The FDA has cleared BlueWillow Biologics' IND for its BW-1010 intranasal anthrax vaccine, and a Phase 1 trial of the vaccine is planned for later this year, the company said. Earlier this year, BlueWillow (formerly NanoBio) announced that it had received a patent for the anthrax vaccine, which is formulated with the company's NanoVax adjuvant. BW-1010 is in … [Read more...] about FDA clears BlueWillow IND for intranasal anthrax vaccine
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Seelos Therapeutics says it has amended agreement for development of its intranasal ketamine
Seelos Therapeutics has announced an amendment of its agreement with Vyera Pharmaceuticals regarding development of SLS-002 intranasal ketamine. According to Seelos, the company will now not be required to conduct a Phase 3 trial and will make cash and stock payments to Vyera instead of a milestone that would be due on initiation of a Phase 3 trial. Seelos said … [Read more...] about Seelos Therapeutics says it has amended agreement for development of its intranasal ketamine
HCmed introduces Pulmogine nebulizer
HCmed Innovations has introduced its new Pulmogine mesh nebulizer, which is capable of delivering a variety of drugs for inhalation, including biologics and high viscosity solutions. The nebulizer is customizable for specific formulations, and the company says that it can effectively deliver drugs such as dornase alfa, colistin, and tobramycin for the treatment of … [Read more...] about HCmed introduces Pulmogine nebulizer
Aradigm says Linhaliq likely to receive negative opinion from CHMP
According to Aradigm Corporation, the company has been informed that its MAA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE) is likely to receive a negative opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). CHMP is scheduled to … [Read more...] about Aradigm says Linhaliq likely to receive negative opinion from CHMP
Bryn Pharma to use Aptar’s Bidose nasal device for epinephrine delivery
Bryn Pharma (formerly Epi-Now) announced that it has signed a deal with Aptar Pharma for worldwide exclusive rights to use Aptar's Bidose nasal delivery device for its BRYN-NDS1C intranasal epinephrine for the treatment of anaphylaxis. The company said that it has recently completed dosing in a pivotal clinical trial using the device. According to Bryn's website, … [Read more...] about Bryn Pharma to use Aptar’s Bidose nasal device for epinephrine delivery
Circassia announces US launch of Duaklir Pressair for the treatment of COPD
Circassia Pharmaceuticals has announced the US launch of Duaklir aclidinium bromide/formoterol fumarate DPI for the treatment of COPD. The FDA approved Duaklir Pressair in April 2019. Circassia acquired the US rights to Duaklir and Tudorza Pressair from AstraZeneca in 2017. Circassia Chief Executive Steve Harris commented, “The US launch of Duaklir represents a … [Read more...] about Circassia announces US launch of Duaklir Pressair for the treatment of COPD
AZTherapies raises $26.3 million in Series C financing
AZTherapies said that the company had closed a $26.3 million Series C preferred equity financing round that will fund completion of a Phase 3 trial of its ALZT-OP1 inhaled cromolyn/oral ibuprofen for the treatment of Alzheimer's disease. The COGNITE study was initiated in 2015 and is expected to be completed by the end of 2020. The company said that proceeds from … [Read more...] about AZTherapies raises $26.3 million in Series C financing
Janssen’s Spravato esketamine nasal spray gets positive opinion from CHMP
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Janssen's Spravato esketamine nasal spray for use with either a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) for the treatment of treatment-resistant major depressive disorder, the company said. A final decision by the … [Read more...] about Janssen’s Spravato esketamine nasal spray gets positive opinion from CHMP
DDL2019 to celebrate 30 years of Drug Delivery to the Lungs
The 2019 iteration of the Drug Delivery to the Lungs conference, which will take place December 11-13, marks the event's 30th year and will be the 15th DDL meeting held at the Edinburgh International Conference Centre. From its initial 1989 gathering of 100 delegates at the GlaxoSmithKline site in Ware, UK, the meeting has grown significantly, drawing over 850 … [Read more...] about DDL2019 to celebrate 30 years of Drug Delivery to the Lungs
Boehringer Ingelheim initiates Phase 2 trial of inhaled ENaC inhibitor for CF
Boehringer Ingelheim has announced the initiation of a Phase 2 clinical trial of its BI 1265162 inhaled epithelial sodium channel (ENaC) inhibitor delivered via the Respimat SMI plus standard of care in cystic fibrosis patients. The study is expected to enroll 98 patients aged 12 and over and will compare twice daily doses of BI 1265162 inhalation solution to … [Read more...] about Boehringer Ingelheim initiates Phase 2 trial of inhaled ENaC inhibitor for CF