Aradigm Corp. (NSDQ:ARDM) said today that its inhaled antibiotic failed in a late-stage clinical trial, sending the Hayward, Calif.-based company’s stock down -54% in premarket trading. Pulmaquin is a once-daily formulation containing ciprofloxacin, a widely prescribed broad-spectrum antibiotic. The inhaled drug was being tested to treat patients with non-cystic fibrosis bronchiectasis (non-CF BE) who have chronic […]
Clinical Trials
Nordisk touts Tresiba insulin injection data
Novo Nordisk (NYSE:NVO) said today that data from the Devote clinical trial indicated that its injected insulin, Tresiba, reduced the risk of severe hypoglycemia when compared to insulin glargine. The trial enrolled more than 7,500 type 2 diabetes patients at high risk of adverse cardiovascular events and treated them for 2 years with either Tresiba or insulin glargine […]
OCUL registers for $40m stock sale
Ocular Therapeutix (NSDQ:OCUL) is looking to raise $40 million through a public stock offering, according to a prospectus filed with the federal Securities & Exchange Commission this week. The Bedford, Mass.-based company said it inked a controlled equity offering sales agreement with Cantor Fitzgerald & Co., and agreed to pay Cantor Fitzgerald commissions of up to 3% […]
Oramed touts phase Ib data for type 2 diabetes capsule
Oramed Pharmaceuticals (NSDQ:ORMP) said today that it finished a phase Ib study of its oral GLP-1 analog capsule for type 2 diabetes. Glucagon-like peptide-1 (GLP-1) is a hormone that stimulates the pancreas to secrete insulin. Exenatide, a GLP-1 analog, is available on the market as an injection for patients with type 2 diabetes. The analog […]
Windtree touts inhaled therapy for infants with respiratory distress syndrome
Windtree Therapeutics (NSDQ:WINT) today released data from a phase IIa trial evaluating its inhaled Aerosurf lucinactant designed for premature infants with respiratory distress syndrome. Results from the trial were presented at the 6th International Congress of European Neonatal and Perinatal Societies in Valencia, Spain. Premature babies often lack adequate surfactant – a naturally occurring substance that reduces the surface […]
Micell begins MiStent clinical trial in Japan
Micell Technologies said today that it began its Dessolve J randomized, double-blind study comparing its MiStent SES sirolimus eluting absorbable polymer coronary stent to the Xience V everolimus eluting coronary stent in patients with coronary artery disease. The Durham, N.C.-based company touts its device as a bare-metal stent coated in crystalline drug, sirolimus, and an absorbable polymer, […]
Galera adds $15m for Series B
Galera Therapeutics said today that it landed $15 million for its severe oral mucositis treatment, bringing its Series B financing total to $57 million. Sofinnova Ventures led the round, joining existing investors New Enterprise Associates, Novartis Venture Fund, Novo Ventures, Correlation Ventures, Enso Ventures and Galera Angels. The Malvern, Penn.-based company said the proceeds will be […]
Intec Pharma inks deal with Michael J. Fox Foundation for patient recruitment
Intec Pharma (NSDQ:NTEC) said today that it inked a deal with the Michael J. Fox Foundation for Parkinson’s Research to support the biopharmaceutical company’s patient recruitment and retention for its pivotal phase III trial. The study will evaluate Intec Pharma’s lead candidate, the “accordion pill” carbidopa/levodopa (AP-CD/LD), as a treatment for patients with advanced Parkinson’s […]
Immunovaccine’s targeted ovarian cancer therapy wins orphan drug status in EU
Immunovaccine Inc. said today that the European Medicines Agency granted orphan drug designation for its immunotherapy candidate for ovarian cancer in the EU. Orphan drug designation is granted to medicines intended for disease with a prevalence no greater than 5 in 10,000 people. According to the Nova Scotia-based company, ovarian cancer affects 3 per 10,000 […]
FDA clears Allergan’s Xen gel stent for glaucoma
Allergan (NYSE:AGN) said today that it won FDA approval for its Xen gel stent and injector for glaucoma. The federal watchdog indicated the drug device for the management of refractory glaucoma, in cases where surgical treatment has failed or in patients with open angle glaucoma that is unresponsive to maximum tolerated medical therapy. The Dublin-based […]
