Novocure (NSDQ:NVCR) touted data today from the Phase III pivotal trial of its Optune device in combination with temozolomide for the treatment of newly-diagnosed glioblastoma. The analyses were presented at the American Society for Radiation Oncology’s 2017 annual meeting in San Diego. Get the full story at our sister site, Drug Delivery Business News.
Drug-Device Combinations
Keeping a patient’s lungs clean & expanded after surgery: a Drug Delivery Business News podcast
Every year, more than 1 million patients in the U.S. find themselves suffering from respiratory complications following surgery, according to Hill-Rom. These complications come at a cost – to both the patient and the hospital. A respiratory problem can increase a patient’s time in the hospital by as much as 89%. More people die each year […]
Delcath deal with investors raises $500k, clears path for reverse split
Delcath Systems (NSDQ:DCTH) and a group of investors made an end run around the company’s shareholders with a deal that paves the way for the reverse split that stockowners have twice shot down. “Together with our Board of Directors, we are taking these actions in the best interests of all shareholders. Regaining access to equity capital will […]
Convenience, compliance & control: How Insulet is changing insulin delivery tech
Shacey Petrovic spent nearly a decade trying to convince her diabetic father to switch to an insulin pump, rather than inject himself multiple times each day. But he was wary of the tubing and other challenges that come with constantly wearing a pump. So when Petrovic was tapped to serve as chief commercial officer at Insulet (NSDQ:PODD) in February 2015, […]
Reva Medical’s Fantom bioresorbable, drug-eluting vascular scaffold succeeds at 6 months
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 […]
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 […]