Insulin Algorithms said today that its decision-support software, designed to help clinicians manage insulin for patients with diabetes, won FDA clearance. The company’s software allows clinicians to analyze a patient’s blood sugar measurements regularly and develop an optimized plan for the patient’s insulin regimen. The software was developed with algorithms that are clinically proven to lower […]
Drug-Device Combinations
Mylan shareholders vote against executive pay package, but re-elect board
At the company’s annual meeting, Mylan (NSDQ:MYL) shareholders re-elected the drugmaker’s board despite a campaign spearheaded by major investors to do otherwise. The campaign hoped to encourage shareholders to vote down most of the board’s directors in response to Mylan’s drug pricing practices for its EpiPen device. The influential proxy advisory firm, ISS, also urged shareholders […]
FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label. The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk […]
pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency. Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of […]
TriReme Medical touts Chocolate Heart drug-coated balloon data
QT Vascular subsidiary TriReme Medical touted angiographic data today from a 24-month follow-up of patients treated with its Chocolate Heart drug-coated balloon. The Chocolate Heart device is a paclitaxel-coated version of the company’s Chocolate coronary balloon that is commercially available in the U.S. The combo therapy was designed to reduce the incidence of repeat procedures […]
Sigilon Therapeutics launches with encapsulated cell therapy tech
Backed with $23.5 million from Flagship Pioneering, Sigilon Therapeutics launched today with a plan to leverage its biocompatible Afibromer technology with engineered cells to treat hematologic, enzyme deficiency and endocrine disorders. Sigilon’s Afibromer platform represents a new class of implantable biomaterials that don’t trigger fibrosis, the company said. Encapsulated cell therapies have failed in the […]
Cleveland Clinic spinout Infuseon inks deal with OncoSynergy
Infuseon Therapeutics inked a deal this week with OncoSynergy to evaluate a glioblastoma therapeutic with the Cleveland Clinic spinout’s novel delivery device. The alliance hopes to demonstrate proof-of-concept that OncoSynergy’s candidate can be successfully delivered directly to a patient’s brain using the device in a Phase I glioblastoma trial. Infuseon’s Cleveland Multiport Catheter, which won […]
Novartis trial results could spell trouble for Regeneron
Head-to-head late-stage clinical trials published on Tuesday showed that a Novartis (NYSE:NVS) drug to treat patients with neovascular age-related macular degeneration doesn’t need to be injected as frequently as a rival drug from competitor Regeneron (NSDQ:REGN). Analysts reportedly said the data gives Novartis’ treatment, RTH258, a competitive edge compared to its rival therapies. The trials showed […]
Glaukos touts iStent study with topical travoprost
Glaukos (NYSE:GKOS) touted data today from a 53-patient glaucoma study showing that its iStent device combined with topical travoprost reduced mean intraocular pressure by 35% after 18 months of follow-up. The company’s flagship device is designed to lessen IOP by restoring the natural outflow of aqueous humor through the conventional pathway in a patient’s eye. […]
BioDelivery Sciences brings novel drug delivery tech to pain management, opioid addiction
As the American public grapples with an ongoing opioid crisis, pain management companies are looking for ways to innovate their products in an attempt to avoid potential abuse. For years, BioDelivery Sciences International (NSDQ:BDSI) has developed mucoadhesive buccal films loaded with painkillers for pain management and addiction therapy. Now it is developing a buprenorphine depot […]
