Medical

On a form 8-k filed with the US Securities and Exchange Commission (SEC), United Therapeutics reported the following: "On September 20, 2022, United Therapeutics Corporation (the Company) announced the termination of the PERFECT clinical study evaluating Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with chronic … [Read more...] about United Therapeutics stops Phase 3 PERFECT trial of Tyvaso inhalation solution in PH-COPD patients

Synairgen announced that it will present data from the Phase 3 SPRINTER trial of its SNG001 nebulized interferon-beta-1a in hospitalized COVID-19 patients at an upcoming meeting showing that treatment with SNG001 reduced symptoms of long COVID at 60 and 90 days post treatment compared to placebo. According to the data provided, patients treated with SNG001 had a 28.3% … [Read more...] about Synairgen to present data showing its SNG001 nebulized interferon-beta-1a may reduce the risk of long COVID symptoms

Satsuma Pharmaceuticals announced that data from a portion of the Phase 3 ASCEND trial of the company's STS101 dihydroergotamine (DHE) nasal powder where STS101 was delivered via a second generation device for the treatment of migraine did not reveal any significant safety concerns. Satsuma also said that efficacy was improved when subjects used the new device … [Read more...] about Satsuma announces data from the Phase 3 ASCEND trial of STS101 DHE migraine using second generation nasal delivery device

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

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

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

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 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