// January
In January, California sued insulin makers and PBMs over alleged price collusion. Oramed’s oral insulin failed in a phase 3 trial. TheracosBio’s Brenzavvy got FDA approval for diabetes. Eli Lilly invested $450 million in diabetes drug production.
California's Office of the Attorney General contends that drugmakers and pharmacy benefit managers work together to “aggressively raise the list price of insulin in lockstep with each other to artificial levels.” Insulin manufacturers deny the allegations, pointing to availability of lower-cost versions of their products.
Oramed Pharmaceuticals’ dream of developing an oral insulin for type 2 diabetes looks to be over. With the candidate failing to beat placebo in a phase 3 trial, the biotech outlined plans to stop development and sent its share price tumbling in the process.
California Attorney General Rob Bonta on Thursday sued the six major companies that dominate the U.S. insulin market, ratcheting up the state’s assault on a profitable industry for artificially jacking up prices and making the indispensable drug less accessible for diabetes patients.
The FDA approved TheracosBio’s Brenzavvy as a treatment for type 2 diabetes. But before it won a regulatory nod for controlling blood glucose in adults, it was approved at a different dose (with flavor) as a veterinary product.
Eli Lilly will invest $450 million in a North Carolina manufacturing plant to meet growing demand for its diabetes drugs Mounjaro and Trulicity, the company said Tuesday.
// February
In February, Eli Lilly’s Mounjaro diabetes drug saw strong sales. Blue Shield of California expanded its Virta Health partnership for diabetes care. President Biden called for insulin cost caps. Insulet acquired Bigfoot’s insulin pump patents. Eli Lilly resolved a Mounjaro shortage amid high demand.
Sales of Eli Lilly’s new diabetes drug Mounjaro grew strongly in the final quarter of 2022, the company reported Thursday, challenging the market position of competing medicines from rival Novo Nordisk.
Virta is available this month to all Blue Shield of California members enrolled in preferred provider organization plans for individual and family, fully insured, self funded and Medicare Advantage. The payer has been working with Virta since 2019 when the digital health company joined Blue Shield of California’s Wellvolution, a platform of digital lifestyle apps.
President Biden doubled down on efforts to rein in prescription drug prices during his State of the Union address on Tuesday and warned Republicans that he will fight any attempts to roll back his initiatives.
Insulet and Bigfoot offer two distinct forms of diabetes-management care: Insulet's Omnipod system that delivers insulin via a wearable, tubeless pump dubbed the Pod; and a remote controller called the Personal Diabetes Manager (PDM).
After an FDA approval last year, Eli Lilly’s diabetes drug Mounjaro has been on fire right out of the gate. Now, the Indianapolis pharma giant says it's resolved a months-long shortage.
// March
A lot happened in March! Eli Lilly cut insulin prices by 70%. Sanofi acquired Provention Bio, and Novo Nordisk followed Eli Lilly, reducing insulin prices. California chose Civica for low-cost insulin production. Enable Biosciences relaunched its Type 1 diabetes detection website. Lastly, Novo Nordisk partnered with Dewpoint Therapeutics for diabetes research.
Eli Lilly is cutting the price of its insulin products, announcing Wednesday a plan to reduce the cost of its branded drug Humalog and set a $25-per-vial cap on a non-branded Humalog alternative. The company is also launching a copycat version of Sanofi’s long-acting insulin Lantus at a 78% discount.
The drug maker Eli Lilly said Wednesday that it will cut the sticker price of some insulin products by 70%, and Democrats are taking a victory lap. Well, yes, government coercion can work. But the supposed pricing triumph here is far less than meets the press releases, and the truth is worth noting for the future of drug innovation for Americans with diabetes and other diseases.
Eli Lilly would’ve had to pay Medicaid about $150 for each vial of insulin used in the program if it hadn’t dramatically cut the list prices for some of its older products this week.
French pharmaceutical company Sanofi on Monday said it will pay $2.9 billion to acquire Provention Bio, a biotechnology company that recently won U.S. approval of a new type of Type 1 diabetes drug.
The FDA says an iCGMs can link to an AIDs! The U.S. Food and Drug Administration (FDA) has cleared Abbott’s FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system sensors for integration with automated insulin delivery (AID) systems. This clearance is a significant step forward in diabetes management technology, and this integration could affect how millions of people around the world administer their insulin. Abbott says its FreeStyle Libre portfolio has “changed the lives of 4.5 million people across more than 60 countries.”
On Tuesday, the Danish company said it would reduce the list price of its NovoLog insulin by 75% and slice the cost of Novolin and Levemir by 65%. The cuts will kick in on Jan. 1 of 2024, the drugmaker said.
Gov. Gavin Newsom on Saturday announced the selection of Utah-based generic drug manufacturer Civica to produce low-cost insulin for California, an unprecedented move that makes good on his promise to put state government in direct competition with the brand-name drug companies that dominate the market.
Enable Biosciences, a biotechnology company dedicated to developing innovative diagnostics, announced the relaunch of its website, type1testing.enablebiosciences.com, which offers an at-home testing kit for the early detection of type 1 diabetes.
Novo Nordisk and Dewpoint Therapeutics are partnering up in efforts to treat insulin resistance and diabetic complications, with the Danish Big Pharma offering up the possibility of $745 million in biobucks.
// April
In April, Senator Bernie Sanders plans to question insulin company CEOs on affordability, while Eli Lilly sells its diabetes drug Baqsimi to Amphastar for $500 million upfront with potential additional payments based on sales milestones.
Sen. Bernie Sanders plans to call the chief executives of the country’s largest insulin manufacturers to testify before his health committee, according to insulin maker Eli Lilly and two sources familiar with the plans. The move will keep the pressure on the companies over their prices despite the fact that they have said they plan to lower the list price of their older insulin products.
Eli Lilly will sell its emergency diabetes treatment Baqsimi to Amphastar Pharmaceuticals for $500 million upfront, the company said Monday, divesting a drug launched four years ago that had $139 million in sales last year.
// May
Artificial pancreas systems synchronize an insulin pump and continuous glucose monitor with the goal of delivering an almost completely hands-off approach to diabetes management—and the newest one cleared by the FDA aims to make that goal even easier to achieve.
Fresh off reaching a resolution with the FDA over a warning letter concerning its diabetes business headquarters in California—which in turn came just as the agency finally handed down the long-awaited clearance of Medtronic’s latest MiniMed insulin pump—the company has inked a deal to further expand the portfolio.
// June
In June, AstraZeneca dropped its GLP-1 candidate. FDA approved Jardiance and Synjardy for pediatric Type 2 diabetes. Vertex partnered with Lonza for a diabetes cell therapy facility, with promising results from VX-880.
Two months after dropping one of its GLP-1 agonists, AstraZeneca has decided to scrap its remaining clinical candidate. A preliminary analysis of the phase 1 data convinced the company that the drug would not outperform the competition.
Tuesday, the FDA approved Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) in children with Type 2 diabetes aged 10 years and above.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Lonza (SIX: LONN) today announced a strategic collaboration to support the manufacture of Vertex’s portfolio of investigational stem cell-derived, fully differentiated insulin-producing islet cell therapies for people with T1D, currently focusing on the VX-880 and VX-264 programs that are currently in clinical trials.
Vertex could be “leading the path to insulin independence," according to analysts, after another batch of data showed that the off-the-shelf diabetes cell therapy stimulated insulin production in all evaluable patients, and that two were now insulin independent.
// July
In July, CellTrans gained FDA approval for its cell therapy Lantidra for type 1 diabetes, while other firms explore diverse approaches to cell therapy for the condition.
Insulin independence is a goal of type 1 diabetes drug research and cell therapy holds promise to achieve it. Several biopharmaceutical companies have programs in various stages of development for the autoimmune disorder. A small, little-known biotech company has beaten all of them to win the first FDA approval of a cell therapy for type 1 diabetes.
// August
For 17 years, Kristen Whitney Daniels has been a Type 1 diabetic, needing regular doses of insulin to stay healthy. Having auto-immune disorders isn’t cheap: Whitney Daniels typically reaches her insurance’s annual $3,000 out-of-pocket maximum in about two months.
Wegovy, one of several drugs now surging in popularity due to their potent weight-loss effects, can also protect the heart, according to results from a large international study called SELECT.
// September
A Food and Drug Administration advisory committee voted unanimously on Thursday afternoon to reject an appeal for Intarcia Therapeutics’ Type 2 diabetes drug-device combination treatment, citing continued safety concerns.
Abbott and Bigfoot announced the purchase Tuesday, though they didn’t disclose its financial terms. The sale is expected to be completed sometime in the third quarter of this year.
// October
In October, Egyptian health tech Almouneer raised $3.6 million for its diabetes and obesity platform. Novo Nordisk’s semaglutide showed promise in treating kidney disease, leading to the early end of a clinical trial.
Obesity and prediabetes are major health concerns in Africa and the Middle East, affecting more than 40% of the population. In Egypt, 20% of adults have diabetes; the figure in Saudi Arabia is 30%. In Nigeria, one in 17 adults has diabetes. The issue of prediabetes and obesity is even more widespread. Yet, it’s essential to recognize that these health challenges are largely preventable through lifestyle management and monitoring.
The ability of Novo Nordisk’s semaglutide to lower blood sugar and reduce weight has made it a blockbuster seller for addressing type 2 diabetes and obesity. Now it looks like the drug can treat chronic kidney disease.
// November
Clinical trials have shown that lifestyle programs — which include diet, exercise, and behavioral coaching — can help people in danger of developing type 2 diabetes from tipping into a diagnosis of the condition. But there’s been a nagging question of whether such intensive regimens work in the real world.
// December
The White House today will take a long-awaited step to potentially broaden the government’s authority to undermine patents for medicines developed with taxpayer funding — including considering a drug’s price as one part of the framework, my co-author Sarah and I report.