Bryn Pharma said that it has completed a pivotal study of its Utuly (BRYN-NDS1C) epinephrine nasal spray comparing PK/PD profiles of Utuly to a 0.3 mg dose of epinephrine delivered by autoinjector. According to the company's web site, Bryn is pursuing the 505(b)(2) NDA pathway with Mylan's EpiPen as the reference listed drug. In 2020, Bryn announced that it had raised … [Read more...] about Bryn Pharma says results from a pivotal study of Utuly epinephrine nasal spray are encouraging
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Nemera opens new headquarters
Device maker Nemera has announced the opening of its new headquarters building in Lyons, France. According to the company, the new BREEAM-certified building will also be home to the company's European innovation teams. Nemera also has an innovation center located in the US. The company develops and manufactures a wide range of OINDPs, including nasal spray pumps, … [Read more...] about Nemera opens new headquarters
China okays emergency use of CanSinoBio’s Convidecia Air inhaled COVID-19 vaccine
According to CanSino Biologics, China's National Medical Products Administration (NMPA) has approved the company's Convidecia Air nebulized COVID-19 vaccine as a booster dose. In December 2021, CanSino Bio announced a deal with Aerogen for the use of Aerogen vibrating mesh nebulizers for delivery of the adenovirus vector vaccine. … [Read more...] about China okays emergency use of CanSinoBio’s Convidecia Air inhaled COVID-19 vaccine
Vistagen to continue Phase 3 PALISADE-2 trial of PH94B nasal spray
Vistagen Therapeutics has announced that it will restart the Phase 3 PALISADE-2 trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder (SAD), which the company had paused after the PALISADE-1 trial failed to meet its primary endpoint. According to Vistagen, an independent interim analysis of unblinded data from 140 subjects from … [Read more...] about Vistagen to continue Phase 3 PALISADE-2 trial of PH94B nasal spray
India clears Bharat Biotech’s iNCOVACC intranasal COVID-19 vaccine for emergency use
According to Bharat Biotech, Indian regulators have cleared its iNCOVACC (BBV154) intranasal vaccine against COVID-19 for use in adults aged 18 and older under a Restricted Use in Emergency Situation. Following the approval, Bharat Bio said, "the product will be launched and available for use in due course of time." Bharat Bio announced in September 2020 that it … [Read more...] about India clears Bharat Biotech’s iNCOVACC intranasal COVID-19 vaccine for emergency use
FluGen announces progress in age de-escalating trial of M2SR intranasal flu vaccine in children
FluGen has announced that a Phase 1b age de-escalation clinical trial of its M2SR intranasal live virus flu vaccine has completed enrollment of the first cohort, which includes children aged 9-17. The study will subsequently evaluate the monovalent Singapore 2016 H3N2 M2SR influenza A vaccine in a cohort of children aged 2-8 and then in children aged 6-23 months, with … [Read more...] about FluGen announces progress in age de-escalating trial of M2SR intranasal flu vaccine in children
Iliad Biotechnology raises $42.8 million for Phase 2b study of BPZE1 intranasal pertussis vaccine
Illiad Biotechnologies has closed a $42.8 million financing round, the company said, with the funds intended to support a Phase 2b challenge study of the company's BPZE1 intranasal pertussis vaccine as well as other development and manufacturing activities. The company said that the new funding brings the total for development of BPZE1 to more than $100 … [Read more...] about Iliad Biotechnology raises $42.8 million for Phase 2b study of BPZE1 intranasal pertussis vaccine
PADAC schedules meeting to discuss Avillion’s NDA for PT027 albuterol / budesonide MDI
The FDA has published notice of an online meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to take place on November 8, 2022 for the purpose of discussing Avillion and AstraZeneca's NDA (214070) for PT027 albuterol / budesonide MDI for the treatment of asthma in patients aged 4 and older. The agency accepted the NDA in May 2022. According to the … [Read more...] about PADAC schedules meeting to discuss Avillion’s NDA for PT027 albuterol / budesonide MDI
Positive Phase 1 results for MannKind’s clofazimine inhalation suspension
MannKind Corporation announced today that a Phase 1 study of MNKD-101 clofazimine demonstrated that the inhalation suspension was well tolerated at doses up to 90 mg/day over 7 days and identified no safety issues. The company is developing MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung disease. According to MannKind, the FDA has granted both … [Read more...] about Positive Phase 1 results for MannKind’s clofazimine inhalation suspension
Hoth Therapeutics says that its HT-004 inhaled antisense oligonucleotide reduced lung inflammation in a mouse model
Hoth Therapeutics said that a preclinical study conducted at North Carolina State University demonstrated that the company's HT-004 inhaled antisense oligonucleotide significantly reduced lung inflammation in mice following an ovalalbumin challenge. According to Hoth, HT-004 works "to eliminate cell surface high-affinity IgE receptor (FceRI) expression and function on … [Read more...] about Hoth Therapeutics says that its HT-004 inhaled antisense oligonucleotide reduced lung inflammation in a mouse model