Researchers studying 278 patients with in-stent restenosis found that B. Braun‘s SeQuent Please paclitaxel-eluting balloon was non-inferior to Abbott‘s (NYSE:ABT) Xience drug-eluting stent when it comes to six-month minimal lumen diameter. The study’s results were touted this week at the annual Transcatheter Cardiovascular Therapeutics conference in Denver, Colorado. Get the full story at our sister site, Drug […]
Drug-Device Combinations
Report: Seven deaths from EpiPen failures this year
Defective EpiPens have been cited in seven deaths this year so far, according to reports made to the FDA and obtained by Bloomberg News. During the same period, the FDA has received 228 reports of EpiPen failures and at least 35 people were hospitalized as a result of those failures. Get the full story at our […]
TCT 2017: Medtronic & OrbusNeich evaluate shortening dual antiplatelet therapy with drug-eluting stents
At this year’s Transcatheter Cardiovascular Therapeutics meeting, companies presented work comparing shortened durations of dual anti-platelet therapy with the standard 1-year regimen in patients treated with a drug-eluting stent. Among those companies were Medtronic (NYSE:MDT) and OrbusNeich. Here’s a look at what they found. Get the full story at our sister site, Drug Delivery Business News.
Biotronik’s Orsiro drug-eluting stent succeeds at five-year follow-up
Biotronik touted long-term safety and efficacy data for its Orsiro drug-eluting stent yesterday at this year’s Transcatheter Cardiovascular Therapeutics meeting. Data from the Bioflow-II trial and the Bioflow-III registry demonstrated that Biotroniks’s device boasts strong safety and clinical performance at five years, the company reported. Get the full story at our sister site, Drug Delivery Business […]
Here’s how Amaranth Medical plans to get ahead with its bioresorbable scaffold tech
There are two ways to make a bioresorbable, drug-eluting scaffold, according to Amaranth Medical CEO Kamal Ramzipoor. “The Amaranth way, or the conventional way, which our competition is using,” he told Drug Delivery Business News. “What we’ve seen throughout the years is the conventional method has some very significant limitations. And that’s what has manifested itself into, unfortunately, what’s going […]
Advisory committee backs Indivior’s once-monthly opioid use disorder treatment
Indivior (LON:INDV) said today that the FDA’s psychopharmacologic drugs advisory committee and drug safety and risk management advisory committee voted 18-1 recommending approval of the company’s once-monthly injectable treatment for opioid use disorder. The company’s RBP-6000 treatment is designed for adults with moderate-to-severe opioid use disorder. The FDA is slated to make a decision about Indivior’s […]
Reva, Biotronik tout safety data for their drug-eluting bioresorbable scaffolds
Despite the safety concerns plaguing Abbott‘s (NYSE:ABT) Absorb device, companies developing bioresorbable scaffolds are not discouraged. This week at the annual Transcatheter Cardiovascular Therapeutics Conference in Denver, a number of companies touted the safety data coming from clinical trials of their products. Among them were Reva Medical (ASX:RVA) and Biotronik – here’s an overview of that data. Get the full story at […]
One Drop partners with Fitbit to bring diabetes data to people’s wrists
One Drop announced yesterday that it landed a multi-part collaboration with Fitbit (NYSE:FIT). The group’s first initiative will be to integrate Fitbit’s data onto One Drop’s mobile app for diabetes management, the company said, in the hopes to helping users better understand how physical activity impacts blood glucose management. Get the full story at our sister site, Drug […]
Long-term data for Abbott’s Absorb “highlight the need for continued improvements” in BRS tech
Hours before Abbott (NYSE:ABT) presented three-year data from a pivotal trial of its Absorb bioresorbable scaffold, the FDA updated a letter to healthcare providers, writing that the device continues to show an increased rate of major adverse cardiac events and thrombosis compared to patients treated with a drug-eluting stent. “The FDA’s recommendations for health care providers outlined […]
Novo Nordisk shares slip on cautious guidance, insulin pricing concerns
Shares in Novo Nordisk (NYSE:NVO) fell slightly today after the insulin-maker met expectations on Wall Street with its third quarter results, but issued cautious sales guidance for 2018. The company’s chief executive expressed concerns that draft legislation to make drug pricing more transparent could potentially hurt the industry, according to Reuters. Get the full story at our sister […]
Study: Glooko’s mobile app boosts glycemic control in patients with Type II diabetes
Glooko touted data today from a feasibility study evaluating the impact of its mobile insulin dosing system for people with Type II diabetes who are taking long-acting insulin. The Mountain View, Calif.-based company said it hoped to better understand the extent to which its system can make appropriate insulin titration adjustments and improve a patient’s glycemic […]