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Tag: Eli Lilly

  • FDA approves Wegovy pill for weight loss

    U.S. regulators on Monday gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity.The U.S. Food and Drug Administration’s approval handed drugmaker Novo Nordisk an edge over rival Eli Lilly in the race to market an obesity pill. Lilly’s oral drug, orforglipron, is still under review.Both pills are GLP-1 drugs that work like widely used injectables to mimic a natural hormone that controls appetite and feelings of fullness.Video above: Doctor’s perspective on making GLP-1s more affordableIn recent years, Novo Nordisk’s injectable Wegovy and Lilly’s Zepbound have revolutionized obesity treatment globally and in the U.S., where 100 million people have the chronic disease.The Wegovy pills are expected to be available within weeks, company officials said. Availability of oral pills to treat obesity could expand the booming market for obesity treatments by broadening access and reducing costs, experts said.About 1 in 8 Americans have used injectable GLP-1 drugs, according to a survey from KFF, a nonprofit health policy research group. But many more have trouble affording the costly shots.“There’s an entire demographic that can benefit from the pills,” said Dr. Fatima Cody Stanford, a Massachusetts General Hospital obesity expert. “For me, it’s not just about who gets it across the finish line first. It’s about having these options available to patients.”The Novo Nordisk obesity pill contains 25 milligrams of semaglutide. That’s the same ingredient in injectables Wegovy and Ozempic and in Rybelsus, a lower-dose pill approved to treat diabetes in 2019.In a clinical trial, participants who took oral Wegovy lost 13.6% of their total body weight on average over about 15 months, compared with a 2.2% loss if they took a placebo, or dummy pill. That’s nearly the same as injectable Wegovy, with an average weight loss of about 15%.Chris Mertens, 35, a pediatric lung doctor in Menomonee Falls, Wisconsin, joined the Novo Nordisk trial in 2022 and lost about 40 pounds using the Wegovy pill. The daily medication worked to decrease his appetite and invasive thoughts of food, he said.“If there were days where I missed a meal, I almost didn’t realize it,” Mertens said.Participants in a clinical trial who took the highest dose of Lilly’s orforglipron lost 11.2% of their total body weight on average over nearly 17 months, compared with a 2.1% loss in those who took a placebo.Both pills resulted in less weight loss than the average achieved with Lilly’s Zepbound, or tirzepatide, which targets two gut hormones, GLP-1 and GIP, and led to a 21% average weight loss.All the GLP-1 drugs, oral or injectable, have similar side effects, including nausea and diarrhea.Both daily pills promise convenience, but the Wegovy pill must be taken with a sip of water in the morning on an empty stomach, with a 30-minute break before eating or drinking.That’s because Novo Nordisk had to design the pill in a way that prevented the drug from being broken down in the stomach before it could be absorbed by the bloodstream. The drugmaker added an ingredient that protects the medication for about 30 minutes in the gut and makes it easier to take effect.By contrast, Lilly’s orforglipron has no dosing restrictions. That drug is being considered under the FDA’s new priority voucher program aimed at cutting drug approval times. A decision is expected by spring.Producing pills is generally cheaper than making drugs delivered via injections, so the cost for the new oral medications could be lower. The Trump administration earlier this year said officials had worked with drugmakers to negotiate lower prices for the GLP-1 drugs, which can cost upwards of $1,000 a month.The company said the starting dose would be available for $149 per month from some providers. Additional information on cost will be available in January.It’s not clear whether daily pills or weekly injections will be preferred by patients. Although some patients dislike needles, others don’t seem to mind the weekly injections, obesity experts said. Mertens turned to injectable Zepbound when he regained weight after the end of the Wegovy pill clinical trial.He said he liked the discipline of the daily pill.“It was a little bit of an intentional routine and a reminder of today I’m taking this so that I know my choices are going to be affected for the day,” he said.Dr. Angela Fitch, an obesity expert and chief medical officer of knownwell, a health care company, said whatever the format, the biggest benefit will be in making weight-loss medications more widely accessible and affordable.“It’s all about the price,” she said. “Just give me a drug at $100 a month that is relatively effective.”

    U.S. regulators on Monday gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity.

    The U.S. Food and Drug Administration’s approval handed drugmaker Novo Nordisk an edge over rival Eli Lilly in the race to market an obesity pill. Lilly’s oral drug, orforglipron, is still under review.

    Both pills are GLP-1 drugs that work like widely used injectables to mimic a natural hormone that controls appetite and feelings of fullness.

    Video above: Doctor’s perspective on making GLP-1s more affordable

    In recent years, Novo Nordisk’s injectable Wegovy and Lilly’s Zepbound have revolutionized obesity treatment globally and in the U.S., where 100 million people have the chronic disease.

    The Wegovy pills are expected to be available within weeks, company officials said. Availability of oral pills to treat obesity could expand the booming market for obesity treatments by broadening access and reducing costs, experts said.

    About 1 in 8 Americans have used injectable GLP-1 drugs, according to a survey from KFF, a nonprofit health policy research group. But many more have trouble affording the costly shots.

    “There’s an entire demographic that can benefit from the pills,” said Dr. Fatima Cody Stanford, a Massachusetts General Hospital obesity expert. “For me, it’s not just about who gets it across the finish line first. It’s about having these options available to patients.”

    The Novo Nordisk obesity pill contains 25 milligrams of semaglutide. That’s the same ingredient in injectables Wegovy and Ozempic and in Rybelsus, a lower-dose pill approved to treat diabetes in 2019.

    In a clinical trial, participants who took oral Wegovy lost 13.6% of their total body weight on average over about 15 months, compared with a 2.2% loss if they took a placebo, or dummy pill. That’s nearly the same as injectable Wegovy, with an average weight loss of about 15%.

    Chris Mertens, 35, a pediatric lung doctor in Menomonee Falls, Wisconsin, joined the Novo Nordisk trial in 2022 and lost about 40 pounds using the Wegovy pill. The daily medication worked to decrease his appetite and invasive thoughts of food, he said.

    “If there were days where I missed a meal, I almost didn’t realize it,” Mertens said.

    Participants in a clinical trial who took the highest dose of Lilly’s orforglipron lost 11.2% of their total body weight on average over nearly 17 months, compared with a 2.1% loss in those who took a placebo.

    Both pills resulted in less weight loss than the average achieved with Lilly’s Zepbound, or tirzepatide, which targets two gut hormones, GLP-1 and GIP, and led to a 21% average weight loss.

    All the GLP-1 drugs, oral or injectable, have similar side effects, including nausea and diarrhea.

    Both daily pills promise convenience, but the Wegovy pill must be taken with a sip of water in the morning on an empty stomach, with a 30-minute break before eating or drinking.

    That’s because Novo Nordisk had to design the pill in a way that prevented the drug from being broken down in the stomach before it could be absorbed by the bloodstream. The drugmaker added an ingredient that protects the medication for about 30 minutes in the gut and makes it easier to take effect.

    By contrast, Lilly’s orforglipron has no dosing restrictions. That drug is being considered under the FDA’s new priority voucher program aimed at cutting drug approval times. A decision is expected by spring.

    Producing pills is generally cheaper than making drugs delivered via injections, so the cost for the new oral medications could be lower. The Trump administration earlier this year said officials had worked with drugmakers to negotiate lower prices for the GLP-1 drugs, which can cost upwards of $1,000 a month.

    The company said the starting dose would be available for $149 per month from some providers. Additional information on cost will be available in January.

    It’s not clear whether daily pills or weekly injections will be preferred by patients. Although some patients dislike needles, others don’t seem to mind the weekly injections, obesity experts said. Mertens turned to injectable Zepbound when he regained weight after the end of the Wegovy pill clinical trial.

    He said he liked the discipline of the daily pill.

    “It was a little bit of an intentional routine and a reminder of today I’m taking this so that I know my choices are going to be affected for the day,” he said.

    Dr. Angela Fitch, an obesity expert and chief medical officer of knownwell, a health care company, said whatever the format, the biggest benefit will be in making weight-loss medications more widely accessible and affordable.

    “It’s all about the price,” she said. “Just give me a drug at $100 a month that is relatively effective.”

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  • Novo cuts Wegovy prices, but doctors still see cost challenges for patients

    Novo Nordisk is chopping prices again for Wegovy, but doctors say the expense will remain challenging for patients without insurance.

    The drugmaker said Monday that it has started selling higher doses of the injectable obesity treatment for $349 a month to patients paying the full bill. That’s down from $499, and in line with terms of a drug pricing agreement outlined earlier this month by President Donald Trump’s administration.

    Novo also started a temporary offer of $199 a month for the first two months of low doses of Wegovy and the drug’s counterpart for diabetes, Ozempic. The new pricing will be available at pharmacies nationwide, through home delivery and from some telemedicine providers.

    Rival Eli Lilly also plans price breaks for its weight-loss drug Zepbound once it gets a new, multi-dose pen on the market. Lilly has said it will sell a starter dose of Zepbound for $299 a month and additional doses at up to $449. Both represent $50 reductions from current prices for sales directly to patients.

    Obesity treatments like Zepbound and Wegovy have soared in popularity in recent years. Known as GLP-1 receptor agonists, the drugs work by targeting hormones in the gut and brain that affect appetite and feelings of fullness.

    In clinical trials, they helped people shed 15% to 22% of their body weight — up to 50 pounds or more in many cases. But affordability has been a persistent challenge for patients.

    A recent poll by the nonprofit KFF found that about half of the people who take the treatments say it was hard to afford them.

    Both Lilly and Novo announced price cuts earlier this year that brought the cost of higher doses of their treatments down to around $500 a month.

    Previous research has shown that people have difficulty paying for a medication when the cost rises above $100 per month, said Stacie Dusetzina, a Vanderbilt University Medical Center professor and prescription drug pricing expert.

    She said Novo’s new prices are “not going to really move the needle for a person who doesn’t have a pretty reasonable amount of disposable income.”

    Dr. Laura Davisson said the medication would still be unaffordable for patients on Medicaid in states where the government-funded program for people with low incomes doesn’t cover the drug.

    The bigger issue is expanding coverage of the treatments, said Davisson, a West Virginia University obesity specialist.

    “We’ve had hundreds of people lose coverage over the last couple of years, and we keep seeing more and more insurers drop coverage,” she said, adding that her practice has started a group support program to help those who have lost coverage.

    Coverage is slated to improve starting next year for at least one big payer under a deal announced by the Trump administration. The federally funded Medicare program, mainly for people ages 65 and older, will begin covering the treatments for people who have severe obesity and others who are overweight or obese and have serious health problems.

    Those who qualify will pay $50 copays for the medicine.

    Administration officials also said lower prices for the drugs that they negotiated for Medicare also will be provided for Medicaid programs.

    That will help expand coverage, according to Dave Moore, Novo’s executive vice president for U.S. operations. He said Medicaid programs in 20 states cover the drug for obesity.

    Novo officials expect around 40 million more Americans will gain access to their drug through coverage expansions for Medicaid and Medicare.

    Neither Moore nor representatives for Eli Lilly would say whether they plan additional price cuts. Both companies also are seeking approval of pill versions of the drugs, which would come with new prices.

    Lilly spokesperson Courtney Kasinger said the company believes obesity treatments should be covered just like those for any other chronic condition.

    “We’re going to continue to work to improve coverage as much as we can across all channels, all stakeholders,” she said.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • Eli Lilly to invest $5B on new Virginia manufacturing facility – WTOP News

    Indianapolis-based pharmaceutical giant Eli Lilly confirms plans to build a $5 billion manufacturing facility just west of Richmond, Virginia.

    Indianapolis-based pharmaceutical giant Eli Lilly confirms plans to build a $5 billion manufacturing facility just west of Richmond, Virginia. (Courtesy Eli Lilly)

    Indianapolis-based pharmaceutical giant Eli Lilly confirmed plans to build a $5 billion manufacturing facility just west of Richmond, Virginia, in Goochland County, and create 1,800 construction jobs as well as another 650 high-paying science and engineering positions within the next five years.

    Lilly chose Goochland County from hundreds of applications based on several criteria, including workforce potential in the Richmond area, local incentives, ready access to utilities, transportation and favorable zoning. Lilly is receiving job creation support through the Virginia Talent Accelerator Program, created by the Virginia Economic Development Partnership, in collaboration with higher education partners.

    Any financial support from the state was not disclosed.

    The facility, the first of four new facilities it will announce in the U.S. this year, will be its first dedicated, fully integrated active pharmaceutical ingredient and drug product facility for its emerging bioconjugate platform and monoclonal antibody portfolio.

    At the Richmond-area site, it will also boost its domestic manufacturing of antibody-drug conjugates, or ADCs, a targeted therapy designed to deliver potent medicines directly to diseased cells. They act like highly-specialized carriers, maximizing treatment effectiveness while reducing harm to healthy tissue.

    ADCs are currently primarily used to treat cancer but are being explored for autoimmune diseases and other conditions.

    Lilly said it expects that for every dollar invested in the Virginia facility, up to four dollars will be generated in local economic activity, and each manufacturing job will support multiple positions in related industries, such as supply chain, logistics and retail.

    Lilly will also engage locally, partnering with area universities and supporting community education initiatives in Virginia.

    Lilly will announce its three other new U.S. facilities before the end of this year, and expects to begin making medicines at them within five years.

    Eli Lilly announced in February it would spend at least $27 billion to build new U.S. manufacturing plants, adding to $23 billion previous investments since 2020. It is among drugmakers moving to boost U.S. production on President Donald Trump’s warning to clamp down on pharmaceutical imports with steep tariffs.

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    Jeff Clabaugh

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  • Eli Lilly to Build $5 Billion Drug Manufacturing Plant in Virginia

    Eli Lilly announced plans on Tuesday to build a $5 billion drug manufacturing facility in Virginia. The announcement comes amid pressure from President Donald Trump to bring more drug manufacturing to the U.S. and threats to slap heavy tariffs on pharmaceuticals coming from overseas.

    The new manufacturing plant will be built west of Richmond, Virginia, in Goochland County, according to a press release from the company. Eli Lilly says it expects the project to be completed in five years and claims it will bring “more than 650 new high-paying jobs to Virginia, including highly skilled engineers, scientists, operations personnel and lab technicians.”

    Eli Lilly’s press release included a statement from Virginia Gov. Glenn Youngkin, who also noted the number of construction jobs that would be brought to the state.

    “Lilly is one of the world’s great innovators, and I want to thank them for this significant commitment to Virginia,” said Youngkin. “This new facility in Goochland County will create 650 great jobs, along with 1,800 construction jobs, and deliver some of the most advanced medicines in Lilly’s portfolio, powered by the unmatched talent of our Virginia workforce.”

    Youngkin, a Republican, touted the benefits to the U.S. supply chain, something that was severely disrupted during the covid-19 pandemic, leading to calls to bring more drug manufacturing to the U.S.

    “By expanding manufacturing capacity here in the United States, we are strengthening our economy, securing America’s critical pharmaceutical supply chain, and positioning Virginia to lead in the industries that will drive innovation for generations to come,” said Yougkin.

    Lilly first announced back in February that it would be investing over $27 billion into new manufacturing facilities, bringing its total investments to $50 billion since 2020. The company said Tuesday that three other U.S. manufacturing sites would be announced soon. All four sites are expected to be making pharmaceuticals within five years, according to the company.

    “This isn’t just another manufacturing site—it represents a significant milestone for Lilly, as we begin building our first bioconjugate facility,” said Edgardo Hernandez, executive vice president and president of Lilly Manufacturing Operations, in a press release.

    “With this cutting-edge site, Lilly is setting a new benchmark in bioconjugate innovation, advancing technologies that will expand what’s possible for patients,” Hernandez continued. “This investment reflects our bold vision, our commitment to transformative technologies and our dedication to being a good neighbor through sustainability efforts and support of local education and community partnerships.”

    Trump initially threatened in July to impose tariffs of 200% on prescription drugs coming from overseas, though the number floated in August jumped around from between 150% to 250%, according to CNBC. At the time, Trump said he would start to impose that tariff in a year or a year and a half, though the president is known to move deadlines forward and backward on a whim.

    Aside from trying to bring drug manufacturing to the U.S., President Trump has also attempted to press drug companies into lowering prices, though he seems to have had less luck with trying to make that happen simply by decree.

    Matt Novak

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  • Next Gen Weight Loss Drugs Are Coming for Ozempic’s Throne

    Next Gen Weight Loss Drugs Are Coming for Ozempic’s Throne

    The future of weight loss is fast approaching. At a recent scientific conference, drug companies showed off a variety of next-generation drugs for both obesity and type 2 diabetes. Some of these treatments might help people lose even more weight than current forerunners like Novo Nordisk’s semaglutide—the active ingredient in popular drugs Ozempic and Wegovy—while others may come with fewer side effects or be easier to take.

    Semaglutide is a drug that mimics GLP-1, one of several hormones that help regulate our sense of hunger and blood sugar. In clinical trials, semaglutide has proven to be much more effective at treating obesity than diet and exercise alone. Previously only approved for type 2 diabetes as Ozempic, semaglutide was approved for obesity in 2021 under the name Wegovy. However, it’s already started to be overshadowed by the arrival of Eli Lilly’s tirzepatide, which combines GLP-1 with another incretin hormone called GIP. Tirzepatide was approved by the Food and Drug Administration in 2021 for type 2 diabetes under the brand name Mounjaro; in November 2023, it was approved to treat obesity as Zepbound.

    Newer treatments in the works are poised to compete with and possibly surpass both of these drugs. The American Diabetes Association held its annual conference over the past weekend, and the emergence of these future medications was a big aspect of the event. Companies presented preliminary data on over two dozen GLP-1 related drugs, all in various stages of development.

    “We’ve heard about Ozempic and Mounjaro and so on, but now we’re seeing lots and lots of different drug candidates in the pipeline, from very early-stage preclinical all the way through late-stage clinical,” Marlon Pragnell, ADA’s vice president of research and science, told NBC News. “It’s very exciting to see so much right now.”

    Altimmune’s pemvidutide, for instance, combines GLP-1 with glucagon, another hormone key to keeping our blood sugar level stable. In Phase II trial data presented this weekend, pemvidutide was found to help people lose over 15% of their baseline weight within 48 weeks, a bit ahead of the pace seen with semaglutide (15% weight loss over 68 weeks). A dual GLP-1/GIP candidate developed by scientists in China, called HRS9531 for now, was found to cause up to 16% weight loss within 24 weeks. Eli Lilly also presented new data on its second-generation drug retatrutide, which combines GLP-1, GIP, and glucagon, finding it improved insulin’s ability to control blood sugar in people with type 2 diabetes. In previous research, retatrutide was found to cause up to 24% weight loss, the highest mark seen yet with these drugs.

    It’s not certain that these or other GLP-1 drugs in development will truly outmatch semaglutide and tirzepatide in terms of weight loss, but they may still have other benefits over them. Pemvidutide was found to cause less lean body mass loss, for instance, possibly due to the addition of glucagon (exercise naturally raises glucagon levels, so the drug could be mimicking some of the positive effects of exercise). Some experts are skeptical that lean body mass loss is a major concern with these drugs. However, it may be important to prevent this in individuals who are more vulnerable to muscle or bone loss, such as older adults.

    It will take years for these newer drugs to reach the public, assuming they continue to succeed in larger trials. Their arrival may not only help people who don’t respond to existing treatments, though, but could also drive down the overall high costs of these medications (without insurance coverage, which is often denied, a month’s supply of semaglutide can reach over $1,000 per month).

    “Over the past few years, we have seen the substantial impact of new research working to solve the dual health crisis we are facing, obesity and diabetes,” said Robert Gabbay, chief scientific and medical officer for the ADA, in a statement from the ADA. “The studies we are seeing presented at this year’s annual meeting show great promise to fuel new solutions and treatment options for patients across the globe living with type 2 diabetes and obesity.”

    Ed Cara

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  • Drugmakers hiking prices for more than 700 medications, including Ozempic and Mounjaro

    Drugmakers hiking prices for more than 700 medications, including Ozempic and Mounjaro

    Fighting rising prescription drug costs


    Fighting rising prescription drug costs

    07:59

    Pharmaceutical companies are hiking prices for more than 700 medications, including popular weight-loss drugs Ozempic and Mounjaro, industry research shows.

    The average price increase at year start was about about 4.5%, the analysis from 46 Brooklyn found. That represents a slightly slower pace compared with the five prior years, when drug prices rose about 5% each year on average, the data shows. 

    Among the noteworthy increases are Ozempic and Mounjaro, two drugs that belong to a class of medications called GLP-1 agonists. While these drugs are designed to help diabetics regulate their blood sugar, they’ve also been found to be effective weight-loss drugs, prompting non-diabetics to seek out the drugs in order to slim down. As a result, these drugs have been in greater demand, leading to shortages

    The price of Ozempic, which is manufactured by Novo Nordisk, rose 3.5% to $984.29 for a month’s supply, while Eli Lilly’s Mounjaro rose 4.5% to about $1,000 for a month’s worth of the medication, the 46 Brooklyn data shows.

    Eli Lilly didn’t immediately return a request for comment. In a statement to CBS MoneyWatch, Novo Nordisk said that it “increases the list price of some of our medicines each year in response to changes in the health care system, market conditions and the impact of inflation.”

    Prices are increasing this year for many other widely used drugs:

    • Autoimmune disease medication Enbrel rose 5%
    • Pain medication Oxycontin rose 9%
    • Blood thinner Plavix rose 4.7%
    • Antidepressant Wellbutrin rose 9.9%

    “Technically, most brand prescription drug list price increases occur in either January or July each year, but the greatest number take place in January (and thus, January gets all the attention),” 46 Brooklyn wrote in a blog post about the drug increases. “By our counts, since 2018, more than 60% of all brand drug list price increases that occur throughout the course of each year are implemented in the month of January.”

    46 Brooklyn’s analysis may not reflect what a patient ultimately pays for a drug. Their analysis is based on the wholesale acquisition cost, which is the price that drugmakers charge to wholesalers that distribute the drugs to pharmacies. Patients may pay less due to insurance coverage as well as rebates and other discounts.

    Novo Nordisk said its list price isn’t representative of what most insured patients pay out of pocket. “That’s because after we set the list price, we negotiate with the companies that pay for our medicines (called payers) to ensure our products remain on their formularies so patients have access to our medicines,” the company said. “These payers then work directly with health insurance companies to set prices and co-pay amounts.”

    Where drug prices are dropping

    Not all medications saw price hikes, with the analysis finding that about two dozen medications dropped sharply in price at year start, including some popular insulin products. The high cost of insulin has drawn attention from the Biden administration and health policy experts, with the Human Rights Watch terming its pricing in the U.S. as a human rights violation. 

    The decline in insulin prices comes after Medicare, the insurance program for people 65 and older, capped the monthly price of insulin at $35. That prompted some drugmakers to slash the cost of insulin for a broader group of patients. The price of Novo Nordisk insulin products, sold under the Novolog brand name, declined 75% compared with a year earlier, the analysis found. 

    Other medications that saw price cuts include:

    • Erectile dysfunction drug Cialis dropped 19%
    • Antidepressant Prozac declined 18%
    • Chronic obstructive pulmonary disease medication Advair declined 22% to 60%, depending on the formulation

    While the decreases impact a small number of drugs compared with the hundreds that saw price hikes, they are nevertheless “truly remarkable from a historical perspective,” 46 Brooklyn noted. 

    “This phenomenon is particularly noteworthy due to the nature of the drugs that underwent decreases, primarily comprising historically high-utilization products such as insulins, asthma/COPD inhalers, and central nervous system (CNS) drugs,” the group noted.

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  • Isomorphic inks deals with Eli Lilly and Novartis for drug discovery | TechCrunch

    Isomorphic inks deals with Eli Lilly and Novartis for drug discovery | TechCrunch

    Isomorphic Labs, the London-based, drug discovery-focused spin-out of Google AI R&D division DeepMind, today announced that it’s entered into strategic partnerships with two pharmaceutical giants, Eli Lilly and Novartis, to apply AI to discover new medications to treat diseases.

    The deals have a combined value of around $3 billion. Isomorphic will receive $45 million upfront from Eli Lilly and potentially up to $1.7 billion based on performance milestones, excluding royalties. Novartis, meanwhile, will pay $37.5 million upfront in addition to funding “select” research costs and as much as $1.2 billion (once again excluding royalties) in performance-based incentives over time.

    “We’re thrilled to embark on this partnership and apply our proprietary technology platform,” DeepMind co-founder and Isomorphic CEO Demis Hassabis was quote as saying in a press release. “The focus we share on advancing groundbreaking drug design approaches and appreciation of state-of-the-art science makes [these] partnership[s] particularly compelling.”

    Fiona Marshall, president of biomedical research at Novartis, added in a statement: “Cutting-edge AI technologies … hold the potential to transform how we discover new drugs and accelerate our ability to deliver life-changing medicines for patients. This collaboration harnesses our companies’ unique strengths, from AI and data science to medicinal chemistry and deep disease area expertise, to realize new possibilities in AI-driven drug discovery.”

    Isomorphic, which Hassabis launched in 2021 under DeepMind parent company Alphabet, draws on DeepMind’s AlphaFold 2 AI technology that can be used to predict the structure of proteins in the human body. By uncovering these structures, the hope is that researchers can identify new target pathways to deliver drugs for fighting disease.

    The tech isn’t perfect. A recent article in the journal Nature pointed out that AlphaFold occasionally makes obvious mistakes and, in many cases, is more useful as a “hypothesis generator” rather than a replacement for experimental data. But the scale at which the model can generate reasonably accurate protein predictions is beyond most methods that came before.

    Researchers recently used AlphaFold to design and synthesize a potential drug to treat hepatocellular carcinoma, the most common type of primary liver cancer. And DeepMind is collaborating with Geneva-based Drugs for Neglected Diseases initiative, a nonprofit pharmaceutical organization, to apply AlphaFold to formulating therapeutics for Chagas disease and Leishmaniasis, two of the most deadly diseases in the developing world.

    The latest version of AlphaFold can generate predictions for nearly all molecules in the Protein Data Bank, the world’s largest open access database of biological molecules, DeepMind announced in October. The model can also accurately predict the structures of ligands — molecules that bind to “receptor” proteins and cause changes in how cells communicate — as well as nucleic acids (molecules that contain key genetic information) and post-translational modifications (chemical changes that occur after a protein’s created).

    Already, Isomorphic is applying the new AlphaFold model — which it co-designed with DeepMind — to therapeutic drug design, helping to characterize different types of molecular structures important for treating disease.

    The pressure’s on for Isomorphic to start generating a profit. In 2021, the company recorded a £2.4 million (~$3 million) loss as it ramped up hiring ahead of opening its second office location in Lausanne, Switzerland.

    Kyle Wiggers

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  • Are You Sure You Want an Ozempic Pill?

    Are You Sure You Want an Ozempic Pill?

    Within the first five seconds of a recent Ozempic commercial, a sky-blue injector pen tumbles toward the viewer, encircled by a big red O. Obesity drugs have become so closely associated with injections that the two are virtually synonymous. Like Ozempic, whose name is now a catchall term for obesity drugs, Wegovy and Zepbound come packaged in Sharpie-like injection pens that patients self-administer once a week. Patients “don’t come in asking for Wegovy,” Laura Davisson, a professor of medical weight management at West Virginia University, told me. “They come in asking for one of ‘those injectables.’”

    Needles are the present, but supposedly not the future. Nobody really likes injections, and taking a pill would be far easier. In the frenzy over obesity drugs, a class known as GLP-1 agonists, drugmakers have raced to create them in pill form, and Wall Street investors are hungry at the prospect. Earlier this year, Pfizer’s CEO, Albert Bourla, estimated that obesity pills could be worth $30 billion, or a third of the total obesity-drug market. Because people have a “preference” for pills, he said at a conference, they will be what ultimately “unlocks the market” for obesity medications. By one count, at least 32 oral GLP-1 drugs, from many different companies, are in the works.

    But a future dominated by obesity pills is hardly certain. So far, the only oral GLP-1 that exists is a pill for diabetes called Rybelsus. Like Ozempic and Wegovy, its active ingredient is a compound called semaglutide, but the shots come in far more powerful doses, making it possible to lose even more weight. Developing oral obesity drugs that are as tolerable and effective as their injectable counterparts has so far been a challenge. Earlier this month, Pfizer stopped testing one of its pill candidates, citing concerns about side effects and patient adherence. Even when pills do come to market, doctors told me, there’s no guarantee that people will flock to them.

    That drugmakers view the injectable nature of GLP-1s as one of their biggest flaws is no surprise. Getting a shot is a broadly despised experience, something people generally tolerate rather than choose. Children get stickers for enduring immunizations; adults who get vaccinated do so only because they must (and they are often rewarded with stickers too). The CDC estimates that one in four adults, and two out of three children, have strong fears about needles. “Some people hate needles, plain and simple,” Ted Kyle, an obesity-policy expert, told me.

    But not all needles are made equal. Wegovy and Zepbound are injected subcutaneously, or just under the skin. Relative to COVID or flu shots, which are jabbed into muscle, they don’t cause much discomfort. “I’ve been really surprised at how receptive my patients have been to using injectable medications,” Davisson said. Other doctors I spoke with agreed. “More patients than you would expect really don’t mind injectables,” because they’re easy and relatively painless to administer, Katherine Saunders, a clinical-medicine professor at Weill Cornell Medicine, told me.

    The unobtrusive dosing schedule of the injectables adds to their appeal. Wegovy and Zepbound are administered once weekly, unlike many of the pills in development, which are meant to be taken once or more daily. That can be a hassle, especially if they have to be taken at the same time every day, or if they come with restrictions on eating or drinking. “For some people, it’s easier to take an injection and forget about it for a week” than to remember to take a pill every day, Eduardo Grunvald, an obesity-medicine physician at UC San Diego Health, told me. Assuming pills are preferable to shots is a “knee-jerk reaction,” he added.

    Despite the unexpected upsides of the shots, they’re far from perfect. Making injectable pens is generally more expensive than pills and requires a lot of hardware, including the pen casing, cap, and needle cover. On top of that, the injectable obesity drugs must be refrigerated before they are first used, adding to storage and production costs. Pills are generally shelf-stable and don’t require much packaging beyond a child-proof bottle. Saunders predicts they would be less expensive and less prone to shortages that have plagued Wegovy.

    Still, creating an obesity pill isn’t as simple as packaging the same drugs in capsule form. Drugmakers have already run into a number of issues. Absorption is a big one: Because pills pass through the stomach before entering the bloodstream, they must be able to withstand a large degree of degradation. One way to get these drugs to lead to greater weight loss is to increase the dose. While the highest dose of Wegovy is 2.4 milligrams, Rybelsus maxes out at 14 milligrams.

    Hiking up the dose seems to work, though doing so could have consequences beyond weight loss. All GLP-1 drugs come with a range of unpleasant side effects involving the gastrointestinal system, and patients report nausea at similar rates in Rybelsus and Ozempic, according to the FDA. But this may differ in practice, as other doctors have noted. Saunders said that her patients on oral semaglutide report more nausea than those using injectables. Regardless, newer oral medications may have even more distinct differences, as drugmakers race to create more potent pills. In Pfizer’s discontinued trial of danuglipron, nausea rates reached up to 73 percent.

    Drugmakers also skirt the issue of degradation by pursuing sturdier drugs. The problem with semaglutide is that it’s a peptide—essentially a small protein—precisely the kind of molecule that the stomach excels at digesting. Some new drugs in the pipeline are so-called non-peptide small molecules, which are sturdier but still have the same biological effect. Orforglipron, a pill that Eli Lilly is testing, falls into this category, as does danuglipron, the drug responsible for Pfizer’s recent setbacks. Small-molecule drugs have the added benefit of being cheaper to produce at scale than peptides, Kyle, the obesity-policy expert, added.

    Another pesky problem with oral drugs is that they tend to come with strict dosing requirements. People on Rybelsus, for example, are instructed to take it 30 minutes before eating or drinking anything and can drink only four ounces of plain water along with it, because otherwise absorption could be compromised. “It can be a nuisance,” Grunvald said. Similarly bothersome instructions likely played a part in the drop-out rates reaching more than 50 percent in Pfizer’s recently discontinued trial: Danuglipron had to be taken twice daily. “A lot of people found it not worth the trouble,” Kyle said, noting that Pfizer is still pursuing a once-daily version of the same drug. A recent review of GLP-1 drugs showed that, compared with the injectable form, oral semaglutide is associated with lower rates of side-effect reporting but higher discontinuation rates, potentially reflecting its bothersome dosage requirements.

    Despite these hurdles, it seems inevitable that obesity-drug pills will eventually become available. Novo Nordisk is expected to file for FDA approval for its high-dose semaglutide obesity pill this year; Pfizer is forging ahead with a once-daily version of danuglipron, with more data expected “in the first half of 2024,” a spokesperson told me. A report from BMO Equity Research published in September predicted that oral formulations could be approved “by the late 2020s.” The biggest upside to pills may not be that they are pills but that they will, eventually, be cheaper than injectables—and cost is among the biggest impediments to more people taking obesity drugs.

    Whether they’ll replace injectables outright is far from certain. “It will come down to patient preference,” Grunvald said. Most likely, pills and injections will coexist to meet different needs, and perhaps even be used together to treat individual patients. In the so-called phased approach, obesity treatment could start with more expensive and powerful injectable drugs, then transition to less potent but cheaper orals for the long term. Eli Lilly, for one, sees its oral candidate, orforglipron, as a potential weight-loss-maintenance drug.

    There is so much competition in the obesity-drug space that future medications may take more unexpected forms. Amgen is studying a once-monthly injection; Novo Nordisk is developing a hydrogel form of semaglutide that would need to be taken only three times a year. If the future of obesity drugs will come down to what patients prefer, then the more options, the better.

    Yasmin Tayag

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  • The U.S. Food and Drug Administration approves Eli Lilly’s Zepbound drug for weight loss

    The U.S. Food and Drug Administration approves Eli Lilly’s Zepbound drug for weight loss

    The U.S. Food and Drug Administration approves Eli Lilly’s Zepbound drug for weight loss – CBS News


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    The FDA has approved Eli Lilly’s Zepbound drug for weight loss. It’s set to hit the market by the end of the year. Nancy Chen has more.

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  • FDA approves a new weight loss drug, Zepbound from Eli Lilly

    FDA approves a new weight loss drug, Zepbound from Eli Lilly

    The Food and Drug Administration approved a request by Eli Lilly on Wednesday to begin marketing its tirzepatide medication, which is branded as Mounjaro for diabetes, under a new brand for weight loss as well.

    While Mounjaro had already been used by some patients “off-label” for weight loss, the new FDA approval will allow the drugmaker to begin officially selling and marketing tirzepatide — branded as Zepbound — for weight loss too.

    Zepbound will be available for patients in the U.S. by the end of the year, the drugmaker said.

    The company said Wednesday in a news release that the medication will be sold at a cheaper list price than its semaglutide competitors from Novo Nordisk, which are branded as Wegovy for weight loss and Ozempic for diabetes. 

    “New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management,” Joe Nadglowski, CEO of the Obesity Action Coalition, said in Eli Lilly’s release. The group receives funding from Eli Lilly and other pharmaceutical and health care companies.

    The FDA’s approval of Zepbound was partially based on a trial of adults without diabetes, which found that participants — who averaged 231 pounds at the start of the trial — who were given the highest approved dose lost around 18% of their body weight compared to placebo.

    “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need,” the FDA’s Dr. John Sharretts, director of the agency’s Division of Diabetes, Lipid Disorders, and Obesity, said in a news release.

    While there have not been results from large clinical trials comparing Novo Nordisk’s and Eli Lilly’s medications head-to-head, there is some research to suggest Zepboud could outperform Ozempic

    A meta-analysis presented at the annual meeting of the European Association for the Study of Diabetes in October concluded tirzepatide was “more effective for weight loss than semaglutide, with a larger weight-loss effect at higher doses,” but acknowledged limitations in trying to make a direct comparisons of the two.

    In a report earlier this year comparing semaglutide and tirzepatide for diabetics, the Institute for Clinical and Economic Review concluded that tirzepatide showed “greater reduction” in weight and other key markers, but “had a greater incidence of gastrointestinal side effects, severe adverse events, and discontinuation compared with semaglutide.”

    Zepbound carries the risk of an array of potential side effects, the FDA says, including nausea, diarrhea, vomiting, constipation, and hair loss. 

    Like with other weight loss drugs in this class, some of Zepbound’s side effects could be serious.  

    People with a history of severe gastroparesis, or stomach paralysis, should not use the drug, the FDA says. 

    Eli Lilly and Novo Nordisk have both faced claims that their drugs can cause stomach paralysis. The FDA recently moved to acknowledge reports of ileus, or a blockage in the intestines, on Ozempic’s label.

    The agency also notes that other people could be at higher risk of more severe issues from Zepbound, including patients with a history of medullary thyroid cancer, pancreas inflammation, or severe gastrointestinal disease.

    It also should not be combined with other so-called GLP-1 receptor agonist drugs, which include its sibling Mounjaro, as well as Wegovy and Ozempic. 

    “The safety and effectiveness of coadministration of Zepbound with other medications for weight management have not been established,” the agency says.

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  • Is This Premenstrual Condition a Mental Illness or Oppression?

    Is This Premenstrual Condition a Mental Illness or Oppression?

    This article originally appeared in Undark Magazine.

    For one week of every month, I have a very bad time. My back aches so badly I struggle to stand up straight. My mood swings from frantic to bleak. My concentration flags; it’s difficult to send an email. Then, my period starts, and the curse is lifted. I feel okay again.

    Like some 1 to 7 percent of menstruating women, I meet the criteria for premenstrual dysphoric disorder, or PMDD. According to the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR), a person with PMDD experiences marked emotional changes—such as sadness, anger, or anxiety—and physical or behavioral changes—such as difficulty concentrating, fatigue, or joint pain—in the week before their period. PMDD can also affect trans men and nonbinary people who menstruate.

    When I first heard of PMDD, it was a revelation. Here was a concrete explanation for the pain and stress I was feeling every month. Better yet, there was a simple, effective treatment: common antidepressant drugs called selective serotonin reuptake inhibitors, or SSRIs, which can be prescribed for people to take only in the two weeks before their period. Birth-control pills, cognitive behavioral therapy, and calcium supplements may also help.

    Then I heard about the controversy surrounding the diagnosis. When the American Psychiatric Association added a form of PMDD as a proposed disorder to the diagnostic manual in the 1980s—DSM-III-R—some scholars pushed back. They saw the diagnosis as part of the historical oppression of women, done in the name of mental health. The controversy reared up again as PMDD remained in the 1994 DSM-IV, where it was also listed under “Depressive Disorder Not Otherwise Specified.” Many people who menstruate experience emotional changes during their cycles, so defining it as a mental illness could have serious personal and societal consequences, critics argued. A 2002 Monitor on Psychology article, “Is PMDD real?,” quoted the late psychologist and author Paula Caplan: “Women are supposed to be cheerleaders,” she said. “When a woman is anything but that, she and her family are quick to think something is wrong.”

    In the end, the APA weighed these concerns and pushed ahead, adding PMDD to the DSM-5 as an official diagnosis in 2013. But I found the criticism disquieting. Had I embraced a modern hysteria diagnosis? Were the symptoms I experienced even real?

    Researchers have looked for hormonal differences between people who experience severe premenstrual distress and people who don’t. In some cases, they’ve found them: A 2021 meta-analysis found that people with PMDD tend to have lower levels of estradiol, a form of estrogen, between ovulation and menstruation. But other studies have shown little to no difference in hormone levels. “There are no biomarkers. There’s no test that can be done which helps identify someone with PMDD,” says Lynsay Matthews, who researches PMDD at University of the West of Scotland.

    Instead, to receive treatment, people experiencing premenstrual distress have to monitor their own mind and body. PMDD diagnosis is based on a symptom diary kept over the course of multiple menstrual cycles.

    The symptoms recorded in those diaries can be severe. In a 2022 survey, 34 percent of people with PMDD reported a past suicide attempt. More than half reported self-harm. “If someone has suicidal ideation or self-harm, or suicide attempts every month for 30 years, that wouldn’t be described as a normal female response to the menstrual cycle,” Matthews says.

    There is evidence that SSRIs work for people with PMDD, in ways researchers don’t fully understand. “In some cases, hours after taking an effective SSRI, people can feel a lot better,” Matthews says, referring to PMDD patients. In contrast, people with depression usually need to take SSRIs for weeks before feeling the effects. Researchers know the drugs’ mechanism of action is different for PMDD—they just don’t know why. “When people find that out, they find it quite validating that it is a medical condition,” Matthews says.

    Tamara Kayali Browne, a bioethicist at Deakin University, in Australia, agrees that some people experience serious distress in the week before their period—but disagrees with calling it a mental illness.

    “The crux of the problem seems to be that we are in a patriarchal society that treats women very differently and puts a lot of women under a lot of significant, disproportionate stress,” Browne says. That disproportionate stress begins early. Eighty-three percent of a sample of Australian PMDD patients reported trauma in early life. It continues in adulthood. A Swedish survey of 1,239 people with PMDD found that raising children was associated with higher rates of premenstrual distress.

    Between ovulation and menstruation, many people experience higher physical and emotional sensitivity. They may feel unwilling or unable to deal with the stressors they tolerate the rest of the month: the screaming baby, the messy partner. “Is it the time of the month where the truth comes out?” Browne suggests. Seen in this light, irritability, anxiety, and low mood are understandable reactions to life stressors, not symptoms of mental illness.

    There is a long history of doctors labeling women crazy. There is also a long history of doctors dismissing women’s pain. Debates about premenstrual distress are caught in the middle.

    When critics question PMDD and the less severe premenstrual syndrome, it can feel invalidating. “It’s time to stop questioning whether women’s experiences are real and instead start making them real priorities,” the journalists Emily Crockett and Julia Belluz wrote in response to an article that suggested PMS is culturally constructed.

    At the same time, when left unchecked, casual sexism can seep into the medical discourse around PMDD. Early pharmaceutical advertisements marketing SSRIs for PMDD show how this works in practice. In 2000, Eli Lilly packaged fluoxetine hydrochloride in a pink-and-purple capsule and branded it Sarafem. Advertisements for the drug featured incapable, unreasonable women; one fights a shopping cart, another bickers with her (male) partner. “Think it’s PMS? Think again. It could be PMDD.” (The Sarafem brand has since been discontinued.)

    What if we can question the structural factors that make life harder for women while providing medical support for people who are suffering? Could the critiques lead us to more, not fewer, options for people with PMDD?

    Medical interventions can be lifesaving for people with PMDD. But they don’t address a society that places a heavy burden on the shoulders of people assigned female at birth.

    Browne compares severe premenstrual distress to a broken leg. “If you have a broken leg, you really do need painkillers, because you’re experiencing pain,” she says. “But it’s not going to be helpful in the long term if you don’t deal with whatever the underlying cause is.” In the week before menstruation, the life stressors a person with PMDD deals with the rest of the month can feel unbearable. Those life stressors can and should be addressed alongside conventional medical treatment.

    One common stressor is the caregiving load. “Parenting is not only a massive trigger, but it’s also the biggest burden or the biggest guilt that comes with having PMDD,” Matthews says. “Not only are you struggling yourself every month, but you also feel as though you’re failing your children every month.” The co-parent can help alleviate this burden. When fathers spend more time with their kids—and doing child-related chores—mothers tend to be less stressed about parenting.

    Another stressor is relationship difficulties. The emotional changes that come with the premenstrual phase can make conflict with a partner more likely. They can also prompt the PMDD sufferer’s partner to dismiss those feelings. “Nowadays, a partner might still be inclined to say, ‘Wait a minute, I know it’s that time of your month again. You’re just being oversensitive,’” Browne points out. Women in relationships with women, who tend to be more understanding of premenstrual change than men, report a more positive experience of the week before their period.

    Researchers have done great, necessary work to understand PMDD, work that should continue. How are people who experience premenstrual distress biologically different from people who don’t? Can we find new, more effective drugs to treat that distress?

    In the meantime, we need to build a better world for people who experience premenstrual distress. Doctors can prescribe medicine, but managers can make accommodations in the workplace. Co-parents can take on more caregiving responsibility. And partners can provide love and support.

    Ciara McLaren

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  • Jack Hanna’s family opens up about his Alzheimer’s diagnosis, saying he doesn’t know most of his family

    Jack Hanna’s family opens up about his Alzheimer’s diagnosis, saying he doesn’t know most of his family

    Jack Hanna’s family recently spoke about his Alzheimer’s diagnosis for the first time publicly. The zookeeper and media personality’s family spoke to The Columbus Dispatch about the disease, which affects cognitive function and memory, saying it has progressed to the point where Hanna doesn’t know most of his family.

    Hanna, who served as director of the Columbus Zoo from 1978 to 1992, first had symptoms of the disease in 2017. The 76-year-old had a long career as media personality, appearing as an animal expert on talk shows and hosting his own syndicated shows like “Jack Hanna’s Animal Adventures.”

    Alzheimer’s is the most common form of dementia, a term that describes a group of symptoms including memory loss and loss of other cognitive abilities, according to the Alzheimer’s Association. While it mainly affects adults 65 and older, it is not a normal part of aging. The disease usually progresses, with late-stage Alzheimer’s patients sometimes unable to carry on a conversation. 

    About 55 million people in the world have Alzheimer’s, and there is no direct cause but genetics may be a factor, according to the association. There is no cure for the disease, but there are treatments such as medication, which Hanna’s family says he takes to help combat symptoms. 

    This year, an experimental Alzheimer’s drug by Eli Lilly, donanemab, showed 35% less decline in thinking skills in patients receiving the infusions. 

    The Hanna family said in tweets they welcomed the Dispatch into their Montana home “for a real-world look into living with Alzheimer’s disease.”

    “While Dad/Jack is still mobile, his mind fails him, the light in his eyes has dimmed, and we miss who he was each & every moment of the day,” they wrote. 

    Hanna was officially diagnosed with Alzheimer’s in 2019, and retired from the zoo in 2020, shortly after his final stage performance with animals. 

    “He would have worked until the day he died. He only retired due to the Alzheimer’s,” his daughter, Kathaleen, told the Dispatch. “He was embarrassed by it. He lived in fear the public would find out.”

    Hanna’s wife, Suzi, said he didn’t want the public finding out about his diagnosis. But in 2021 — after the Columbus Zoo, which he was no longer directing, faced problems that included losing its main accreditation — some sought a response from Hanna. So, the family decided to reveal his diagnosis to the public. 

    Suzi said it “killed her” to break her promise and go public about his diagnosis. But still, Hanna doesn’t know his family told the public, they said. 

    Before his diagnosis, Hanna showed signs of memory loss – sometimes forgetting what city he was in or the names of animals he had with him during stage performances.

    Since then, his Alzheimer’s has advanced, his family said. “He just stopped remembering who I was in all ways,” his daughter, Suzanne, said on the phone during the Dispatch interview. “Whether it was in person or by phone, he had no idea I was his daughter.”

    When his other daughter, Julie, was diagnosed with a tumor, Hanna didn’t fully understand what was happening to her.

    Kathaleen explained why the family is now sharing his story. 

    “If this helps even one other family, it’s more than worth sharing dad’s story,” she said. “He spent a lifetime helping everyone he could. He will never know it or understand it, but he is still doing it now.”

    The family said on Twitter they have no plans for additional interviews. 

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  • Alibaba, Dice, Arcellx, Avis, PayPal, and More Stock Market Movers

    Alibaba, Dice, Arcellx, Avis, PayPal, and More Stock Market Movers


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  • A new experimental drug shows promise in fight against Alzheimer’s

    A new experimental drug shows promise in fight against Alzheimer’s

    A new experimental drug shows promise in fight against Alzheimer’s – CBS News


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    Drugmaker Eli Lilly says its new antibody infusion could slow cognitive decline in Alzheimer’s patients.

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  • Eli Lilly says its experimental Alzheimer’s drug appears to slow symptoms

    Eli Lilly says its experimental Alzheimer’s drug appears to slow symptoms

    Eli Lilly said Wednesday its experimental Alzheimer’s drug appeared to slow worsening of the mind-robbing disease in a large study, sending its stock up by 5% on investor optimism about the results.

    In the 18-month trial, people in the early stages of Alzheimer’s who received infusions of donanemab showed 35% less decline in thinking skills compared to those given a dummy drug, Lilly announced in a press release. About 6 million people in the U.S. have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and daily tasks.

    Shares of Lilly jumped nearly $19, or 4.7%, to $423 in morning trading.

    The Eli Lilly drug is designed to target and clear away a sticky protein called beta-amyloid that builds up into brain-clogging plaques that are one hallmark of Alzheimer’s.


    Wife who lost husband to Alzheimer’s wants to inspire other caregivers

    02:39

    A similar amyloid-targeting drug, Eisai and Biogen’s Leqembi, recently hit the market with similar evidence that it could modestly slow Alzheimer’s — and also some safety concerns, brain swelling or small brain bleeds.

    Donanemab also comes with that risk. Lilly said in its study, the brain side effects caused the deaths of two participants and a third also died after a serious case.

    The preliminary study results haven’t been vetted by outside experts. Indianapolis-based Lilly plans to release more details at an international Alzheimer’s meeting this summer and is seeking Food and Drug Administration approval of the drug.


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  • Eli Lilly seeks FDA approval for weight loss drug tirzepatide

    Eli Lilly seeks FDA approval for weight loss drug tirzepatide

    Eli Lilly seeks FDA approval for weight loss drug tirzepatide – CBS News


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    Pharmaceutical giant Eli Lilly is requesting fast-track approval from the Food and Drug Administration for its Type 2 diabetes medication tirzepatide to be sold as a weight loss drug. The company said that new studies have shown promising results. Nikki Battiste has more.

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  • A New Weight-Loss Drug Could Be a Complete Game Changer | Entrepreneur

    A New Weight-Loss Drug Could Be a Complete Game Changer | Entrepreneur

    In recent months, there has been a swelling interest in using diabetes drugs to treat weight loss.

    Drugs with brand names such as Ozempic and Wegovy have become so popular with Hollywood celebrities and TikTokers; it’s led to a nationwide shortage for diabetics.

    But the anti-obesity drug craze is about to be rocked by another major development. The diabetes drug Mounjaro could be approved by the U.S. Food and Drug Administration (FDA) for weight loss later this year, according to manufacturer Eli Lilly. The company just completed a late-stage study of the drug for weight loss and found the participants lost more than 50 pounds in nearly 17 months.

    “We have not seen this degree of weight reduction,” Dr. Nadia Ahmad, Lilly’s medical director of obesity clinical development, told CBS News.

    Analysts predict that Mounjaro, tirzepatide generically, could become one of the biggest-selling drugs ever. Evaluate Pharma estimates as much as $50 billion in sales by 2028. To put this in perspective, Novo Nordisk, which makes Ozempic and Wegovy, reported combined sales of about $2.4 billion in 2022.

    How does Mounjaro work?

    Mounjaro was approved by the FDA last year to treat Type 2 diabetes. Patients take it via injection once per week. The drug works by activating two hormones naturally produced in the body that help to reduce appetite and increase feelings of fullness. It also curbs craving signals chemically sent from the gut to the brain.

    “Psychologically, you don’t want to eat,” said Matthew Barlow, a health technology executive, told CBS News. “Now I can eat two bites of a dessert and be satisfied.”

    Though trials have shown the drugs to be safe, side effects include nausea and constipation.

    Mounjaro isn’t cheap. A monthly dose can run as much as $1,400. But if the FDA approves it for weight loss, people prescribed the medication for obesity could more easily be covered by insurance.

    Jonathan Small

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  • Ozempic Is About to Be Old News

    Ozempic Is About to Be Old News

    All of a sudden, Ozempic is everywhere. The weight-loss drug that it contains, semaglutide, is a potent treatment for obesity, and Hollywood and TikTok celebrities have turned it into a sensation. In just a few months, the medication has been branded as “revolutionary” and “game-changing,” with the power to permanently alter society’s conceptions of fatness and thinness. Certainly, a drug like semaglutide could be all of those things: Never in the history of medicine has one so safely led to such dramatic weight loss in so many people.

    But let’s not get ahead of ourselves. As weight-loss medications go, Ozempic is far from perfect. Though the drug has profound impacts, it requires weekly injections, a tolerance for uncomfortable side effects, and the stamina—not to mention the budget—for long-term treatment. (Ozempic has somehow become a catchall term for semaglutide but technically that product has gotten FDA sign-off only as a diabetes medication. A larger dose of semaglutide, marketed as Wegovy, has been approved for weight loss.)

    Made by the Danish drugmaker Novo Nordisk, semaglutide dominates the U.S. weight-loss market right now, but its reign might be short-lived. The colossal demand for these drugs has spurred a competition in the pharmaceutical industry to develop even more potent and powerful medications. The first of them could become available as soon as this summer. For all its hype, semaglutide is the stepping stone and not the final destination of a new class of obesity drugs. Just how good they get, and how quickly, will go a long way in determining whether this pharmaceutical revolution actually meets its full promise.

    In a sense, semaglutide hardly represents a major step forward in science. Diet drugs are nothing new, and even the category of pharmaceuticals that these new products belong to, called “GLP-1 agonists,” has been around for several years. These drugs mimic the hormone GLP-1 (glucagon-like peptide one) and bind to its receptor in the body. This triggers a sense of fullness associated with having just eaten, and also slows the release of food from the stomach. (It also increases insulin secretion, keeping blood sugar in check, which is why Ozempic is still intended as a diabetes drug.) Already, these pharmaceuticals have gotten better over time: A daily injection called liraglutide and sold as Saxenda, which was approved by the FDA in 2014 for obesity, leads to the loss of 5 to 10 percent of a person’s body weight in most cases. But one reason semaglutide took off in a way that liraglutide didn’t is that it can lead to weight loss of up to 20 percent. “Now you have a shot that’s once a week instead of every day, you’re making dramatic improvements, and people notice more,” Angela Fitch, the president of the Obesity Medicine Association and the chief medical officer of the obesity-care start-up Knownwell, told me.

    But not everyone who takes these drugs can achieve that level of weight loss. More than 60 percent of those on Wegovy experience smaller changes, in part because the drug can’t account for the complex drivers of obesity that aren’t related to food. The next generation of drugs is reaching for more. The first leap forward is Mounjaro, known generically as tirzepatide, a diabetes drug from Eli Lilly that the FDA is expected to approve for weight loss this year. In one study, it led to 20 percent or more weight loss in up to 57 percent of people who took the highest dose; The Wall Street Journal recently called it the “King Kong” of weight-loss drugs. People on Mounjaro tend to lose more weight more quickly and generally have a “better experience” than those on Wegovy, Keith Tapper, a biotech analyst at BMO Capital Markets, told me. It’s also cheaper, though by no means cheap, at roughly $980 for the highest-dose option, he said; a dose of Wegovy costs about $1,350.

    These leaps in potency are happening on the molecular level. Like semaglutide, Mounjaro mimics the effects of GLP-1, but it also hits receptors for another hormone—GIP. That leads to even more weight loss by further attenuating focus on food and potentially also increasing the activity of a fat-burning enzyme, said Tapper. So-called dual-agonist drugs “offer a step change” in both weight loss and blood-sugar control, he added.

    And why stop at two receptors when so many others are involved in regulating hunger? “This area is exploding in terms of research and testing different combinations of hormones,” which are still poorly understood, Shauna Levy, a professor specializing in bariatric surgery at Tulane University School of Medicine, told me. Eli Lilly has another drug in the works that targets three receptors; one from the drugmaker Amgen works by “putting the brakes” on the GIP receptor and “putting the gas” on GLP-1’s, a company spokesperson told me. Several other companies have already joined what some have dubbed a “race” to develop the next great obesity drug, in which Lilly, Pfizer, Amgen, Structure Therapeutics, and Viking Therapeutics are expected to be the front-runners, said Tapper.

    The potency of weight-less drugs is not the only factor that will determine the shape of their future trajectory. Wegovy and Mounjaro injections are tolerable for most people, but they are less convenient than a pill. Making oral versions of these drugs isn’t as easy as packing everything into a capsule, though. Semaglutide is a molecule that gets chewed up in the stomach. For this reason, the semaglutide pill Rybelsus, which is already approved for diabetes, leads to far less dramatic weight loss than its injectable kin. But drugmakers are undeterred by this complication, because a pill even more powerful than semaglutide would no doubt have many customers. In January, Pfizer’s CEO Albert Bourla said that an oral weight-loss drug “unlocks the market,” which he estimated could eventually be worth $90 billion. Pfizer doesn’t have any weight-loss drugs yet but is developing a twice-daily GLP-1 agonist pill; Eli Lilly also has an oral version in the works. Tapper expects those drugs to become available in 2026, and a similar offering from Structure Therapeutics is likely to follow the next year.

    Drugmakers will also likely vie to create drugs with fewer side effects. Novo Nordisk notes that gastrointestinal issues are common with semaglutide; accounts of horrible nausea, constipation, and vomiting have proliferated online. As one actor put it to New York Magazine, people on Ozempic are “shitting their brains out.” With Wegovy, more serious issues, such as pancreatitis, thyroid cancer, and kidney failure, are also possible but are considered rare. Although nothing to scoff at, side effects tend to subside with prolonged treatment and can usually be managed with help from a doctor, said both Fitch and Levy, who regularly prescribe semaglutide to patients with obesity. It’s possible, Levy added, that people experiencing really terrible effects may be getting their drugs from shady compounding pharmacies or even from other countries.

    The fact that people are turning to sketchy outlets to get weight-loss drugs underscores the biggest issue with them: access. Medicare and most private insurance companies don’t cover anti-obesity drugs. (Such drugs are classified as “cosmetic” by the Centers for Medicare and Medicaid Services, and thus don’t qualify for coverage.) “I am hopeful that the price will come down with more competition,” Fitch told me. But there’s no guarantee that will happen: Competition typically makes a product cheaper over time, but research suggests that isn’t always the case in pharmaceuticals. Even if the drugs do become cheaper, they may not become cheap enough. The oral forms of these drugs, some of which could be available by 2026, are expected to cost about $500 a month, Tapper said. By 2030, the cost of obesity drugs could come down to about $350 a month, according to a recent Morgan Stanley analysis, which would still be out of reach for many Americans.

    Levy estimates that the next five years will bring about a “huge explosion” of next-gen obesity drugs. In that case, the market will likely expand to accommodate a variety of drugs with different price points and efficacies. Some people may aim to lose 20 or more percent of their body weight; some may be content with less. The market is so diverse that it will likely “support a broad range of options,” said Tapper, such as cheaper, lower-dose oral drugs for people who have milder medical issues, and more expensive injectables for those with more severe medical concerns. That opens up the possibility that medically mediated weight loss could soon be an option for a far greater proportion of people.

    Regardless of how much these drugs’ costs may decrease, they will always add up if people are paying out of pocket for them. They are meant to be taken long term: Once a person stops taking Wegovy, the weight tends to come right back. The current crop of weight-loss medications are essentially maintenance drugs, much like the cholesterol-busting drug Lipitor, which is taken daily to treat long-term disease. But Lipitor, unlike obesity drugs, is generally covered by insurance. Unless obesity drugs receive the same kind of coverage, no level of improvement will lead them to deliver on what Ozempic is promising us now.

    Yasmin Tayag

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  • Eli Lilly Slashed Insulin Prices. This Starts a Race to the Bottom.

    Eli Lilly Slashed Insulin Prices. This Starts a Race to the Bottom.

    When drugmaker Eli Lilly announced Wednesday it will slash the list price for some of its insulin products following years of criticism from lawmakers and activists that the price of the lifesaving hormone had become unaffordable, the news raised questions about what will happen to other efforts to provide low-cost insulin.

    Civica, a nonprofit drugmaker based in Utah, for example, has said it plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Eli Lilly’s generic insulin.

    In December, billionaire entrepreneur Mark Cuban said his new company, the Mark Cuban Cost Plus Drug Co., planned to sell low-cost insulin. And California is poised to launch an ambitious program to manufacture its own brand of the hormone, as well as generics of other high-priced prescription drugs.

    Drug pricing experts welcomed the Eli Lilly news, predicting the move won’t undercut those efforts. And these other initiatives to bring lower-cost insulin to market, in turn, would put pressure on Eli Lilly to keep its prices down. Together these will help, not hamper, what could become a race to the bottom on insulin prices.

    “The more competition, the more stable this solution will be so that five to 10 years from now the prices won’t go up again,” said Dr. Vincent Rajkumar, a Mayo Clinic oncologist who has been a critic of high drug costs.

    The pressure could cause further ripples. Following Eli Lilly’s news, Sen. Bernie Sanders (I-Vt.) sent letters to the two other major insulin makers, Sanofi and Novo Nordisk, calling on them to follow suit.

    People with diabetes, especially those with Type 1 who need the drug to survive, will benefit. Yet even while some of Eli Lilly’s persistent critics praised the move, they noted work remains to make insulin widely affordable.

    “Additional competition and other accountability moves are still incredibly necessary because the companies can raise their list price again at any time,” said Elizabeth Pfiester, founder of T1International, a nonprofit that advocates for people with diabetes. “That’s why the government also needs to regulate insulin manufacturers to hold them accountable.”

    Cuban’s company did not respond to requests for comment on how the Eli Lilly cuts might affect its efforts. But Civica’s plan remains unchanged following the news, said spokesperson Debbi Ford.

    “From the beginning, we have said we are not entering medicine markets for market share,” Ford said. “We are participating for market impact.”

    Democratic California Gov. Gavin Newsom tweeted Wednesday that “sky high prices for insulin have put it out of reach for too many” and his state will manufacture its “OWN insulin and ensure all who need access to this medicine” can afford it.

    “Now, Eli Lilly is lowering their cost,” Newsom wrote. “Let’s keep it up.”

    Last year, California lawmakers approved $100 million for the state to contract for cheaper insulin and make the lifesaving drug, cutting out drugmakers and go-between companies that add to the price consumers pay. Newsom has said that California’s insulin would be available “at a cheaper price, close to at cost.” Officials haven’t said when the state’s insulin will be available, though, or exactly how much it will cost.

    “California’s goal was to get competition into the market however they can manage it,” said Robin Feldman, a professor at the University of California College of the Law-San Francisco who studies the insulin market. “If California’s entry results in bringing prices down from other manufacturers, that will be a good thing.”

    Eli Lilly’s price cuts apply to what it described as its “most commonly prescribed” insulins, but Feldman noted those are older insulin products. Although California officials haven’t released details about which insulin products would be included in its program, Feldman said she expects the state will offer a variety to cover the market.

    “It’s not aimed at any one company or any one drug,” she said. “It’s aimed at making affordable insulin available to market and putting pressure on other companies.”

    Washington and Maine are also exploring ways to bring cheap insulin to consumers, and large insurance companies pledged millions in an agreement with Civica to manufacture cheaper insulin.

    The cadre of newcomers aim to break open the insulin market because three pharmaceutical companies — Eli Lilly and Co., Sanofi, and Novo Nordisk — have long dominated the U.S. insulin supply and allowed their prices to escalate. The price of one of Eli Lilly’s products, for example, rose from $21 to $255 per vial between 1996 and 2016.

    St. Louis University law professor Dr. Michael Sinha said Eli Lilly may have seen a threat from the discount insulin initiatives.

    “This might be a response to some of those initiatives and the looming threat of really steep losses in terms of market share,” Sinha said.

    University of California-San Diego pharmaceutical professor Inmaculada Hernández offered another possible reason for the price cut: changes to how drugs are paid for by Medicaid.

    Beginning in 2024, Hernández said, drugmakers could be on the hook to pay fees, known as rebates, to Medicaid for drugs like insulin that have had steep price hikes. By lowering the list price of insulin, Eli Lilly could avoid those costs, Hernández said.

    Hernández said that understanding the incentives behind Eli Lilly’s decision to cut list prices could help lower the price of other drugs that patients have trouble affording. If the makers of those other drugs also slash their list prices ahead of 2024, it could show the effectiveness of the new federal policy. If they don’t, it might underscore the importance of factors unique to insulin like public pressure by politicians and activists or market competition from initiatives like California’s.

    This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

    KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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    Bram Sable-Smith and Samantha Young

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  • Tanking Biotech Stocks Will Mean a Big Year for Deals. Who Could Benefit.

    Tanking Biotech Stocks Will Mean a Big Year for Deals. Who Could Benefit.

    Nearly two years after biotechnology stocks began to tumble, executives at small and midsize companies in the space are finally accepting that share prices aren’t bouncing back anytime soon.

    With reality setting in, it’s a buyer’s market for companies looking for acquisitions and partnerships, according to many of the pharmaceutical and medical technology executives who gathered at this year’s


    J.P. Morgan


    healthcare investor conference, which wrapped up in San Francisco on Thursday.

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