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
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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
Positive Phase 2 results for Pulmotect’s PUL-042 inhaled immunostimulant against COVID-19
Pulmotect has announced topline results from one of two Phase 2 trials of its PUL-042 immunostimulant inhalation solution demonstrating that PUL-042 therapy significantly reduced the time to respiratory symptom improvement in early-stage COVID-19 patients. The company announced its plans to initiate the two trials in May 2020 and later announced that the US Department … [Read more...] about Positive Phase 2 results for Pulmotect’s PUL-042 inhaled immunostimulant against COVID-19
COPD Foundation partners with Renovion for development of inhaled mucolytic
The COPD Foundation has partnered with Renovion on development of Renovion's ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the treatment of COPD and non-cystic fibrosis bronchiectasis, the foundation said. ARINA-1, which is delivered via the PARI eFlow nebulizer system, received orphan drug designation from the FDA for the treatment of lung … [Read more...] about COPD Foundation partners with Renovion for development of inhaled mucolytic
Phase 2 trial of inhaled Ampion for COVID-19 gets approval from Indian authorities
According to Ampio Pharmaceuticals, the Drugs Controller General of India (DCGI) has approved the protocol for AP-019 Phase 2 trial of the company's inhaled Ampion biologic for the treatment of respiratory distress caused by COVID-19. Ampio announced in June 2021 that it had initiated the Phase 2 AP-019 clinical trial in the US and noted that the FDA had approved … [Read more...] about Phase 2 trial of inhaled Ampion for COVID-19 gets approval from Indian authorities
GSK says it is evaluating new MDI propellant as part of commitment to reducing greenhouse gas emissions
GlaxoSmithKline has announced an initiative to evaluate a new lower global warming potential propellant for its metered dose inhalers as part of an effort to reach net zero carbon emissions. According to GSK, its Ventolin albuterol (salbutamol) MDIs for the rescue treatment of asthma account for 45% of the company's current carbon emissions, and the company expects … [Read more...] about GSK says it is evaluating new MDI propellant as part of commitment to reducing greenhouse gas emissions