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During Hhs Nominee’s Tenure At Eli Lilly, Company Tripled Price Of A Top-selling Insulin Drug

During Hhs Nominee’s Tenure At Eli Lilly, Company Tripled Price Of A Top-selling Insulin Drug

President Donald Trump touted Alex Azar as a "star" who could help combat high drug prices. But Azar's history as a top pharma executive has critics worried. President Donald Trump tweeted Monday that his nominee for HHS secretary, Alex Azar will “be a star for … lower drug prices!” But the record of the former top executive for Eli Lilly, which tripled the price of a top-selling insulin drug while he led its U.S. operation, suggests a different story. Lilly is one of three drug companies targeted by a class-action lawsuit that accuses the company, then under Azar’s watch, of exploiting the drug pricing system to ensure higher profit for insulin and has been fined in Mexico for colluding on the pricing of the drug. (Karlin-Smith, 11/14) President Donald Trump’s tweet Monday announcing former pharmaceutical executive Alex Azar as his choice to lead the Department of Health and Human Services boasted that Azar “will be a star for better healthcare and lower drug prices!” But Azar, who led drugmaker Eli Lilly and Co.’s United States operations from 2012 until earlier this year, has contributed significantly to the pharmaceutical industry political spending that the president has decried. (Siddons, 11/15) In his quest to bring down drug prices, President Trump has advocated for policy proposals that the pharmaceutical industry opposes, including importing drugs from Canada. But his new health secretary pick — who, if confirmed, would immediately have the authority to kick-start some importation — has firmly rejected the idea. (Mershon, 11/14) The drug executive President Donald Trump has picked to lead the Department Health and Human Services isn’t likely to shy away from the topic of sky-high medication prices -- but it may be insurers and drug plans Continue reading >>

In Latest Blow To Eli Lilly, Sanofi Wins Fda Ok For Humalog Me-too

In Latest Blow To Eli Lilly, Sanofi Wins Fda Ok For Humalog Me-too

Sanofi $SNY got the greenlight from FDA to sell its me-too insulin product Admelog, threatening market leader Eli Lilly’s $LLY blockbuster sales in diabetes. Admelog, a short-acting insulin lispro injection, is a follow-on product approved through an abbreviated pathway under the FDA’s Federal Food, Drug, and Cosmetic Act. FDA Commissioner Scott Gottlieb is delivering on his promise to encourage more competition in the marketplace, cheering the approval in today’s statement. “One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives,” Gottlieb said. “This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease. In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.” Last year, Eli Lilly’s top selling product was Humalog, bringing in $2.76 billion in global sales. The drug is no longer protected by patents, but Lilly could win an extra 2.5 years of market exclusivity if it chooses to sue for infringement on its patent-protected KwikPen injection device, analysts have noted. The increased competition is the latest bad news for Lilly. The drugmaker has had a tough time realizing price increases due to payer playing hardball — pitting rival diabetes companies against each other to negotiate lower prices. This September, the company slashed R&D jobs, shuttered two research sites and announced plans to cut 3,500 staffers in hopes of saving $500 million in annual expenses. Continue reading >>

Fda Ok's Novo's Fast-acting Insulin Fiasp

Fda Ok's Novo's Fast-acting Insulin Fiasp

Reuters reports that the FDA has approved Novo Nordisk's (NVO -0.2%) fast-acting insulin aspart, branded as Fiasp. The company says it is designed to work faster than Eli Lilly's (LLY +0.2%) Humalog (insulin lispro injection) and its own NovoLog (insulin aspart injection). Fiasp was approved in Europe in January. Previously: Novo Nordisk refiles U.S. marketing application for fast-acting insulin aspart (March 29) Continue reading >>

Lilly Makes Big Push Into Devices To Protect Diabetes Sales

Lilly Makes Big Push Into Devices To Protect Diabetes Sales

Lilly makes big push into devices to protect diabetes sales Eli Lilly has unveiled its device-driven strategy for weathering the competitive and pricing pressures faced by its diabetes unit. The Big Pharma is working on insulin delivery devices that move it onto Medtronics turf and has teamed up with Dexcom to add continuous glucose monitoring systems to its arsenal. Lilly has quietly worked on an automated, wearable insulin delivery device and smart pen injector at a lab it opened in 2015, The Wall Street Journal reports . The facility in Cambridge, Mass., employs about 40 people with backgrounds far outside of Lilly's traditional core competencies, such as mechanical engineering, material science and industrial design. Lilly has bolstered the capabilities of its team by enlisting the support of an R&D group run by the inventor of the Segway scooter. The Big Pharma set up the unit after intuiting that the future of the diabetes market will belong to companies that monitor patients and deliver drugs rather than the businesses that make insulin itself. Like this story? Subscribe to FierceBiotech! Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go. RELATED: Medtronics long-awaited artificial pancreas makes U.S. debut That, like all R&D, is something of a risk, especially because it moves Lilly onto unfamiliar territory colonized by big businesses. Medtronic won FDA approval for an automated insulin delivery device last year and a clutch of other small and large medical technology companies are giving chase. Lillys entrant to t Continue reading >>

The Discovery Of Insulin: A Medical Marvel For The Sugar Sickness

The Discovery Of Insulin: A Medical Marvel For The Sugar Sickness

Eli Lilly and Company News of this miracle drug spread like wildfire, and diabetics rushed to be treated, clinging to hopes of relief. Insulin continued to become purified, and long lasting types were created to reduce the number of daily injections. Biosynthetic Insulin, introduced in 1983, eliminates the need for animal pancreases (Yuwiler 69-70). Synthesized insulin eliminates potential allergic reactions. Most insulins today are chemically identical to natural human insulin (Davidson). Though insulin is the most common option, new treatments include drugs that stimulate beta cells in the pancreas to release more insulin, decrease glucose production in the liver, or make muscles more responsive to insulin (Davidson). However, none of these advancements would be possible without insulin. Continue reading >>

Lilly Begins Phase 1 Study Of Automated Insulin Delivery System

Lilly Begins Phase 1 Study Of Automated Insulin Delivery System

Indianapolis-based pharmaceutical Eli Lilly and Company announced this week that the first Type 1 diabetes patient has been dosed in a feasibility study of the company’s investigational Automated Insulin Delivery (AID) system. The company’s hybrid closed-loop platform consists of an insulin pump with a dedicated controller for system inputs, a dosing algorithm, and a continuous glucose monitor (CGM). Each component of the AID system works together to automatically adjust insulin infusion rates to help patients keep their blood sugar level within a specified range, according to the company, and will be offered alongside a companion app for patients’ smartphones. To test the safety and functionality of the system, Eli Lilly’s study aims to provide 30 Type 1 diabetes patients with the AID system for approximately 12 to 18 days. Along with recording the number of participants who show a decrease, suspension or increase of insulin delivery within four hours of a challenge, the researcher will be looking to see how many participants resume the system’s automatic mode once they have restored CGM connectivity. This will be a single site trial, and is expected to conclude in April. The AID system is one of two platforms currently under works for Eli Lilly’s Connected Diabetes Ecosystem, with the other being an integrated insulin management system. This offering consists of a connected, glucose-sensing insulin pen and a software component designed to better deliver personalized dosage recommendations. Pending approval, the company said that it hopes to have these two offerings available to patients within the next two or three years. “All aspects of the Connected Diabetes Ecosystem are being developed with as much flexibility as possible,” Matthew Clemente, chief Continue reading >>

Eli Lilly’s New Ultra-rapid Insulin In The Works

Eli Lilly’s New Ultra-rapid Insulin In The Works

While Fiasp is now the only ultra fast insulin on the market, it won’t be the new kid for long. At least two other companies are hard at work bringing their own version of ultra fast acting insulin to a pharmacy near you. Pharmaceutical company Eli Lilly and Company says they are starting the late phases of clinical studies on an ultra fast insulin to go up against Novo Nordisk’s Fiasp, which is on the market in parts of Europe and in Canada. Lilly’s insulin will be for use in syringes, pens, and pumps and they plan to submit in 2019 for regulatory approval to multiple agencies in a global rollout that will include the United States. French biotechnology company Adocia is also in late stage development of an ultra rapid insulin but how and whether their drug might come to market is unknown since a collaboration between Adocia and Lilly was dissolved in January 2017. “Development of an ultra rapid insulin has been a priority for Lilly for years,” says Deirdre Ibsen, Platform Leader in the effort to develop and market the company’s ultra-rapid formulation. “We’ve had three efforts in development, including two internal efforts. Obviously we feel strongly that there is a role for ultra-rapid insulin in helping people better manage their diabetes.” Dr. Thomas Hardy, an endocrinologist and Senior Medical Director at Lilly, says the company has been working for more than six years on ultra rapid insulin formulations. He says Phase III clinical trials are about to begin, which is the last step before results of the trials are submitted to the Food and Drug Administration, the European Medicines Agency, and other regulatory agencies for approval. Hardy says the new insulin was formulated with two new excipients to speed up its action. One of those includes an Continue reading >>

Don’t Be Fooled By Eli Lilly’s & Express Scripts’ New Insulin Program

Don’t Be Fooled By Eli Lilly’s & Express Scripts’ New Insulin Program

If you’ve been preoccupied with Trump’s latest cabinet appointments, you may have missed the news about a new program sponsored by Eli Lilly and Express Scripts. With great fanfare, the two entities reported that beginning on January 1, 2017, they’ll provide a 40% discount on three Lilly diabetes drugs: Humalog, Humulin and Basaglar. They’ll do so through a free third party App called Blink Health that offers drug discounts to Blink Health users. According to Lilly and Express Scripts, their innovative new program will help Express Scripts’ beneficiaries cover the costs of the three medications, particularly while plan beneficiaries are trying to satisfy their plan deductibles. But is this program all that it purports to be? How does the program actually work? And what are the benefits of the program for its sponsors – Lilly and Express Scripts – and for those impacted by the program – plan beneficiaries and plans? Lastly, if the program is not all that it’s cracked up to be, what action should your plan take? We examine all these questions below. As a Spoiler Alert, we provide the following warning: The impact of Lilly’s and Express Scripts’ new program is contrary to what both entities claim. In fact, the program may actually harm your plan beneficiaries and your plan, not help them. How does the Lilly Program Actually Work? If you compare Lilly’s and Express Scripts’ press releases with Blink Health’s press release, the first thing you’ll notice is that Blink Health states that “everyone” has access to the new program: All anyone needs to do is sign onto Blink’s App, purchase and pay for any of Lilly’s three diabetes drugs based on a 40% discount, and thereafter pick up the discounted drugs at any of 67,000 pharmacies. If you cal Continue reading >>

Diabetes Advocates Protest At Eli Lilly About Insulin Prices

Diabetes Advocates Protest At Eli Lilly About Insulin Prices

On Saturday, September 9th, 2017 a group of diabetes patient advocates organized by T1International and People of Faith for Access to Medicines (PFAM) showed up in front of Eli Lilly’s Headquarters in Indianapolis, Indiana to protest rising insulin prices. Eli Lilly is one of the three top insulin manufacturers. The company markets Basaglar, Glucagon, Humalog, and other diabetes products. They are currently being sued in class action suit along with the other insulin makers, Sanofi and Novo Nordisk. T1International, an advocacy group who launched the initiative #insulin4all wrote on their blog that this protest was about those living with diabetes speaking up against the prices that ensure their survival. They want transparency about the costs associated with making insulin and the profits they make. They also want them to “commit to stopping the immoral act of price gouging people who depend on this medicine for survival.” Their specific requests to Eli Lilly: Be transparent about how much it costs to make one vial of Humalog insulin Be transparent about your profits from each vial Lower the price of insulin Involved in the protests were also parents of children with type 1 diabetes. One was Meri Schuhmacher-Jackson who blogs about life with 3 children with type 1 diabetes and commented on her reason for showing up to the protest: I went to the protest because I’m tired of doing nothing. It’s so easy to say, “This won’t change anything”…but certainly we must try. It turns out, there were newspapers there, there were radio stations there, and the story ended up on the front page of the Sunday paper. More people are made aware now than last week. I understand the entire world didn’t hear our cries…but if we’re lucky, the right person heard. We can Continue reading >>

Indianapolis #insulin4all Demonstration: Stop Price Gouging People With Diabetes!

Indianapolis #insulin4all Demonstration: Stop Price Gouging People With Diabetes!

WHAT: Demonstration in front of Eli Lilly and Company international corporate headquarters in downtown Indianapolis, Indiana. For more info and updates, join the Facebook event. WHEN: Saturday, September 9th at 1-3pm Can't make it to Indianapolis but want to do something? Join our online day of action on September 8th. WHY: People with diabetes are speaking out against the outrageous prices of a medication that is necessary for survival. We are asking Eli Lilly to be transparent about the costs of manufacturing insulin and the enormous profits it is making on the medicine, and to commit to stopping the immoral act of price gouging people who depend on this medicine for survival. Our asks to Eli Lilly are as follows: Be transparent about how much it costs to make one vial of Humalog insulin Be transparent about your profits from each vial Lower the price of insulin We have created some talking points for you in a PDF. BACKGROUND: Insulin, an essential medicine, was first used to treat a person with diabetes in 1922 and the discoverers intended it to be accessible for all. Now, almost 100 years later, the cost of insulin is increasingly unaffordable for people living with diabetes in the USA, causing people to ration insulin and skip injections. High prices are leading to bankruptcy and even death. Eli Lilly and Company is one of three manufacturers of insulin. In near lock-step with the other two manufacturers, Lilly has raised the price of its version of insulin by over 300% over the past seven years. A U.S. patient’s out-of-pocket cost for a month’s supply of Eli Lilly’s Humalog can be over $400. Although manufacturers like Eli Lilly keep the cost of insulin production a tightly-guarded secret, U.S. prices are likely hundreds of times higher than the expense of m Continue reading >>

Eli Lilly To Stop Producing Humulin®50/50 Insulin

Eli Lilly To Stop Producing Humulin®50/50 Insulin

After careful consideration, Eli Lilly and Company has decided to stop producing Humulin® 50/50. Use of this insulin has been declining and it is estimated that about 3000 patients nationwide will be impacted by this discontinuation. The insulin Humalog 50/50 is still available. Lilly’s first priority is to assist patients in transitioning as smoothly as possible to an alternate insulin therapy. Lilly is notifying HCPs regarding the timing for the discontinuation to allow affected patients sufficient time to transfer to alternate insulin formulations or treatments. Based on current patient demand and our current stock of Humulin 50/50, Lilly anticipates this insulin formulation should be available at pharmacies until the end of April 2010. All vials of Humulin 50/50 shipped before that date will now have the following notice printed on the carton, “Humulin 50/50 is being discontinued. Contact your physician to change to another insulin. For information, call 1-800-545-5979.” Continue reading >>

He Raised Drug Prices At Eli Lilly. Can He Lower Them For The U.s.?

He Raised Drug Prices At Eli Lilly. Can He Lower Them For The U.s.?

WASHINGTON — Alex M. Azar II, President Trump’s nominee to lead the Department of Health and Human Services, has expressed concern about the soaring cost of prescription drugs for many consumers. This week, Mr. Azar, a former pharmaceutical executive, is expected to face tough questions at a Senate confirmation hearing over why his own company raised prices. Democratic senators say that, as a top manager at Eli Lilly and Company, he was responsible for steep increases on insulin and other drugs. How he would now tackle that problem as secretary, along with the future of the Affordable Care Act, promises to dominate the hearings. Even Democrats who are unlikely to vote for Mr. Azar say that he will probably be confirmed, and that he would be more pragmatic and less ideological than the man he would succeed, Tom Price, who resigned in September under criticism for his use of private jets and military flights. And Mr. Azar has struck a conciliatory tone as the public outcry over pharmaceutical prices has grown. “Let’s start by saying, ‘We have a problem,’” he said at a pharmaceutical industry conference in May. Mr. Azar, 50, would bring an unusual combination of experience in government and industry to the job of running a cabinet department that spends more than a trillion dollars a year providing health insurance to more than 130 million Americans. His résumé is studded with conservative credentials. He was active in the Federalist Society and was a Supreme Court law clerk to Justice Antonin Scalia, whom he describes as “one of the 10 greatest figures in the history of Anglo-American law.” He spent two years working for Kenneth W. Starr, the independent counsel who investigated President Bill Clinton. He worked on the Bush-Cheney campaign in 2000 and Continue reading >>

Eli Lilly Tripled The Price Of Insulin Under Trump's Pick For Hhs And Democrats Are Pouncing On That

Eli Lilly Tripled The Price Of Insulin Under Trump's Pick For Hhs And Democrats Are Pouncing On That

President Donald Trump has said that Alex Azar, his pick for Health and Human Services secretary, will "be a star for better healthcare and lower drug prices." Some senators are using Azar's experience in the pharmaceutical industry to argue otherwise. In particular, Azar was a senior executive at Lilly during a time when the price of insulin steadily increased. Insulin prices rose three-fold during the period he was there, including when he served as president of the company, even though the medicine remained the same. Alex Azar, the new nominee for secretary of the Department of Health and Human Services, is being pitched as someone who will help lower the price of prescription drugs. "He will be a star for better healthcare and lower drug prices," President Donald Trump said in a tweet announcing Azar as his pick on Monday. Azar is Trump's choice to replace Tom Price, who resigned from the position in September after his use of private jets was reported to have cost taxpayers more than $1 million. Trump, who once said that drugmakers are "getting away with murder," has promised to get rising drug prices under control. But Azar's own track record with drug prices is giving Democrats fodder to attack the choice. Even though he's already served in the department that he's now being tapped to run, Azar was also a senior executive at Eli Lilly. Lilly is one of three companies that have substantially increased the price of insulin, the lifesaving drug used to treat diabetes. Some of those increases came while Azar was president of the company's US unit. The opposition was quick to point this out: Decade of price hikes Azar worked as HHS deputy secretary from 2005 to 2007 under President George W. Bush. In 2007, he joined the drugmaker Eli Lilly as a senior vice president o Continue reading >>

Hhs Nominee Alex Azar Takes Heat For Raising Insulin Prices

Hhs Nominee Alex Azar Takes Heat For Raising Insulin Prices

President Trump's nominee to lead the Department of Health and Human Services told senators Wednesday he would fight drug makers that try to block competition from generic companies, but took heat from Democrats for raising drug prices for insulin while he was a pharma CEO. Alex Azar was before the Senate Health, Education, Labor and Pensions Committee, which members of the committee used to remind Azar of his tenure as CEO of Eli Lilly's U.S. division, during which that company raised the price of insulin. Azar served as the head of Eli Lilly’s U.S. division from 2012 to 2017. During that time, the price of the Eli Lilly-made insulin drug Humalog rose from $122 for a vial in 2013 to $274 in 2017, according to the Indianapolis newspaper The Republic. Eli Lilly is part of a lawsuit filed earlier this year that charges the Indianapolis company of collusion with two other drugmakers to raise the price of insulin. Some senators called out Azar for that history during his hearing. "As a pharmaceutical executive, you raised drug prices year after year," said Sen. Patty Murray, D-Wash., the ranking member of the committee. Sen. Tammy Baldwin, D-Wis., said that drugmakers have a major role in pricing since they set the list price for the product. Azar responded that he favors insurance to ensure access to help pay for medications, but Baldwin said he was dodging the issue. "You pushed the blame on everybody else but pharmaceutical companies that set list prices," she said. Azar, who served as deputy director of HHS during the George W. Bush administration, criticized the way companies game the system, but had little defense for charges that he used it himself. “The system has the effects. That’s the problem,” he said. Insulin has been around since the 1920s, but no gene Continue reading >>

Insulin

Insulin

Indication BASAGLAR is a long-acting insulin used to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes. Limitation of Use BASAGLAR is not for treating diabetic ketoacidosis. Important Safety Information Do not take BASAGLAR during episodes of low blood sugar or if you are allergic to insulin glargine or any of the ingredients in BASAGLAR. Do NOT reuse needles or share insulin pens, even if the needle has been changed. Before starting BASAGLAR, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant, or if you are breastfeeding or planning to breastfeed. BASAGLAR should be taken once a day at the same time every day. Test your blood sugar levels while using insulin. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. The most common side effect of insulin, including BASAGLAR, is low blood sugar (hypoglycemia), which may be serious and life threatening. Signs and symptoms may include dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood change, or hunger. Do NOT dilute or mix BASAGLAR with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. BASAGLAR must only be used if the solution is clear and colorless with no particles visible. Always make sure you have the correct insulin before each injection. BASAGLAR may cause serious side effects that can lead to death, such as severe allergic reactions. Get emergency help if you have: Heart fa Continue reading >>

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