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
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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
Kinaset initiates Phase 1b trial of its KN-002 dry powder JAK inhibitor
Kinaset Therapeutics said that dosing is underway in a Phase 1b SAD/MAD study of its KN-002 dry powder JAK inhibitor, which it is developing for the treatment of asthma and COPD. The trial is expected to enroll 48 healthy volunteers in the single ascending dose portion of the study and 32 asthma patients in the multiple ascending dose part of the study. The … [Read more...] about Kinaset initiates Phase 1b trial of its KN-002 dry powder JAK inhibitor
Theravance Biopharma restructures, will focus on respiratory drugs
Theravance Biopharma said that it expects to cut 270 jobs, or 75% of its current workforce, by February 2022 and that it will stop development of candidates outside of its respiratory portfolio. The announcement came just after the company announced the failure of a Phase 3 trial of its oral ampreloxetine. The company said that its R&D focus will now be on a label … [Read more...] about Theravance Biopharma restructures, will focus on respiratory drugs
VistaGen initiates second Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder
VistaGen Therapeutics said that it has initiated the PALISADE-2 Phase 3 clinical trial of its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). The company initiated the PALISADE-1 trial of PH94B for SAD in May 2021. Topline results from that trial are expected in mid-2022, with results from the PALISADE-2 trial expected later that … [Read more...] about VistaGen initiates second Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder
Adherium’s next generation Hailie inhaler sensor gets 510(k) clearance
According to Adherium, the company has received 510(k) clearance from the FDA for its next generation Hailie inhaler sensor. The new version of the Hailie sensor, which is meant to be used with the Symbicort MDI, includes the ability to capture clinical data in addition to inhaler usage data. Adherium says that the additional capability for monitoring asthma and COPD … [Read more...] about Adherium’s next generation Hailie inhaler sensor gets 510(k) clearance