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
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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
Virpax to develop intranasal CBD for the treatment of epilepsy
Virpax says that it has acquired exclusive worldwide rights to Nanomerics's molecular envelope technology (MET) for use with Virpax's VRP324 intranasal dry powder cannabidiol (CBD) for the treatment of epilepsy. According to Virpax, Nanomerics is currently conducting preclinical studies of VRP324, which Virpax plans to develop for the treatment of seizures due to … [Read more...] about Virpax to develop intranasal CBD for the treatment of epilepsy
Neurelis initiates Phase 1/2a study of Valtoco nasal spray in pediatric epilepsy patients
Neurelis said that it has initiated the Stellina Phase 1/2a trial of Valtoco diazepam nasal spray in epilepsy patients between the ages of 2 and 5. The news comes almost exactly one year after the company announced plans for the pediatric trial and a future sNDA submission. Valtoco has been approved in the US for the treatment of seizure clusters in patients 6 years … [Read more...] about Neurelis initiates Phase 1/2a study of Valtoco nasal spray in pediatric epilepsy patients
DDL, BTS announce that they will cut ties with Vectura following PMI acquisition
The Drug Delivery to the Lungs conference organizing committee and the British Thoracic Society have both announced that they will cut ties with inhalation CDMO Vectura following the company's acquisition by tobacco company Philip Morris International. Vectura announced in May 2021 that it would be acquired by the Carlyle Group; however, the company withdrew its … [Read more...] about DDL, BTS announce that they will cut ties with Vectura following PMI acquisition
Pulmocide’s PC945 inhaled opelconazole gets orphan, Fast Track, and QIDP designations
Pulmocide announced that the FDA has granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations for its PC945 inhaled opelconazole for the treatment of invasive pulmonary aspergillosis (IPA). Pulmocide launched in 2013 to develop inhaled anti-fungal therapies, and PC945 is its sole product. According to the company's web site, nebulized … [Read more...] about Pulmocide’s PC945 inhaled opelconazole gets orphan, Fast Track, and QIDP designations
FDA and EMA launch parallel scientific advice pilot program for complex generic products
The EMA and the FDA have launched a pilot program in which the agencies will give parallel scientific advice (PSA) to applicants submitting MAAs for hybrid products and ANDAs for complex generic products, including inhalers and nasal sprays. The program began on September 15, 2021 and will continue to accept meeting requests "until a sufficient number of PSA meetings … [Read more...] about FDA and EMA launch parallel scientific advice pilot program for complex generic products
Intravacc to offer intranasal vaccine contract development services
Dutch vaccine developer Intravacc has announced that it will continue to develop its pipeline of intranasal vaccines while adding a contract development and manufacturing business. The company said that it will offer GMP manufacturing for clinical trials in addition to R&D services and expects to take on one or two contract projects per year. Intravacc's pipeline … [Read more...] about Intravacc to offer intranasal vaccine contract development services