What’s going on in the news…
Good work is being done and progress is being made to improve the quality of life and outlook for those most vulnerable people who suffer from type 1 diabetes by way of widening the scope of recent successes like the “artificial pancreas” by Medtronic. Expertise in evaluating the response of medical devices and related active pharmaceutical ingredients is critical to providing a full spectrum of support to clients. Superior Toxicology & Wellness has 30 years of toxicology experience behind its work.
Medtronic has received FDA approval to expand the use of its artificial pancreas.
In a double boost for patients with diabetes, the FDA signed off on expanding the use of Medtronic’s hybrid closed-loop insulin pump system to include patients between the ages of 7 to 13 with Type 1 diabetes and approved the Eversense continuous glucose monitoring (CGM) system for patients 18 and older. The Eversense device is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days. Considered the world’s first “artificial pancreas,” the Medtronic’s MiniMed 670G was first approved by the regulatory agency last year for use in patients with Type 1 diabetes aged 14 and older.
“Advances in science, technology and manufacturing are contributing to the development of new and expanded uses of products that can help improve the quality of life for those with chronic diseases, especially vulnerable populations, like children,” Scott Gottlieb, M.D., the FDA commissioner, said in a statement. “Today we’re extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks.”
In reviewing the device for use in the new age bracket, the FDA evaluated data from a clinical trial of the device that included 105 patients aged 7 to 11 years old. Study participants wore the MiniMed 670G for about 3-1/2 months and took part in three phases of the study to evaluate both at-home use as well as remote use. That study found no serious adverse events associated with use of the MiniMed 670G and that the device is safe for use in people age 7 to 13 years with Type 1 diabetes, the agency said.
The entire article can be found at this link: https://www.fiercebiotech.com/fda-expands-use-medtronic-s-artificial-pancreas-to-younger-type-1-diabetics.
Alzheimer Disease Program
Chronic progressive diseases such as Alzheimer’s can be extremely debilitating to patients. New treatments to slow or stop the progression provide hope to patients and families.
ProMIS Neurosciences Advances Alzheimer’s Disease Program
ProMIS Neurosciences continues to further develop antibody candidates that have shown selectivity for the toxic forms of tau. New pre-clinical data show that these antibody candidates can block the spread of pathogenic tau aggregate formation in a cellular model. Continued advancement of ProMIS’ dual approach for Alzheimer’s disease, which also includes antibody PMN310 targeting the toxic oligomers of amyloid-beta, aligns with research indicating that both misfolded proteins play a major role in disease progression and represent highly validated targets for therapy.
ProMIS announced its tau program in May 2019 when it identified several novel antibody candidates that preferentially bind toxic forms of tau. Pre-clinical data now show that these candidates can block the formation of pathogenic tau aggregates in a cellular model. ProMIS leveraged its proprietary drug discovery and development platform to identify conformational epitopes on misfolded tau and generate, evaluate and advance tau antibody candidates, demonstrating the platform’s capacity for producing high-quality antibody candidates rapidly and cost-effectively.
The entire article can be found at this link: https://www.americanpharmaceuticalreview.com/1315-News/518777-ProMIS-Neurosciences-Advances-Alzheimer-s-Disease-Program/
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Dr. Joe Nieusma and the Superior Toxicology & Wellness Team