ALR Technologies said today that the FDA approved the insulin dose adjustment feature of its ALRT diabetes management system. The ALRT system uses insulin dosing guidelines from the American Association of Clinical Endocrinologists and American Diabetes Association as reference doses. The reference doses are compared with a patient’s current insulin dose to decide if a patient’s […]
Drug-Device Combinations
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 […]
Dexcom launches program to connect CGM data with 3rd-party apps
Dexcom (NSDQ:DXCM) today launched a public API that allows 3rd-party developers to connect patient-authorized continuous glucose monitoring data into software apps. The data-sharing platform is designed to make use of the blood glucose data produced by Dexcom’s CGM systems. Companies, including One Drop, have begun accessing the API and others in the U.S. can register online, […]
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 […]
FDA’s medical gas guidance offers clarity to manufacturers
FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]
Braeburn’s buprenorphine depot wins priority review from FDA
Braeburn Pharmaceuticals said today that the FDA granted priority review to the company’s CAM2038 NDA. The investigational weekly and monthly buprenorphine depot injection was designed to treat adults with opioid use disorder. The regulatory agency is slated to make a decision about CAM2038 by January 10, 2018. “FDA’s acceptance of our NDA for CAM2038 under […]
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 […]
Microneedle skin patch delivers fat-burning drug in mouse trial
Researchers have created a drug-filled microneedle skin patch that helps convert energy-storing fat, or white fat, into energy-burning fat, or brown fat – all the while boosting the body’s metabolism. The team of researchers at Columbia University Medical Center and the University of North Carolina reported that their patch could one day be used to burn […]
Fast-dissolving opioid dependence tablet wins EU recommendation
Mundipharma International and Orexo (STO:ORX) said today that its fast-dissolving Zubsolv buprenorphine and naloxone sublingual tablet won a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The European Commission is slated to make a final decision about the product’s marketing authorization by the end of this year, the companies […]