PHARMACY

Study: Insulin production found among those with long-term Type 1 diabetes

BY Allison Cerra

BOSTON — It seems insulin production and beta cell functioning may persist despite the onset of Type 1 diabetes, according to research conducted at the Massachusetts General Hospital and published in the March issue of Diabetes Care.

Researchers evaluated blood samples of 182 individuals with Type 1 diabetes using an ultrasensitive assay for C-peptide, a marker of insulin secretion, to test for residual beta cell function. What they discovered was that although C-peptide levels were lower among those who had longer duration of diabetes; however, the decrease over time was gradual, compared with the predicted abrupt decline that typically is associated with Type 1 diabetes. For example, among patients with disease duration of 31 to 40 years, 10% still produced C-peptide. What’s more, beta cell functioning remained intact at very low C-peptide levels.

"Traditionally, it was thought that beta cell function completely ceased in patients with advanced Type 1 diabetes. However, data from this study and others suggest that the pancreas continues to function at some level even decades after the onset of Type 1 diabetes," said Denise Faustman, director of the MGH Immunobiology Laboratory, who led the study.


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PHARMACY

Novartis to pay $440 million for hepatitis C drug

BY Alaric DeArment

WATERTOWN, Mass. — Novartis plans to pay up to $440 million for rights to a drug for treating hepatitis C made by Enanta Pharmaceuticals, Enanta said.

Enanta said it had made a licensing agreement with the Swiss drug maker for the worldwide development, manufacturing and commercialization of the drug EDP-239, which works by inhibiting NS5A, a protein that is key to the virus’ replication.

"Novartis is a recognized leader in the field of HCV, and access to its global expertise combined with our shared vision for commercializing HCV therapies will support the successful development and commercialization of products targeting NS5A," Enanta president and CEO Jay Luly said.

Under the agreement, Novartis will pay Enanta $34 million upfront plus up to $406 million in milestone payments based on successful clinical, regulatory and commercial outcomes.


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GPhA applauds FDA’s action to address shortage of Doxil, methotrexate

BY Allison Cerra

WASHINGTON — The Food and Drug Administration’s action to address the ongoing shortage of certain cancer drugs has garnered praise from a group representing the manufacturers and distributors of generic pharmaceuticals.

The Generic Pharmaceutical Association said it applauded the FDA’s action to address the shortage of cancer drugs Doxil (doxorubicin hydrochloride liposome injection) and preservative-free methotrexate. GPhA also added that generic drug manufacturers are tirelessly working with regulators to provide needed supplies of the critical medicines.

“As FDA commissioner Margaret Hamburg said this morning, patients and families waiting for these drugs will soon be able to get the medication they need thanks to the collaborative work of FDA, industry, and other stakeholders,” GPhA president and CEO Ralph Neas said. “GPhA is spearheading the development of the Accelerated Recovery Initiative — an unprecedented multi-stakeholder undertaking that would work with entities across the supply chain to enhance communication and strengthen our collective ability to prepare for potential shortages and make sure patients do not face situations where their medicines are not available.”


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