The National Institutes of Health said this week that it is funding 4 projects dedicated to testing fully automated artificial pancreas devices in patients with Type I diabetes. The race to develop an artificial pancreas met a milestone last year, after the FDA approved Medtronic’s (NYSE:MDT) hybrid model of an artificial pancreas – the 1st of its kind […]
Drug-Device Combinations
FDA accepts Intarcia’s NDA for diabetes drug-device combo
Intarcia Therapeutics said today that the FDA accepted its New Drug Application for the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The Medici drug-device combo delivers exenatide subcutaneously using a match-sized osmotic pump placed under the skin in an in-office procedure. The subcutaneous delivery system uses technology to stabilize proteins, peptides, antibody fragments […]
Pulmatrix raises $3m in direct offering
Pulmatrix (NSDQ:PULM) said today that unnamed institutional investors agreed to purchase approximately $3.3 million of shares of common stock in a direct offering. The company said it plans to sell 950,000 shares at $3.50 apiece. Pulmatrix expects the offering, which will close next week, to bring in $3.0 million in proceeds to use for general […]
Braeburn pulls the plug on $150m IPO, citing market conditions
Braeburn Pharmaceuticals pulled its plans for a $150 million initial public offering yesterday, citing unstable market conditions. The Princeton, N.J.-based company 1st announced plans to go public in late December and in mid-January, Braeburn said it planned to raise $150 million by offering 7,692,308 shares of its common stock at $18.00 to $21.00 apiece. The company […]
Mylan hit with antitrust lawsuit over EpiPen device
Mylan (NSDQ:MYL) said on Monday that it is undergoing an antitrust probe by the Federal Trade Commission into the company’s commercial practices regarding its EpiPen device. The Canonsburg, Pa.-based company reportedly responded to the allegations that it improperly fought off competition, saying “any suggestion that Mylan took any inappropriate or unlawful actions to prevent generic competition […]
FDA OKs Medtronic trial for In.Pact Admiral DCB in renal disease
Medtronic (NYSE:MDT) said today that the FDA approved its investigational device exemption application for a study to evaluate its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The Fridley, Minn.-based company said that its study will compare its DCB to plain balloon angioplasty as a treatment for failing arteriovenous fistulas. The primary efficacy endpoint […]
Vectura wins IND for drug-device combo for pediatric asthma
Vectura said yesterday that the FDA approved an Investigational New Device application for its drug-device combination to treat asthma in children 12 months to 8 years old. The UK-based company’s device, VR647, uses the Akita Jet nebulizer for the delivery of nebulized budesonide. Vectura’s drug-device combination product provides faster delivery time and better lung deposition of budesonide, […]
Medtronic touts In.Pact Admiral drug-coated balloon data
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon in patients with peripheral arterial disease. The company presented outcomes from its In.Pact Global study patient cohorts in Asia and Belgium, concluding that its DCB demonstrated consistent outcomes across patient populations. More than 96% of the 114-patient study group in Asia achieved positive outcomes, which […]
Trelleborg features engineered coating fabrics, contract manufacturing services for combo products
Trelleborg plans to be on site at MD&M West 2017, a medical technology conference in California next month, highlighting its portfolio of engineered coated fabrics for medical, orthopedic and surgical applications, as well as the company’s contract manufacturing services for drug-device combination products. Trelleborg Engineered Coated Fabrics develops polyurethane, rubber and silicone-coated fabrics for devices such […]
Ocular Therapeutix resubmits NDA for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval for the […]