Immunotherapy to treat people with type 1 diabetes genotype granted fast track designation by Jill Rollet for Healio.com/endocrinology, 16 February 2024.
The FDA granted fast track designation for an immunotherapy to treat type 1 diabetes among people with the human leukocyte antigen DR3-DQ2 genotype, according to a press release. The immunotherapy will be invested in the phase 3 DIAGNODE-3 trial.
“We are very pleased with the FDA’s decision to grant fast track designation for Diamyd and the potential this provides to accelerate Diamyd’s path to entering the U.S. market,” Ulf Hannelius, CEO of Diamyd Medical, said in the release. “Type 1 diabetes is a progressive, chronic and irreversible autoimmune disease that affects millions of patients worldwide. Diamyd … represents a significant shift towards personalized medicine in the treatment of type 1 diabetes.
Read more: Immunotherapy to treat people with type 1 diabetes genotype granted fast track designation
Pharmaceutical group’s lawsuit over Medicare drug price program dismissed by Nate Raymond for Reuters.com, 13 February 2024.
A federal judge dismissed a lawsuit by a major pharmaceutical industry trade association challenging a new program that allows Medicare to negotiate prices with drug companies for selected costly drugs. U.S. District Judge David Ezra in Austin, Texas, dismissed a lawsuit by the Pharmaceutical Research and Manufacturers of America (PhRMA) and two other groups that argued that the program was unconstitutional.Medicare Coverage Significantly Expanded for the Eversense E3 CGM System was posted by BusinessWire.com, 12 February 2024.
Ascensia Diabetes Care, a global diabetes care company, and Senseonics Holdings, Inc., a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced that Medicare has significantly expanded access to the Eversense E3 CGM System, the longest lasting CGM available, with the implementation of Local Coverage Determinations providing access to implantable CGM for basal only patients, by the first three Medicare Administrative Contractors (MACs).
Medicare coverage has been expanded for implantable CGMs to include all people with diabetes using insulin, removing the previous requirement for multiple insulin administrations per day. The new policy has also been updated to cover non-insulin users who have a history of problematic hypoglycemia. Noridian, Palmetto, and National Government Services (NGS) are the first three MACs to publish final local coverage determinations (LCD). The earliest MAC expansion becomes effective on February 25, 2024 and the companies expect the remaining MACs to finalize their expansion in the near future.
“We welcome this policy change and look forward to bringing this differentiated CGM option to millions of more Americans through Medicare,” said Rudy Thoms, VP, CGM Commercial US of Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE: 6523). “Eversense E3 is a truly unique technology and optionality is key in diabetes care, where what works for one person does not always work for all. In particular, our Medicare users love that this twice-yearly CGM offers them unparalleled reliability and flexibility, without the burden of regular self-insertions and the constant reordering of supplies. It is important that people with diabetes have the same access to the benefits of a fully implantable, long-term CGM, as they do to traditional CGMs [that have a much shorter lifespan], and so we are thrilled to see this expansion.”
Read more: Medicare Coverage Significantly Expanded for the Eversense E3 CGM System
A FEW BOOKS LEFT in the Book Giveaway of Haidee Soule Merritt’s Insulin Surplus Zine: Possible Uses for the Insulin Surplus (IF there’s ever a cure for diabetes).
I still have 4-5 copies ($8.50 value, postage included), free for the asking, until I run out of ezines. It’s a fun, little booklet of cartoons about living with T1D … will make you giggle … and also makes a great gift at any T1D meetup or gathering!
What’s the catch? Please tell me why you’d love a copy. I’ll share your comments with Haidee … and I will mail a booklet to you, with postage paid! Please email your mailing address: joanne@TheSavvyDiabetic.com. Some of my favorite cartoons …
CASTING CALL!!!
Looking for stories about your pet(s) who alert you for low or high blood sugars, WITHOUT any formal training. I’m fascinated with whatever instinct makes certain pets sensitive to your blood sugars and how they alert you or your loved ones. Please email me your stories and let me know if you will allow me to share your pet’s special skills and a photo on my blog.
I posted the following story several years back about Willow, the amazing alerting cat! She is amazing, all self-directed! Savvy Pets, 7/10/20: Willow, the Diabetes Alert Cat
The diabetes educator cartoon is now my favorite. Truth! I had a family member diagnosed with Type 2, still non-insulin dependent numerous years later, about 20 years after I got Type 1. He went to see a diabetes educator who insisted people with diabetes should never eat more than half a banana and he became convinced there would be no such thing as high or low glucose if this advice was strictly adhered too because he was told that by an “expert.” Sheesh.