As some companies have worked to improve drug-eluting stents by making them bioresorbable, some voices in the coronary intervention space have expressed concern over the rates of late stent thrombosis and repeat percutaneous coronary intervention seen with the devices. In a study published in the September issue of JACC: Cardiovascular Intervention, Reva Medical‘s (ASX:RVA) Fantom coronary bioresorbable […]
Drug-Device Combinations
UK warns about alarm failure for Roche’s insulin pumps
The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function. If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, the agency said. […]
Following regulatory win, GSK & Innoviva tout data for once-daily triple-med inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) notched a win this week after the FDA approved its once-daily, triple combination therapy for the treatment of chronic obstructive pulmonary disease. Last week, an EU agency recommended the inhaler’s approval. Now, the companies are touting results from a late-stage trial of Trelegy Ellipta, which is composed of an inhaled corticosteroid, a long-acting muscarinic antagonist and […]
Micell raises $62m for MiStent SES
Micell Technologies said last week that it raised a debt-and-equity round worth nearly $62 million from a syndicate of 51 unnamed investors. Paris-based Micell makes the MiStent SES sirolimus-eluting absorbable polymer coronary stent, designed to treat coronary artery disease. The company, which reported a nearly $26 million round last November, said in a regulatory filing that the […]
CIRSE 2017 Round-up: Delcath touts second-gen hemofiltration system in percutaneous hepatic perfusion
Delcath Systems (NSDQ:DCTH) touted data today from a study of its second-generation hemofiltration system in patients undergoing percutaneous hepatic perfusion with melphalan hydrochloride. The New York-based company presented the results from its study at the Cardiology and Interventional Radiology of Europe annual meeting in Copenhagen, Denmark. The investigational product, an injectable melphalan hydrochloride for use with […]
FDA approves GSK’s 3-in-1 Trelega Ellipta inhaler
The FDA has approved the triple inhaler developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) to treat chronic obstructive pulmonary disease, the companies reported today. The Trelega Ellipta dry powder inhaler uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD manage the condition. It is the first once-daily product approved in the U.S. that combines three active molecules […]
Teva sells off the rest of its women’s health assets in $2.5B deal
After the company divested its Paragard intrauterine device assets for $1.1 billion in cash last week, Teva Pharmaceuticals (NYSE:TEVA) announced today that it plans to sell off the rest of its global women’s health biz. Combined with proceeds from its Paragard deal, the sale of Teva’s global women’s health assets will total $2.48 billion, the company reported. Teva said […]
GSK’s triple-med COPD inhaler wins recommendation for approval in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency panel recommended marketing authorization for the Trelegy Ellipta triple-combination inhaler for adults with COPD. The device uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. It’s also the […]
VIVA 17 Round-up: Medtronic touts real-world data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon this week at the Vascular Interventional Advances (VIVA) 2017 conference. The company presented two-year, real-world data from the In.Pact Global study, as well as four-year results from the pivotal In.Pact SFA study. Get the full story at our sister site, Drug Delivery Business News.
US DHS warns of vulnerabilities in Smiths Medical Medfusion 4000 infusion pump
The US Dept. of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team has released a warning over issues with Smiths Medical’s Medfusion 4000 wireless syringe infusion pump after discovering 8 cybersecurity vulnerabilities in the device. The notice is for versions 1.1, 1.5 and 1.6 Medfusion 4000 wireless syringe infusion pumps, according to the DHS […]
Japan approves Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfar for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The […]