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
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Nanopharm and Fluidda team up to help inhaled drug developers pursue the alternative bioequivalence pathway
OINDP development specialist Nanopharm, which was acquired by Aptar Pharma in 2019, and functional respiratory imaging (FRI) company Fluidda are teaming up to help sponsors of ANDAs for inhaled drugs for asthma and COPD avoid the need for clinical end-point studies by pursuing the alternative bioequivalence pathway. Sponsors of 505(b)(2) NDAs for inhaled drugs and … [Read more...] about Nanopharm and Fluidda team up to help inhaled drug developers pursue the alternative bioequivalence pathway
MedPharm to provide development services for Mosanna’s MOS-118 potassium channel blocker nasal spray for sleep apnea
CDMO MedPharm has announced that it will provide formulation and delivery development services for Swiss startup Mosanna Therapeutics' MOS-118 potassium channel blocker, with the goal of advancing a nasal spray formulation into clinical development for the treatment of metabolic obstructive sleep apnea (MOSA). Mosanna was formed recently to develop MOS-118 (formerly … [Read more...] about MedPharm to provide development services for Mosanna’s MOS-118 potassium channel blocker nasal spray for sleep apnea
H&T Presspart partners with OzUK on MDI development services
Device maker H&T Presspart has partnered with CRO OzUK in order to offer complete development services for metered dose inhalers to H&T Presspart customers. OzUK, which specializes in MDIs and other liquid-based OINDPs, will provide formulation and testing services in conjunction with delivery device development services offered out of H&T Presspart's … [Read more...] about H&T Presspart partners with OzUK on MDI development services
Synairgen to present data showing its SNG001 nebulized interferon-beta-1a may reduce the risk of long COVID symptoms
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 announces data from the Phase 3 ASCEND trial of STS101 DHE migraine using second generation nasal delivery device
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
Startup Moat Biotechnology announces funding round, positive interim Phase 1 results for its intranasal COVID-19 vaccine
Startup Moat Biotechnology announced the initiation of a funding round led by Cortado Ventures that aims to raise up to $20 million for continued development of the company's intranasal vaccine against COVID-19. According to the announcement, Tetherex Pharmaceuticals has spun out MoatBio in order to develop single-cycle adenovirus vaccines based on SC-AdVax … [Read more...] about Startup Moat Biotechnology announces funding round, positive interim Phase 1 results for its intranasal COVID-19 vaccine
Akorn settles False Claims Act case involving continued sales of azelastine nasal spray as prescription-only after OTC conversion
The US Department of Justice has announced that Akorn will pay $7.9 million to settle a case related to submission of false claims to Medicare Part D after the company continued to sell three products, including azelastine nasal spray, as prescription drugs after conversion to over-the-counter. The allegations were initially made in a suit brought by a whistleblower … [Read more...] about Akorn settles False Claims Act case involving continued sales of azelastine nasal spray as prescription-only after OTC conversion
RIGImmune to develop intranasal stem-loop RNA therapeutics
Yale University spinout RIGImmune, which has been developing stemloop RNA (SLR) therapeutics, announced that it has acquired biotech Subintro, which has been working on antivirals for RNA virus-caused respiratory infections. The company will now develop intranasal therapeutics "that both activate the natural immune activation and demonstrate antiviral activity," … [Read more...] about RIGImmune to develop intranasal stem-loop RNA therapeutics
Copley Scientific launches EnviroMate environmental control chamber for OINDP testing
OINDP testing equipment maker Copley Scientific has announced the launch of the EnviroMate benchtop environmental control chamber, which is designed to reduce variability in OINDP testing that can occur due to inconsistent temperature, humidity, and electrostatic conditions. The chamber allows for DDU and APSD testing in a controlled environment without the need for a … [Read more...] about Copley Scientific launches EnviroMate environmental control chamber for OINDP testing