FDA Releases Guidance on Biosimilars

FDA Releases Guidance on Biosimilars

Drug developers now have the guidelines to understand which studies and considerations are needed to demonstrate that their biosimilar is interchangeable with a reference product.

Medtronic 670G Pump Users Experienced Optimal Blood Sugar Range 71 Percent of the Time

The medtech company unveiled CareLink data showing that the automated basal delivery feature of the pump system helped people with type 1 diabetes experience improved Time in Range.

Pivotal Home Trial of iLet Bionic Pancreas System Announced

The trial is being conducted by Beta Bionics and Zealand Pharma, and marks the first full-scale test of the dual-hormone therapy in a real-world setting.

Theresa May, a UK Prime Minister with Type 1 Diabetes, Resigns

Prime Minister May is apparently the first world leader who has openly served with type 1 diabetes.

A Type 1 Diabetes Diagnosis Has Helped This Doctor Help Patients with Diabetes

A profile of Dr. Michael Heile of The Family Medical Group-Cincinnati.

Colorado Law Caps Insulin Monthly Insulin Costs at $100 for Insured Patients

-Craig Idlebrook Yesterday, Colorado governor Jared Polis signed into law a measure that will cap total monthly insurance co-pays for insulin at $100. All insurers in the state will have to comply with the new regulation by January 1st, 2020. The measure caps out-of-pocket costs for a 30-day supply of insulin at $100 for Coloradans […]

A father who was diagnosed with type 1 diabetes later in life describes how his family has rallied behind him after his diagnosis, and how the 24/7 blood sugar management is still difficult despite the help.

Senseonics announced a distribution partnership with a verified Service-Disabled Veteran-Owned Small Business to offer the implantable CGM through the Veterans Health Administration.

DIY Automated Insulin Dosing Stakeholders Issue Statement to FDA Warning Against Such Systems

The statement has reportedly been endorsed and co-written by key members of the Loop, OpenAPS, and AndroidAPS movements.

The agency says it has received word of an accidental insulin overdose that occurred with an automated insulin dosing system.