Ivenix CEO Stuart Randle began his foray into drug pump delivery systems at Baxter in 1988, when he led the company’s effort to develop the 1st needle-free IV system. More than 20 years later, when he was approached about the corner office at Ivenix, Randle revisited the infusion pump industry and saw that the technology had not kept up […]
Drug-Device Combinations
GSK files for FDA approval of inhaled triple-combo therapy for COPD
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that GSK filed a regulatory submission with the FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. The triple-combo therapy includes 3 drugs: fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; vilanterol, a long-acting beta2-adrenergic agonist. The medicines […]
Artificial pancreas deemed safe for hospitalized patient use
U.K. researchers have reportedly demonstrated the safety and efficacy of the artificial pancreas in Type II diabetes patients in a general hospital ward. The team’s work was published in The Lancet Diabetes & Endocrinology. The closed-loop insulin delivery system can monitor blood sugar levels and change the insulin delivery rate accordingly, without the need for skin-pricks and […]
OrbusNeich launches Combo Plus stent
OrbusNeich said today that it launched the latest version of its dual-therapy stent, the Combo Plus, featuring an antibody biological coating designed to promote vessel healing in patients with complex coronary artery disease. After the stent is implanted, the biological coating captures endothelial progenitor cells and kicks off formation of an endothelial layer. A coating of bioabsorbable polymer […]
Intarcia seeks FDA nod for 1st drug to use Medici drug delivery system
Intarcia Therapeutics said today that it submitted a New Drug Application to the FDA for its injection-free ITCA 650 candidate, the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The ITCA 650 enables subcutaneous delivery of exenatide using a match-sized osmotic pump placed under the skin in an in-office procedure. With […]
DBV, BioNet-Asia study needle-free pertussis booster vaccination
DBV Technologies (NSDQ:DBVT) and BioNet-Asia said today that the independent Data & Safety Monitoring Board positively reviewed DBV’s needle-free vaccine patch technology, Viaskin, and that enrollment in a Phase I trial for booster immunization against pertussis will continue into the 2nd dosing cohort. The Viaskin pertussis booster vaccination program will test the ability of DBV’s needle-free vaccine […]
Delivra president & CFO resigns, names new finance VP | Personnel Moves, Nov. 17, 2016
Delivra Corp. (CVE:DVA) said today that president & CFO Chris Schnarr is resigning effective tomorrow and Pascal Attard has been promoted from controller to VP of finance. Attard has worked as controller for Red Tiger Mining Inc. and manager of McGovern, Hurley, Cunningham LLP prior to joining Delivera in 2015. The Toronto-based company said it is looking […]
Cumberland Pharma acquires U.S. rights to Nordic’s injectable methotrexate
Cumberland Pharmaceuticals (NSDQ:CPIX) said today that it acquired exclusive U.S. rights to Nordic Group‘s injectable methotrexate product line to treat rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis. Nordic Group has registered the product line for patient use in European countries, so Cumberland will register and commercialize the products in the U.S. […]
Cellnovo files 510(k) for connected diabetes management system
Cellnovo (EPA:CLNV) said today that it has filed for 510(k) clearance from the FDA for its diabetes management system. Paris-based Cellnovo touts its system as the 1st mobile, connected diabetes management system. Tubeless and compact, the company’s insulin pump has a mobile touchscreen controller with an integrated blood glucose meter. Data from insulin injections and blood-glucose levels are […]
Injectable opioid dependence treatment succeeds in clinical trial
Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals said this week that a late-stage trial of its injectable opioid dependence treatment was successful. CMAX shares surged 16% at the beginning of the week following the announcement. The injectable buprenorphine therapy could be another treatment used to combat the growing opioid epidemic in the United States, which claimed the lives […]