Otitopic has announced that a Phase 1 trial of its Asprihale dry powder aspirin found that the inhaled formulation demonstrated antithrombotic effects at 2 minutes post dose compared to 30 minutes post dose for a 162 mg chewable aspirin tablet. Both the inhaled and chewable aspirin maintained maximum antithrombotic effects at 24 hours post dose. In February 2019, … [Read more...] about Otitopic announces results from Phase 1 trial of its inhaled aspirin
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TFF initiates Phase 1 trial of inhaled voriconazole
TFF Pharmaceuticals has announced the initiation of Phase 1 trial of its dry powder voriconazole, which the company is developing for the treatment of invasive pulmonary aspergillosis (IPA). The Phase I SAD/MAD study will be conducted in Canada and will enroll a total of 64 healthy subjects, 32 in each part. The company recently raised $22 million in an initial … [Read more...] about TFF initiates Phase 1 trial of inhaled voriconazole
Insmed appoints Martina Flammer as Chief Medical Officer, provides update on Arikayce
Insmed has announced the appointment of Martina Flammer as Chief Medical Officer, effective mid-December 2019. Flammer was most recently Senior VP Customer Value at Boehringer Ingelheim and her previous positions include VP Medicine, Regulatory Affairs & Pharmacovigilance at BI Canada; VP Clinical Development & Medical Affairs of BI's Specialty Care Business … [Read more...] about Insmed appoints Martina Flammer as Chief Medical Officer, provides update on Arikayce
Studies show Penthrox is superior to standard of care for acute trauma pain
Medical Developments International (MDI) has announced data from multiple European studies demonstrating the benefits of MDI's Penthrox methoxyflurane inhaler for the treatment of pain from acute trauma. Among the findings announced, Penthrox was shown to be superior to intravenous morphine, NSAIDS, paracetamol (acetaminophen), and ketoprofen in trauma settings; … [Read more...] about Studies show Penthrox is superior to standard of care for acute trauma pain
Boehringer Ingelheim initiates Phase 2 trial of inhaled ENaC inhibitor for CF
Boehringer Ingelheim has announced the initiation of a Phase 2 clinical trial of its BI 1265162 inhaled epithelial sodium channel (ENaC) inhibitor delivered via the Respimat SMI plus standard of care in cystic fibrosis patients. The study is expected to enroll 98 patients aged 12 and over and will compare twice daily doses of BI 1265162 inhalation solution to … [Read more...] about Boehringer Ingelheim initiates Phase 2 trial of inhaled ENaC inhibitor for CF
Milestone Pharmaceuticals initiates Phase 3 safety study of intranasal etripamil for PVST
Milestone Pharmaceuticals has announced the initiation of the Phase 3 NODE-303 open-label safety study of the company's intranasal etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). NODE-303 is the third of three trials in the Phase 3 program for etripamil. NODE-301 was initiated in August 2018, and NODE-302 got underway in December 2018. … [Read more...] about Milestone Pharmaceuticals initiates Phase 3 safety study of intranasal etripamil for PVST
Chiesi reports positive results from Phase 3 studies of extrafine triple combination MDI
Chiesi Farmaceutici has announced results from the Phase 3 TRIGGER and TRIMARAN studies of its CHF 5993 extrafine beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium (G) MDI for the treatment of uncontrolled asthma in patients who have had at least one exacerbation in the past year. CHF 5993, also known as Riarify, contains the same three drugs as … [Read more...] about Chiesi reports positive results from Phase 3 studies of extrafine triple combination MDI
Novartis reports positive results from Phase 3 study of QMF149 for asthma
Novartis has announced that its Phase 3 PALLADIUM trial of QMF149 indacaterol acetate/mometasone furoate (IND/MF) delivered via the Breezhaler DPI in patients with uncontrolled asthma met its primary endpoint, demonstrating superior improvement in lung function after 26 weeks compared to mometasone furoate alone. The company said that its MAA for QMF149 has been … [Read more...] about Novartis reports positive results from Phase 3 study of QMF149 for asthma
Noveome initiates Phase 1 safety trial of intranasal biologic for delivery to the optic nerve
Noveome Biotherapeutics said that it has initiated a Phase 1 safety trial of its ST266 secretome delivered intranasally in patients with intraocular hypertension. The study will use a device from SipNose designed to deliver drugs across the blood-brain barrier to deliver ST266. Noveome is developing ST266 in several dosage forms, with intranasal ST266 also in … [Read more...] about Noveome initiates Phase 1 safety trial of intranasal biologic for delivery to the optic nerve
Santhera publishes data from Phase 1 study of its inhaled hNE inhibitor
Santhera Pharmaceuticals has announced the publication of data from two Phase 1 studies of its POL6014 inhaled human neutrophil elastase (hNE) inhibitor in the Journal of Cystic Fibrosis. According to the company, inhalation of nebulized POL6014 resulted in a rapid reduction of hNE in the sputum of cystic fibrosis patients, with high lung concentrations of POL6014 … [Read more...] about Santhera publishes data from Phase 1 study of its inhaled hNE inhibitor