Both Novo Nordisk (NYSE:NVO) and Sanofi (NYSE:SNY) said yesterday that they won FDA approval for pre-filled pens with drug combinations indicated for adults with Type II diabetes. Paris-based Sanofi’s Soliqua 100/33 is an injectable medicine composed of 2 diabetes drugs – insulin glargine and lixisenatide. The drug is approved for adults with Type II diabetes not controlled with less than […]
Food & Drug Administration (FDA)
Ivenix CEO Randle looks to reboot the infusion pump
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 […]
FDA clears Ascensia’s Contour Next One blood glucose monitor
Ascensia Diabetes Care said today that it won FDA 510(k) clearance for its Contour Next One blood glucose monitoring system. The connected system features a blood glucose meter that links to mobile devices using Bluetooth through the Contour Diabetes app. The app can collect, store and analyze the patient’s blood glucose measurements for patterns and […]
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 […]
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 […]
PixarBio raises $7m for non-addictive morphine alternative
PixarBio (OTC:PXRB) raised $7 million for its biomaterial-based opioid alternative for post-operative acute and chronic pain relief, about 18% of its $40 million equity financing according to a regulatory filing that the Medford, Mass.-based company filed yesterday. The company’s drug delivery product, NeuroRelease, is an injectable morphine replacement therapy for use in the surgical/hospital setting, the […]
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 […]
OCUL’s Dextenza meets endpoints in pivotal study
Ocular Therapeutix (NSDQ:OCUL) said today that its post-surgical ocular pain reliever, Dextenza, met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain. The product is a bioresorbable intracanalicular insert, designed for drug release to the ocular surface for up to 30 days. The randomized, double-masked study enrolled 438 patients who were […]
Ocular Therapeutix plans FDA re-submission for Dextenza by end of year, earnings
Shares in Ocular Therapeutix (NSDQ:OCUL) surged this morning after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results and announced it will re-submit its new drug application to the FDA for Dextenza, its post-surgical ocular pain reliever, by the end of the year. In July, the FDA denied approval for Ocular’s hydrogel plug designed […]
