Pulmodyne and Alcove Manufacturing and Distribution have announced a new partnership for manufacturing and distribution of Alcove's EZ-Spray intranasal mucosal atomization device and said that Pulmodyne is set to begin manufacturing and distributing EZ-Spray devices by the end of 2021. The two companies also said that they also intend to develop new atomization … [Read more...] about Pulmodyne partners with Alcove on manufacturing and distribution of the EZ-Spray atomization system
News
American Academy of Pediatrics highlights safety concerns related to the use of oxymetazoline nasal spray in pediatric surgery
The American Academy of Pediatrics (AAP) has issued a clinical report highlighting serious adverse events related to off-label use of OTC oxymetazoline nasal spray in children before and after surgery, noting that in these situations the drug "may be dosed without attention to the volume administered." The report cites recent cases of young children who suffered … [Read more...] about American Academy of Pediatrics highlights safety concerns related to the use of oxymetazoline nasal spray in pediatric surgery
Revelation Biosciences announces Phase 1b challenge study of its REVTx-99 intranasal PHAD for allergic rhinitis
According to Revelation Biosciences, the company has received clearance from an ethics committee for an Australian Phase 1b allergen challenge study of its REVTx-99 intranasal phosphorylated hexaacylated disaccharide (PHAD) for the treatment of allergic rhinitis and chronic nasal congestion. The trial, called RVL-CLR01, is expected to begin in the fourth quarter of … [Read more...] about Revelation Biosciences announces Phase 1b challenge study of its REVTx-99 intranasal PHAD for allergic rhinitis
Oncotelic Therapeutics to develop intranasal apomorphine
Oncotelic Therapeutics (formerly Mateon Therapeutics) announced that it has licensed an intranasal apomorphine formulation from Autotelic, Inc, a newly formed company owned largely by Oncotelic Chairman and CEO, Vuong Trieu. Oncotelic says that it plans to develop AL-101 nasal apomorphine for Parkinson's disease, erectile dysfunction, and female sexual dysfunction, … [Read more...] about Oncotelic Therapeutics to develop intranasal apomorphine
MannKind initiates Phase 3 trial of Afrezza inhaled insulin in pediatric patients
MannKind Corporation has announced the initiation of the INHALE-1 study of its Afrezza insulin DPI in type 1 and type 2 diabetes patients aged 4-17. The initial 26-week trial will evaluate Afrezza plus basal insulin versus multiple injections of insulin daily and is expected to enroll approximately 260 patients. Following that portion of the trial, all of the subjects … [Read more...] about MannKind initiates Phase 3 trial of Afrezza inhaled insulin in pediatric patients
Ryaltris nasal spray gets marketing approval in 13 countries in Europe, UK
Glenmark Pharmaceuticals said that its Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis has received final marketing approval in 13 countries in Europe and the UK. Earlier this year, the company announced that Ryaltris had received approval in 16 European countries and the UK through the decentralized … [Read more...] about Ryaltris nasal spray gets marketing approval in 13 countries in Europe, UK
BreatheSuite MDI monitoring system gets 510(k) clearance
BreatheSuite announced that the FDA has cleared the company's disposable BreatheSuite MDI device, which attaches to the top of a standard metered dose inhaler canister to provide inhaler usage monitoring and feedback to the patient and to health care providers through an associated mobile app. According to BreatheSuite, the device has also been cleared by Canadian … [Read more...] about BreatheSuite MDI monitoring system gets 510(k) clearance
CyanVac and Blue Lake Biotechnology initiate Phase 1 trial of CVXGA1 intranasal vaccine for COVID-19
Blue Lake Biotechnology and its parent company, University of Georgia spin off CyanVac, have announced the initiation of a Phase 1 trial of their CVXGA1 intranasal vaccine for the prevention of COVID-19. CVXGA1 is based on an attenuated strain of canine parainfluenza virus (PIV5). According to the two companies, the intranasal vaccine has demonstrated efficacy against … [Read more...] about CyanVac and Blue Lake Biotechnology initiate Phase 1 trial of CVXGA1 intranasal vaccine for COVID-19
Positive Phase 1 results for TFF’s inhaled tacrolimus
TFF Pharmaceuticals said that a Phase 1 SAD/MAD study of its tacrolimus inhalation powder, which the company is developing for the prevention of lung transplant rejection, demonstrated that the dry powder formulation can be dosed to achieve lung and blood concentrations of tacrolimus necessary for efficacy without causing kidney toxicity. Based on the Phase 1 results, … [Read more...] about Positive Phase 1 results for TFF’s inhaled tacrolimus
Codagenix says it plans to advance COVI-VAC nasal vaccine to Phase 2/3 based on positive Phase 1 topline results
According to Codagenix, a Phase 1 dose escalation trial of its COVI-VAC intranasal vaccine against COVID-19 in healthy adults has demonstrated "promising safety and immunogenicity results." Codagenix and Serum Institute of India initiated the Phase 1 trial in December 2020. Based on the Phase 1 data, the company said that it plans to advance COVI-VAC into Phase 2/3 … [Read more...] about Codagenix says it plans to advance COVI-VAC nasal vaccine to Phase 2/3 based on positive Phase 1 topline results