from the FDA, and the agency granted Fast Track designation to PH10 … [Read more...] about Vistagen initiates Phase 1 trial of PH10 pherine nasal spray
MannKind says it will advance MNKD-101 clofazimine inhalation suspension to Phase 2/3 study
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
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