GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not […]
Glooko wins FDA nod for mobile insulin dosing system
The FDA has approved Glooko‘s mobile insulin dosing system, which is designed to titrate long-acting insulin for people with Type II diabetes. The company’s system accesses blood glucose data directly from the user’s glucose meter so that the user doesn’t have to manually enter their fasting glucose values. Then, it analyzes those levels to recommend […]
Sandoz wins FDA nod for generic, injectable MS drug
Sandoz said today that the FDA has approved its Glatopa glatiramer acetate injection as a generic version of Copaxone to treat relapsing forms of multiple sclerosis. The therapy, which is given three days per week, is administered using the Glatopaject injection device. The 20 mg/mL version of the MS treatment has been available in the […]
Eylea wins approval in China for diabetic macular edema
Bayer (ETR:BAYN) said today that the Chinese State Food and Drug Administration has approved Eylea to treat patients who have visual impairment due to diabetic macular edema. It’s the first indication for Eylea to be approved by the Chinese regulatory body. The injectable eye drug is sold by Regeneron (NSDQ:REGN) in the U.S. and has been approved […]
Insulet’s closed-loop insulin delivery algorithm succeeds in feasibility study
The algorithm used in Insulet‘s (NSDQ:PODD) closed-loop insulin delivery system performed well in a 58-patient safety and feasibility study, according to a study published today in Diabetes Technology & Therapeutics. Insulet’s device, which is still in development, combines an insulin dosing algorithm, the OmniPod insulin patch pump and Dexcom‘s (NSDQ:DXCM) continuous glucose monitor into one system […]
Diabetes clinic taps DarioHealth for blood glucose monitoring tech
DarioHealth (NSDQ:DRIO) has partnered with the Diabetes and Endocrinology Consultants of Pennsylvania to bring its blood glucose monitoring system to the 5,000-patient facility. The company’s blood glucose monitor, which syncs with Dario’s diabetes management app, connects via a headphone jack to a mobile device, helping diabetes patients monitor their blood glucose throughout the day. The app also […]
NovaBay raises $6m in private placement
NovaBay Pharmaceuticals (NYSE:NBY) has raised nearly $6 million after selling 1.7 million shares of common stock to OP Financial Investments Ltd., an institutional investor listed on the Hong Kong stock exchange. The Emeryville, Calif.-based company is developing non-antibiotic products for the topical anti-infective market. Its Avenova product is designed for the removal of microorganisms and debris on […]
Delcath closes $5m offering
Delcath Systems (NSDQ:DCTH) has closed a $5 million offering of 212,000 shares of common stock, warrants to buy 38,000,000 shares of common stock and warrants to buy an aggregate of 500,000 shares of common stock. The New York-based company priced the offering at 2¢ per unit. Each unit was composed of one share of common stock […]
Pavmed floats exchange offer for discounted Series W shares
Pavmed Inc. (NSDQ:PAVM) today offered to trade a pair of its just-sold Series W warrants for a single Series Z unit worth $5.oo apiece. The New York-based company previously offered the opportunity for investors to exercise the Series W warrants at a discounted price of $2.00 per share. As of Feb. 8, Pavmed said 34,345 Series […]
Pulmatrix doses first patient in Ph1 Pulmazole trial
Pulmatrix (NSDQ:PULM) said today that the first patient was treated in a first-in-human study of Pulmazole – an inhaled formulation of the anti-fungal drug, itraconazole. The Lexington, Mass.-based company is evaluating its iSperse formulation of the drug as a treatment for asthma patients who have developed allergic bronchopulmonary aspergillosis. Patients with ABPA are usually given oral […]
