The FDA cleared DarioHealth‘s (NSDQ:DRIO) iPhone-compatible blood glucose monitoring system, enabling users to access the company’s Dario app on iPhone 7, 8 and X mobile devices. The Israel-based company’s product is designed to work with Apple’s latest smartphones, which feature a Lightning connector in place of a standard headphone jack. DarioHealth’s platform includes a blood […]
Acorda seeks EU approval for inhaled Parkinson’s disease drug
Acorda Therapeutics (NSDQ:ACOR) submitted a marketing authorization application to the European Medicines Agency for its inhaled Parkinson’s disease therapy, Inbrija, according to the Ardsley, N.Y.-based company. The investigational drug is designed to treat people with Parkinson’s disease who are experiencing “off” periods, or a re-emergence of symptoms. Acorda’s marketing application for Inbrija includes data from a […]
FDA aims to curb ingredient list for drug compounders
The FDA issued draft guidance last week designed to limit the list of pharmaceutical ingredients that drug compounding pharmacies can use to manufacture drugs in bulk that do not undergo the agency’s traditional approval process. The move comes in the wake of a deadly 2012 fungal meningitis outbreak that originated from contaminated drugs made in […]
EU committee backs dosing changes for Bristol-Myers Squibb’s immunotherapy
A committee for the European Union’s pharmaceutical regulatory agency backed changes to the dosing schedule for Bristol-Myers Squibb‘s (NYSE:BMY) Opdivo cancer drug, the company touted today. The Committee for Medicinal Products for Human Use recommended that the European Commission approve a dosing schedule of 480-mg infused over 60 minutes every four weeks as an option […]
NIH study finds islet transplants improve quality of life for people with Type I diabetes
A Phase III trial funded by the National Institutes of Health found that quality of life for people with type I diabetes improved dramatically following transplantation of insulin-producing pancreatic islets, according to data published this week in the journal Diabetes Care. The 48-patient trial involved participants with hypoglycemia unawareness, a condition that renders them unable to […]
BD finds chemical from blood collection tube interferes with Magellen lead test
Studies conducted by Becton Dickinson (NYSE: BDX) found that a chemical present in its Vacutainer blood collection tubes interfered with lead tests made by Magellan Diagnostics. The FDA first warned consumers in May of 2017 that Magellan’s lead tests may provide inaccurate results when used with blood drawn from the vein and held in BD’s blood collection […]
Alere forks over $33m to settle DOJ inquiry
The U.S. Dept. of Justice said today that Abbott‘s (NYSE:ABT) Alere (NYSE:ALR) agreed to pay $33.2 million to resolve allegations that it knowingly sold unreliable point-of-care diagnostic devices, causing hospitals to submit false claim to Medicare, Medicaid and other federal healthcare programs. The U.S. alleged that Alere sold materially unreliable Triage devices, which are designed to diagnose […]
Japan approves Novo Nordisk’s once-weekly Type II diabetes drug
The Japanese Ministry of Health, Labor and Welfare gave Novo Nordisk (NYSE:NVO) the green light to market its once-weekly type II diabetes drug, Ozempic, Reuters reported today. The pharma company’s drug, semaglutide, is a glucagon-like peptide-1 analog that mimics an intestinal hormone to trigger insulin production in people with diabetes. Novo Nordisk expects to launch Ozempic in Japan in […]
Piedmont Healthcare expands use of Glytec’s insulin dosing decision software
Piedmont Healthcare, which uses Glytec‘s insulin therapy tech at three of its hospitals, plans to expand use of the eGlycemic Management System to all of its acute care facilities. Glytec’s software features evidence-based insulin dosing decision support, surveillance of blood glucose values to identify patients at risk of low and high blood sugar, real-time alerts […]
Genentech’s pre-filled syringe for diabetic retinopathy wins FDA nod
Roche‘s (OTC:RHHBY) Genentech announced today that the FDA approved its 0.3-mg pre-filled syringe as a new way to administer Lucentis to diabetic retinopathy patients. The company’s drug is the only FDA-approved medicine indicated for the treatment of diabetic retinopathy. The 0.3-mg pre-filled syringe is the first device of its kind approved to deliver an anti-vascular endothelial […]
