Following up on a bipartisan effort to keep down the costs of insulin, U.S. Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) reintroduced a bill on April 20 to ensure patients with diabetes can access the life-saving medicine without the excess costs associated with drug rebates and stymied competition.
Type 1 diabetes mellitus (T1DM) is an autoimmune disease in which the person’s immune system destroys its own pancreatic islet cells that leads to complete loss of insulin production. Allogeneic pancreatic islet cell transplantation has been shown to replenish the vanished β-cell population and provide glycemic control, restoration of hypoglycemia awareness, and protection from severe hypoglycemic events. However, with allogeneic transplantation, there is a need for life-long immunosuppression to protect the islet grafts from allo- and autoimmunity.
In collaborating with Novo Nordisk A/S, privately held Aspect Biosystems Ltd. entered its biggest ever deal that could bring in more than $2.6 billion while advancing its 3D, bioprinted tissue therapeutics technology. The two companies will collaborate to develop up to four diabetes and/or obesity products, a Novo specialty, using implantable bioprinted tissues to replace, repair or supplement human biological functions. The initial target will be type 1 diabetes.
Ixlayer Inc. expanded access to diabetes screening by offering its test via retailers, health systems and payers, making it easier for consumers to measure and track their blood glucose levels without requiring a doctor’s visit or prescription. If an individual’s test results indicate that they have or are at risk of developing diabetes, however, the company will offer to connect them with a health care provider available through the reseller’s network to discuss next steps.
A deal worth $745 million for two small-molecule programs, with a lucrative option to expand into other modalities, brings together the diabetes and metabolic disease expertise of Novo Nordisk A/S with an artificial intelligence technology platform from Dewpoint Therapeutics Inc. Boston-based Dewpoint signed on with Bagsvaerd, Denmark-based Novo Nordisk to use the former’s biomolecular condensates discovery engine to find new drugs for diabetic complications. The drugs will target condensates that contribute to the mechanisms of insulin sensitivity and insulin resistance, a key driver of type 2 diabetes and metabolic syndrome.
An artificial pancreas system that draws on research conducted at the University of Virginia to effectively combine Dexcom Inc.’s continuous glucose monitor and Tandem Diabetes Care Inc.’s artificial intelligence-enabled insulin pump works effectively in children under 6 years of age with type 1 diabetes, a study published in the New England Journal of Medicine showed.
Shares of Provention Bio Inc. (NASDAQ:PRVB) closed March 13 at $24.10, up $17.40, or 259%, after Wall Street learned that collaborator Sanofi SA intends to acquire the firm for $25 per share in cash, which works out to an equity value of about $2.9 billion. The transaction brings Paris-based Sanofi the type 1 diabetes (T1D) therapy Tzield (teplizumab-mzwv), approved by the U.S. FDA in 2022 as the first and only therapy to delay the onset of stage 3 disease in adults and in pediatric patients ages 8 and older with T1D that has reached stage 2.
Three months earlier than anticipated, CMS published its final local coverage determination (LCD) for continuous glucose monitors and included more people with diabetes than expected. The new policy expands coverage from individuals with type 1 diabetes or type 2 diabetes using multiple daily injections of insulin to anyone treated with insulin, essentially doubling the market for manufacturers of continuous glucose monitors (CGMs).
U.S. Sen. Bernie Sanders (I-Vt.) sent letters to Sanofi SA and Novo Nordisk A/S executives on March 1, urging them to follow Eli Lilly and Co.’s example in cutting prices for their insulin products, offering more affordable access for Americans with diabetes. Industry leaders, however, have long argued that the problem goes far beyond list price, as pharmacy benefit managers and health plans have simply not passed their rebates onto consumers.
Insulet Corp. reported much better than expected fourth quarter results, following on Dexcom Inc.’s report of earlier than expected coverage decision from CMS for its just-approved G7 continuous glucose monitor. Insulet (NASDAQ:PODD) soundly beat Wall Street’s expectations for quarterly revenue by $38 million, bringing in $332 million instead of the anticipated $332 million, driven by strong uptake of its Omnipod tubeless insulin pump.
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