Revelation Biosciences announced that the Phase 1b CLEAR challenge study of its REVTx-99b intranasal phosphorylated hexaacylated disaccharide (PHAD) in participants with allergies to rye grass pollen showed that the nasal drops were safe and well tolerated but failed to demonstrate any reduction of allergy symptoms or improvement in breathing. The company said that, … [Read more...] about Phase 1b challenge study of Revelation’s REVTx-99b nasal spray fails to meet efficacy endpoints
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ARS to merge with Silverback to support development and commercialization of Neffy epinephrine nasal spray
ARS Pharmaceuticals plans to merge with Silverback Therapeutics, the companies said, with the combined company focused on approval and launch of ARS's Neffy (ARS-1) epinephrine nasal spray for the treatment of allergic reactions. Shareholders of Silverback, whose pipeline consists of a therapy for the treatment of chronic hepatitis B in early development, will own a … [Read more...] about ARS to merge with Silverback to support development and commercialization of Neffy epinephrine nasal spray
Phase 3 trial of VistaGen’s PH94B nasal spray for social anxiety disorder fails to meet primary endpoint
VistaGen Therapeutics said that the PALISADE-1 Phase 3 clinical trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder failed to meet its primary endpoint. The company announced the initiation of the PALISADE-1 trial in May 2021, and a second Phase 3 trial, PALISADE-2, got underway in September 2021. According to VistaGen, "the … [Read more...] about Phase 3 trial of VistaGen’s PH94B nasal spray for social anxiety disorder fails to meet primary endpoint
Phase 1 trial of Blue Lake’s BLB-201 intranasal vaccine for RSV gets underway
CyanVac subsidiary Blue Lake Biotechnology said that dosing has begun in a Phase 1 clinical trial of the company's BLB-201 intranasal vaccine against respiratory syncytial virus. The open label trial is expected to enroll 15 healthy adults aged 18 to 59 and 15 adults aged 60 to 75 who will each receive a single intranasal dose of BLB-201. The company had announced … [Read more...] about Phase 1 trial of Blue Lake’s BLB-201 intranasal vaccine for RSV gets underway
Proveris Scientific announces the hire of Alyssa Rubino as Technical Data Scientist
OINDP characterization specialist Proveris Scientific announced that former Proveris Associate Product Manager Alyssa Rubino has rejoined the company as a Technical Data Scientist at Proveris Laboratories. Rubino, who was most recently Medical and Dental Product Manager at Tekscan, had originally joined Proveris as a Product Applications Engineer in 2014. … [Read more...] about Proveris Scientific announces the hire of Alyssa Rubino as Technical Data Scientist
SoftOx gets funding from European Defense Fund to develop inhalation solution as a military countermeasure
SoftOx Solutions has announced that the European Defense Fund has awarded a 3-year grant of approximately NOK 97 million (~€9.6 million) to the company's subsidiary SoftOx Defense Solutions (SDS) for development of an inhalation solution as a part of a project developing countermeasures against harm from chemical, biologic, radioactive, and nuclear (CBRN) substances. … [Read more...] about SoftOx gets funding from European Defense Fund to develop inhalation solution as a military countermeasure
PTAB rules in Liquidia’s favor, finds another Tyvaso patent’s claims are not patentable
According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has found that none of the claims included in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are valid. The company said that the PTAB ruling would have to be upheld on appeal before it can affect a court ruling holding up final approval of Liquidia's NDA for … [Read more...] about PTAB rules in Liquidia’s favor, finds another Tyvaso patent’s claims are not patentable
Impel initiates Phase 2a study of INP105 intranasal olanzapine in autistic adolescents
Impel Pharmaceuticals said that it has initiated a Phase 2a study of its INP105 intranasal olanzapine in adolescents with autism spectrum disorder, with results expected early next year. In January 2019, Impel (then Impel Neuropharma) announced positive Phase 1 results for INP105, which it was developing at the time for the treatment of acute agitation in bipolar I … [Read more...] about Impel initiates Phase 2a study of INP105 intranasal olanzapine in autistic adolescents
Study finds fluticasone furoate DPI ineffective for the treatment of COVID-19
According to researchers from the Duke Clinical Research Institute (DCRI) and Vanderbilt University, the ACTIV-6 study of repurposed medicines for the treatment of mild-to-moderate COVID-19 has found that inhaled dry powder fluticasone furoate provided no benefit compared to inhaled placebo. Results have been published on medRxiv in an article titled "Inhaled … [Read more...] about Study finds fluticasone furoate DPI ineffective for the treatment of COVID-19
Odyssey Health says PRV-002 nasal spray safe and well tolerated in Phase 1 SAD trial
Odyssey Health said that a Phase 1 single ascending dose trial of PRV-002 nasal spray, which it describes as "a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion)," has been completed. According to Odyssey, the trial found a linear dose response, and all dose levels were safe and well tolerated. In addition to … [Read more...] about Odyssey Health says PRV-002 nasal spray safe and well tolerated in Phase 1 SAD trial