CVS Health is launching a new subsidiary unit, Cordavis, that will collaborate with drug manufacturers to produce biosimilar products, or medications that are near identical to an already approved and existing drug. This unit will commercialize and co-produce FDA-approved biosimilar products to U.S. markets, which will likely have a trickle-down effect on the way consumers buy drugs by increasing competition and driving down prices.

This subsidiary will not reinvent the wheel with new drugs. All the biosimilar products produced will be highly similar to an already approved biologic medicine but will still undergo testing and approvals to ensure they are highly comparable in terms of safety, efficacy and quality. If generic drugs are the Kirkland brand of medication — an identical product made cheaper through the expiration of a patent — biosimilars are more like Amazon Basics: less expensive, legally distinct but functionally the same as what they imitate. CVS claims that Cordavis will "help ensure consistent long-term supply of affordable biosimilars" when it officially debuts at the beginning of 2024.

The first confirmed offering from Cordavis in the near future is Hyrimo, a biosimilar of the drug Humira. Humira is an injectable drug that is used to treat a range of diseases, including Crohn's and rheumatoid arthritis in adults. The drug is a popular prescription that generated its maker AbbVie net revenues of $3.5 billion in global sales in the second quarter of 2023. It has a list price of nearly $7,000 a month, making it a prime drug worth diluting in the competitive pharmaceutical landscape. Cordavis says its biosimilar for Humira will list under a new private label and will be 80 percent cheaper than the current list price of the drug. This early offering gives just a snapshot of the kind of influence Cordavis can have on disruption in the drug manufacturing space.

Biogen and Sage Therapeutics' collaboration to develop Zurzuvae has proved fruitful. The FDA approved the oral pill specifically for the treatment of postpartum depression (PPD), making it the first of its kind in a class of antidepressants intended specifically for new mothers. According to research by the CDC, one in eight women will experience symptoms of postpartum depression. Symptoms of PPD can occur quite intensely after birth and can be dangerous because it can interfere with a new mother’s ability to function. The long-awaited approval comes thanks to two randomized, double-blind studies that proved the efficacy of the drug.

A key hallmark of Zurzuvae is that the medication is expected to work within just a few days and is meant to be taken for up to two weeks. Before this once-daily oral pilll, the most common treatment plan for PPD required an IV injection. That meant administration by a healthcare provider in a hospital or healthcare facility was necessary. With this approval, Zurzuvae will be able to expand access and reach to more women on their way out of hospitals.

The catch is the drug can impact a patient's ability to drive and cause extreme drowsiness. Additionally, the warning label for the drug highlights that, like most antidepressants, the drug can cause an increased risk for suicidal ideation. To top it off, Zurzuvae may also cause fetal harm. Patients on the drug should use contraception while taking the pill and for one week after taking Zurzuvae.

Johnson & Johnson's Medical technology arm received FDA approval for a new workflow that will make it safer for medical professionals to treat atrial fibrillation, a condition that makes your heartbeat irregular and can cause stroke or heart failure. Several products developed by Biosense Webster, which is part of J&J MedTech, got the OK for a "zero fluoroscopy workflow" from the FDA, meaning live X-ray imaging will no longer be needed during catheter insertion procedures. Instead of using X-rays to insert Biosense catheters, medical professionals can now use ultrasound to guide treatments.

Using fewer X-rays, or fluoroscopy, lowers radiation exposure for both patients and medical professionals. Currently, doctors and medical staff who work in treatment rooms that specialize in treating relevant heart procedures often get too much exposure to radiation over time, which can lead to problems like eye issues, cancer, and bone injuries. This FDA approval helps address the recurring occupational hazard. Providers working in cath labs also won't have to wear heavy protective gear like lead aprons anymore when applying the newly approved workflow, reducing the risk of long-term muscle and bone pain.

This move by the FDA marks the first and only approval of its kind. The thumbs up was based on data from clinical trials and research from the REAL AF Registry, or the real-world evidence registry in the electrophysiology field. The data backed how well the treatment works in real-life situations. The new method will only apply for Biosense products like the THERMOCOOL SMARTTOUCH SF catheter, the most commonly used ablation catheter, among others.

When Major League Soccer (MLS) announced plans to deploy AI-powered tools in its recruiting program starting at the tail end of this year, the eyebrows of skeptics were raised. The MLS will be working with London-based startup ai.io, and its ‘aiScout’ app to help the league discover amateur players around the world. This unprecedented collaboration is the first time the MLS will use artificial intelligence in its previously gatekept recruiting program, forcing many soccer enthusiasts and AI fans to reckon with the question: has artificial intelligence finally entered the mainstream in the professional soccer industry?

There is no doubt that professional sports have been primed for the potential impact of artificial intelligence. Innovations have the potential to transform the way we consume and analyze games from both an administrative and fan standpoint. For soccer specifically, there are opportunities for live game analytics, match outcome modeling, ball tracking, player recruitment, and even injury predicting — the opportunities are seemingly endless.

"I think that we're at the beginning of a tremendously sophisticated use of AI and advanced analytics to understand and predict human behaviors," Joel Shapiro, Northwestern University professor at the Kellogg School of Management said. Amid the wave, some experts believe the disruption of the professional soccer industry by AI is timely. It’s no secret that soccer is the most commonly played sport in the world. With 240 million registered players globally and billions of fans, FIFA is currently made up of 205 member associations with over 300,000 clubs, according to the Library of Congress. Just days into the 64-game tournament, FIFA officials said that the Women’s World Cup in Australia and New Zealand had already broken attendance records.

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The need for more players and more talent taking on the big stage has kept college recruiting organizations like Sports Recruiting USA (SRUSA) busy. "We've got staff all over the world, predominantly in the US …everyone is always looking for players," Chris Cousins, the founder and head of operations at SRUSA said. Cousins said he is personally excited about the potential impact of artificial intelligence on his company and, in fact, he is not threatened by the implementation of predictive analysis impacting SRUSA's bottom line. "It probably will replace scouts," Cousins said, but at the same time, he said he believes the deployment of AI will make things more efficient. "It will basically streamline resources … which will save organizations money." Cousins shared that SRUSA has already started dabbling with AI, even if only in a modest way. It collaborated with a company called Veo that deploys drones that follow players and collect video for scouts to analyze later. 

Luis Cortell, senior recruiting coach for men’s soccer for NCSA College Recruiting, is a little less bullish, but still believes AI can be an asset. “Right now, soccer involves more of a feel for the player, and an understanding of the game, and there aren't any success metrics for college performance. While AI won’t fully fill that gap, there is an opportunity to help provide additional context.”

At the same time, people in the industry should be wary of idealizing AI as a godsend. "People expect AI to be amazing, to not make errors or if it makes errors, it makes errors rarely," Shapiro said. The fact is, predictive models will always make mistakes but both researchers and investors alike want to make sure that AI innovations in the space can make "fewer errors and less expensive errors" than the ones made by human beings.

But ultimately, Shapiro agrees with Cousins. He believes artificial intelligence will replace some payrolls for sure. "Might it replace talent scouts? Absolutely," he said. However, the ultimate decision-makers of how resources are being used will probably not be replaced by AI for some time. Contrary to both perspectives, Richard Felton-Thomas, director of sports sciences and chief operating officer at ai.io, said the technology being developed and used by the MLS will not replace scouts: “Scouts are super important to the mentality side, the personality side, you've still got to watch humans behave in their sporting arena to really talent ID them.”

Photo by Rob Hart

When the aiScout app launches in the coming weeks and is used by the MLS later this year, players will be able to take videos of themselves performing specific drills. Those will then be uploaded and linked to the scout version of the app, where talent recruiters working for specific teams can discover players based on whatever criteria they choose. For example, a scout could look for a goalie with a specific height and kick score. Think of it as a cross between a social media website and a search engine. Once a selection is made, a scout would determine whether or not they should go watch a player in person before making any final recruitment decisions, Felton-Thomas explained.

“The main AI actually happens less around the scoring and more around the video processing and the video tracking,” Felton-Thomas said. “Sport happens at 200 frames per second type speeds, right? So you can’t just have any old tracking model. It will not track the human fast enough.” The AI algorithms that have been developed to analyze video content can translate human movements into what makes up a player’s overall performance metrics and capabilities. 

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These ‘performance metrics’ can include biographical data, video highlights and club-specific benchmarks that can be made by recruiters. The company said in a statement that the platform’s AI technology is also able to score and compare the individual players’ “technical, athletic, cognitive and psychometric ability.” Additionally, the AI can generate feedback based on benchmarked ratings from the range of the club trials available. The FIFA Innovation Programme, the experimental arm of the association that tests and engages with new products that want to enter the professional soccer market, reported that ai.io’s AI-powered tools demonstrate a 97 percent accuracy level when compared to current gold standards.

Beyond the practical applications of AI-powered tools to streamline some processes at SRUSA, Cousins said that he recognizes a lot of the talent recruitment process is “very opinion based" and informed by potential bias. ai.io's talent recruitment app, because it is accessible to any player with a smartphone, broadens the MLS’ reach to disadvantaged populations. The larger goal is that aiScout will potentially disrupt bias from continuing to play a huge role in who gets what opportunity, or at least in the pre-screening process. Now, a scout can make the call to see a player in real life based on objective data related to how a player can perform physically. “The clubs are starting to realize we can't just rely on someone's opinion,” Felton-Thomas said. Of course, it's not an end-all-be-all for bias, considering preferential humans are the ones coding the AI. There is no complete expunging of favoritism from the equation, but it is one step in the right direction.

aiScout could open doors for players from remote or disadvantaged communities that don't necessarily have the means or opportunity to be seen by scouts in cups and tournaments. "Somebody super far in Alaska or Texas or whatever, who can't afford to play for a big club may never get seen by the right people but with this platform there, boom. They're going straight to the eyes of the right people," Cousins said about ai.io’s app.

The MLS wrote in a statement that ai.io's technology "eliminates barriers like cost, geography and time commitment that traditionally limit the accessibility of talent discovery programs." Felton-Thomas said it is more important to understand that ai.io will “democratize” the recruiting process for the MLS, ensuring physical skills are the most important metric when leagues and clubs are deciding where to invest their money. “What we're looking to do is give the clubs a higher confidence level when they're making these decisions on who to sign and who to watch.” By implementing the AI-powered app, recruitment timelines are also expected to be cut.

Silvia Ferrari, professor of mechanical and aerospace engineering at Cornell and ​​Associate Dean for cross-campus engineering research, who runs the university's 'Laboratory for Intelligent Systems and Controls' said she couldn't agree more. AI has the potential to complement the expertise of recruiters while also helping, "eliminate the bias that sometimes coaches might have for a particular player or a particular team,” Ferrari said. Adjacent to this subject, algorithms developed in Ferrari's lab can accurately predict the in-game actions of volleyball players with more than 80% accuracy. Now the lab, which has been working on AI-powered predictive tools for the past three years, is collaborating with Cornell's Big Red men's ice hockey team to expand the project’s applications. Ferrari and her team have trained the algorithm to extract data from videos of games and then use that to make predictions about game stats and player performance when shown a new set of data.

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"I think what we're doing is, like, very easily applicable to soccer," Ferrari said. She said the only reason her lab is not focused on soccer is because the fields are so large that her team’s cameras could not always deliver easily analyzed recordings. There is also the struggle with predicting trajectory and tracking the players, she explained. However, she said in hockey, the challenges are similar enough, but because there are fewer players and the fields are smaller, so the variables are more manageable to tackle.

While the focus at Ferrari’s lab may not be soccer, she is convinced that research in the predictive AI space has made it “so much more promising to develop AI in sports and made the progress much faster." The algorithms developed by Ferrari's lab have been able to help teams analyze different strategies and therefore help coaches identify the strengths and weaknesses of particular players and opponents. “I think we're making very fast progress," Ferrari said.

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The next areas Ferrari plans to try to apply her lab’s research to include scuba diving and skydiving. However, Ferrari admits there are some technical barriers that need to be overcome by researchers. "The current challenge is real-time analytics," she said. A lot of that challenge is based on the fact that the technology is only capable of making predictions based on historical data. Meaning, if there is a shortage of historical data-there is a limit to what the tech can predict. Beyond technical limitations, Felton-Thomas said implementing AI in the real world is expensive and without the right partnerships, like the ones made with Intel and AWS, it would not have been possible fiscally.

Felton-Thomas said ai.io expects “tens of millions of users over the next couple of years.” And the company attributes that expected growth to partnerships with the right clubs, like Chelsea FC and Burnley FC in the UK, and the MLS in the United States. And while aiScout was initially designed for soccer, the company touts that its core functionalities can be adapted for use in other sports.

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But despite ai.io’s projections for growth and all the buzz around AI, the technology is still a long way from being fully trusted. From a technology standpoint, Ferrari said “there's still a lot of work to be done” and a lot of the need for improvement is not just based on problems with feeding algorithms historical data. Predictive models need to be smart enough to adapt to the ever-changing variables in the current. On top of that, public skepticism of artificial intelligence is still rampant in the mainstream, let alone in soccer.

“If the sport changes a little bit, if the way in which players are used changes a little bit, if treatment plans for mid-career athletes change, whatever it is, all of a sudden, our predictions are less likely to be good,” Shapiro said. But he’s confident that the current models will prove valuable and informative. At least for a little while.

GoodRx, best known for its prescription drug price comparison tool, has launched a new free offering called “Medicine Cabinet.” The tool will allow GoodRx app users to manage their prescription medications on a single platform. This comes on the heels of the news that the company is working with CVS Health to develop the Caremark Cost Saver, which could lower pharmacy out-of-pocket drug costs for shoppers.

Medicine Cabinet will automatically integrate within the GoodRx app and will feature tools like a “prescriptions dashboard” where a consumer can set up refill reminders and find the best pharmacies to pick up their medications at the lowest price. At the heart of the app are daily pill reminders that are customizable to any treatment plan that is uploaded into the app. GoodRx Chief Product Officer Mark Hull said the reminders feature is huge because 50 percent of the time, Americans are struggling to take their medications as prescribed for reasons as simple as forgetfulness or cost.

The Medicine Cabinet also includes a dashboard for GoodRx’s rewards program which offers users monetary perks like e-gift cards for staying on top of medication refills. “Nobody's integrating or rewarding people for having those healthy habits,” Hull said.

“What we've found is that the winning model for us is to marry the discounts, the value and the rewards, with the basic healthy habits and reminder stuff,” he added. GoodRx claims it can save consumers up to 80 percent off the price of prescription drugs by partnering with pharmacy benefits managers to negotiate deals on drugs. Normally, the average consumer wouldn’t otherwise have access to these discounts without middlemen like GoodRx.

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The Medicine Cabinet tool has only been in development for roughly six months and will be available on iOS, but not on Android just yet.

“GoodRx was able to develop Medicine Cabinet so quickly in part due to the data it has already amassed from users and providers over the last decade.” "If a startup were doing this, it would take a long time, they don't have the data, they don't have the relationships with retailers, they don't already have the customer base," Hull said. “We already have a half a billion prescriptions in federal records from the millions of people who have been using us for the last 12 plus years.”

Hull said he actually wishes Medicine Cabinet could have come sooner. He recalls when his stepfather had a heart attack a couple of years ago. "When he came home from the hospital, he had like a dozen medications he had to manage," Hull said, remembering it as a nerve wracking time for his family and specifically his mother. "For the average person who's managing a condition with multiple medications, it's a lot of work and so we're really trying to make it simple, clear and obvious what you need to do at any given point to help manage your condition."

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Down the line, Hull hopes Medicine Cabinet will be easier for older people to use, with the inclusion of features that will let a user take a photo of a medication instead of having to look it up in the database.

Still, GoodRx's history of being caught up in legal trouble related to data privacy issues is worth noting. Earlier this year, the Federal Trade Commission fined the company for the unauthorized disclosure of customers' identifiable health information with third parties, such as Facebook and Google. “Our privacy policy applies to Medicine Cabinet, which sits within the GoodRx app. We are very transparent about what information we collect and how we use it to personalize and customize our products for consumers. Additionally, the feature is only available for users who have registered for a GoodRx account,” a representative said. The company’s recent focus on transparency and adherence to privacy policies suggest it's taking the issue seriously, though as with any telehealth company, data privacy will always be a front and center concern.

“Let’s see what a Snickers bar does to my blood sugar,” Justin Richard, a 52-year-old Toronto-based TikToker says just before eating the candy bar on camera. After an edited time skip, Richard says, “It’s been several hours since I’ve had the chocolate bar, let’s have a look at the glucose monitor and see what actually happened.” He slightly lifts his arm flashing the device, an inconspicuous blue circular patch that almost looks like a Band-Aid. Above his head flashes a screenshot of his blood glucose reading, which appears to have spiked, dipped, and spiked again. “I had a spike in my blood sugar,” he says. “That's not a shock because this is loaded with sugar.” A red ‘X’ graphic appears over some b-roll of the Snickers bar. “I did this test because I’m trying to establish a benchmark.”

This is a typical 60-second TikTok from Richard, whose handle is @insulinresistant1 on the platform. In the following clip, Richard eats a cup of broccoli before eating another full Snickers bar, then goes on to share the results of his blood glucose levels from his personal continuous glucose monitor. He eats this oddball combination to show how variations in his food intake can impact or even prevent a blood glucose spike.

Continuous glucose monitors (or CGMs) have long been used as a tool to track blood sugar levels for people with Type 1 and Type 2 diabetes. Here’s the thing, though: Richard does not have diabetes.

While monitoring sugar intake is standard practice for people on tight blood sugar control treatment plans and those with persistently low blood glucose levels, modern CGM devices – non-invasive wearables that can attach to the back of an arm for weeks at a time – have become a popular wellness trend on social media. Users like Richard that have integrated a CGM into their daily life have stormed platforms like TikTok and Instagram. Some internet health coaches and dieticians have trumpeted their praise. On TikTok, the hashtags #insulinresistance has 1.2 billion views, while #continuousglucosemonitor has over 32.7 million views. Richard, who has over 800,000 TikTok followers, is just one influencer who helped fuel this trend. On his page, which he started during the pandemic, showcases him eating a wide range of foods and drinks, from sodas to chocolate bars, reacting to readings emitting from his Signos-sponsored CGM device.

Richard says he got into continuous glucose monitoring to “optimize his health” and prevent chronic illness, which was especially important to him considering his extensive family history of Type 2 diabetes. “It's like having a coach,” he said in an interview. “But the coach is telling you to do something.” That something was to make some pretty dramatic dietary changes. “'I'm not a healthcare professional and I don't pretend to be. All of my tests are about my blood sugar, and what I read online and how it affects me,” he said, adding that his disclaimer that “individual results will vary” is a key part of his messaging.

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Blood glucose monitoring devices are not new. In the late 1990s, medical companies like Medtronic, Dexcom and Abbott revolutionized the way diabetes could be managed. The importance of continuous glucose monitoring for patients is well established as a means of improving glycemic control, especially in the case of Type 1 diabetes.

CGMs are a vital tool for preventing diabetic ketoacidosis, a life-threatening complication seen in Type 1 diabetic patients. When sugar levels are too high and the body begins to break down fat as fuel, it can lead to a high amount of acid circulation in the bloodstream. For non-diabetics, however, complications stemming from extremely high or low blood sugar levels isn’t a concern. There is little to no research to back that monitoring blood glucose levels in generally healthy adults equates to an overall improvement in health. 

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Dr. Idz, another TikToker with over 1.7 million followers, calls the use of CGM devices for adults without any prescribed medical need a “feature of disordered eating.” Dr. Idz, short for Idrees Mughal, is a board-certified UK-trained medical doctor with expertise in nutritional research. He became a prominent figure when he started rebuking the “nonsense health information” circulating on TikTok that “prey[s] on people's vulnerabilities.” He says CGMs aren’t really intended for non-diabetics because “our body is designed to regulate the spike.” Dr. Idz says people need to understand that spiking blood glucose is not a problem. In fact, that is supposed to happen when you eat food. “Even protein can spike your blood glucose, and no one is really hyped about that, right?”

Although there may not be an inherent physical risk for people who wear a CGM device to monitor and track sugar levels, there is a real possibility that access to “too much data” can lead to information overload, false alarms, unnecessary anxiety, confusion or misinterpretation. Slight fluctuations in blood sugar levels are normal in people who don’t have diabetes. Dr. Robert Shmerling, a senior faculty editor for Harvard Health Publishing and author of “Is blood sugar monitoring without diabetes worthwhile?” writes that, “we're at the very beginning of the learning curve for home monitoring of blood sugar in people without diabetes. Before buying into what may be the next fad in health monitoring, I think we need to learn a lot more.”

Still, it’s no surprise that more people are interested in experimenting with CGM devices. Not only are TikTokers promoting blood glucose monitoring as an indicator of health and wellness, but ads for CGM devices from up-and-coming brands like Nutrisense, Veri and Signos have been flooding social media.

The companies use language designed to sell the average person on the importance of regularly tracking blood sugar levels as a way to lose weight or as a “metabolism hack.” The idea is that eating refined carbs and sugary foods can spike blood glucose levels and, over time, the cells that are supposed to take up insulin and regulate glucose production in the liver become resistant to the hormone due to habitual bad dieting. Heather Davis, a registered and licensed dietitian and nutritionist at Nutrisense denies that the company promises weight loss through glucose monitoring. “A CGM is not a weight loss device per se,” she said. “The CGM is simply one tool among many that may support insights into how different dietary and lifestyle approaches influence metabolic health, including weight factors.”

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Dr. Idz would disagree with Nutrisense on that. He argues that the vast majority of people won't even know how to interpret CGM results. “Even me as a medical doctor, I would probably need to look at some reference values for each individual, you know, perhaps have to do some calculations. And that's me who's actually a medical doctor. Imagine the average person who's just going, ‘oh, my gosh, I've had a spike. That must mean it's bad, right?’ You don't even know how to interpret it. So it's going to be completely useless.”

Nutrisense’s Davis concedes that there is limited research currently looking at CGM use in non-diabetic populations, but she argues that “once upon a time, there was also limited research looking at CGM use in diabetic populations” and that the “risks of wearing a CGM are extremely minimal for most people.” Still, the FDA has never recommended continuous glucose monitoring for healthy individuals. It has only even approved a handful of devices for people who do suffer from diabetes. Although it may be useful for predicting a risk for pre-diabetes and diabetes, there is a consensus that more scientific studies are needed to observe CGM use among healthy populations.

Companies marketing their wearables to healthy people are entering a crowded, but growing market that’s ripe for exploitation. There is arguably an enormous opportunity for companies advertising to healthy individuals to reap financial benefits from the latest health fad.

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TikToker Richard says he thinks continuous glucose monitoring is only going to grow from here. “I don't think this trend is going to end anytime soon,” he said. “Anybody and every country that's adopted this fast food, highly processed diet is having this same increase in Type 2 diabetes and you really can't ignore it. So I think this trend is gonna continue as long as this fast food is so prevalent.” Dr. Idz, on the other hand, would argue that if you want to prevent diabetes, “that's fine but you're not going to do it by wearing a CGM because you know, as long as you're not insulin resistant, you'll find that you don't need you don't need a CGM.”

To make matters worse, not only are CGMs questionably useful for healthy individuals, but they can be expensive, too. The devices must be replaced every seven to 14 days depending on the manufacturer. Nutrisense does not accept insurance coverage on the grounds it is a “wellness program,” with monthly subscriptions starting at $225 and no-commitment plans reaching $399 a month. Competitors like Signos, which accepts insurance with a diabetes diagnosis, offers a monthly plan for its wearable and monitoring app, and that costs upwards of $449 a month. Veri may accept insurance, depending on the provider. And even though it’s able to dramatically undercut its competitors, the monthly fee of between $40 to $109 is hardly cheap. Richard, who has historically paid out of pocket for his CGM devices, believes the high cost is going to “save him money in the long run.”

Unfortunately, these lofty prices don’t just affect health-conscious TikTokers. Access to CGM devices for diabetic populations can be spotty. Individuals covered by Medicaid are less likely to have one covered, especially people of color, according to the American Diabetes Association (ADA).

Aside from the technology’s often inaccessible price points, some experts argue that there simply isn't enough guidance from the scientific community on CGM applications for healthy individuals. The ADA does not recommend CGM device use by healthy people, only clearly stating that the technology should be considered “from the outset of the diagnosis of diabetes that requires insulin management.”

Dr. Idz takes this a step further, stating flatly that “there is no evidence whatsoever that blunting blood sugar spikes does anything for our health.” He backs up his argument with research from a retrospective and randomized trial that focused on the impact of blood glucose monitoring in diabetic and non-diabetic populations. Dr. Idz says, if anything, research suggests that a low average blood glucose level is bad for you and might increase mortality risk over time due to diminished consumption of healthy nutrients and decreased liver function.

Harvard’s Dr. Shmerling reports he could not find a published study suggesting that monitoring blood glucose levels directly translated into improved health. “Unfortunately, some makers of CGM systems aren't waiting for solid research results to market these devices to healthy people. So, consumers and marketing professionals — not researchers or doctors — may wind up driving demand for the product,” Dr. Shmerling writes. Despite the lacking body of evidence to support blood glucose monitoring among healthy populations, the inflated price points for direct to consumer products, and the technological handicaps still present in the burgeoning industry, the growing popularity of CGMs among health and fitness enthusiasts does not seem to be slowing down.

Japanese drugmaker Eisai and US-based Biogen have been working together on advancing research in the space of Alzheimer’s for nearly a decade. Finally, the FDA, granted the fruits of that labor, Leqembi, its blessing for intravenous use. This marks the first approved treatment that can slow the progression of Alzheimer’s.

Leqembi received a preliminary approval in January that allowed it to be used in a limited capacity. That approval was conditioned on the two drug makers conducting a confirmatory study to verify the drug's clinical benefit.

Though Leqembi slows Alzihmer’s progression, it is not a cure. Instead, it addresses the underlying biology that spurs Alzheimer's advancement. The drug works by reducing amyloid plaques, or "misfolded" proteins that form in the brain of a person with Alzheimer's.

Leqembi isn’t the only drug targeting beta-amyloid plaque buildup to treat Alzheimer's. Aduhelm received approval under the accelerated pathway in 2021, but it’s still not fully FDA-approved. But what sets Leqembi apart from its predecessor is that the drug demonstrated actual clinical benefit in addition to simply reducing the buildup of the AD-inducing proteins.

Besides needing a medical prescription, taking the drug will require professional administration in a hospital or infusion center every two weeks. The company, though it may not be its sole responsibility, recognizes its need to boost accessibility. In a public statement, Christopher Viehbacher, the CEO of Biogen, said the company’s main focus now is to work with Eisai to make Leqembi “accessible to eligible patients as soon as possible.”

The drug’s hefty price tag of $26,500 will unfortunately make it inaccessible to most. Current rules mean that it’s unlikely to be covered by Medicare. According to the Alzheimer's Association, those on Medicaid only should be able to get coverage of the FDA-approved drug in most cases. But, even if Medicaid does cover it, patients would be responsible for a 20 percent copay – or about $5,300. Experts predict the total cost of Leqembi treatment can run upward of $90,000 a year, if you take infusions and laboratory tests into account.

An expensive treatment program is something to consider for the one in nine Americans who are over the age of 65 that have Alzheimer’s dementia. That number is expected to grow as the nation’s aging population continues to grow. The number of Americans 65 and older is projected to climb from 58 million in 2021 to 88 million by 2050. This has led to an increased focus on treatments and diagnostics for Alzheimer’s, like blood tests that can detect the disease.

Owlet and its baby monitoring devices are back in the good graces of the FDA. The company received clearance from the US regulator for its product BabySat, a medical-grade pulse-ox monitor designed as a wireless “sock” for newborns and babies. The win comes after the FDA ordered the Utah-based biotech company to stop selling its smart sock almost 18 months ago.

The FDA objection was based on the fact that the wearable had the capacity to relay a live display of a baby’s heart rate and oxygen levels, which is critical data that a doctor should interpret, especially in vulnerable populations. The tumultuous approval demonstrates “our technology is medical-grade,” Kurt Workman, Owlet CEO and co-founder said of the company's path to getting FDA approval. “We conducted several side-by-side accuracy comparisons to hospital monitors and that demonstrated Owlet is accurate." The device can alert a provider if any metrics are out of range, which can help to diagnose and prevent complications.

Owlet stripped out the blood oxygen and pulse tracking features and returned to the market just a few months later with the Dream Sock. The $299 wearable is available direct from the company and through a number of other retailers without a prescription, but it lacks the advanced features that set it apart from the rest of its rivals. Instead, it’s a pretty straightforward sleep tracker.

BabySat, on the other hand, is a prescription device. It integrates medical-grade pulse oximetry technology into a discreet wearable. It’s a noninvasive tool to measure how well oxygen is circulating to extremities in babies from 1 to 18 months.

Without a prescription, a rival medical-grade device can not be readily found on the market, given that BabySat is the first device of its kind to receive FDA approval. Creating a treatment plan with a doctor is especially valuable and useful to the parents of babies that have been diagnosed with heart defects or chronic conditions. If a newborn or baby does present with persistent low oxygen levels, quick intervention by medical professionals is needed to prevent life-threatening complications.

Owlet anticipates the product will be available in the US by the end of this year. The company declined to disclose pricing information for BabySat but did say that insurance options, including reimbursements and HSA/FSA eligibility, will likely be available at launch.

The office of Texas State Attorney General Ken Paxton has requested that Pfizer and several other companies turn over advertising data tied to the social media giant Meta. The lawsuit was filed after consumer data privacy concerns were raised by the state in its latest legal battle with Meta, according to a report by Law360. The Texas Attorney General claims that millions of Texas residents have had their private biometric data misappropriated over the past ten years.

The order requires the vaccine maker to share any records it holds regarding Meta’s use of facial recognition technology over claims that the company was collecting biometric data from Facebook users without their consent. This decree over Pfizer’s records follows a February 2022 filing against Meta by the Texas Attorney General that claimed “Facebook knowingly captured biometric information for its own commercial benefit” in order to “train and improve” its in-house facial recognition technology powered by AI. The Texas lawsuit cites Facebook founder and CEO Mark Zuckerburg’s commentary that photo tagging is “more important than every other [Facebook] feature put together” as evidence in their case against the company under a section that highlights its allegations against the company. The February 2022 petition against Meta over data privacy concerns came shortly after Facebook decided to discontinue its face recognition systems in 2021. Meta said its move to cut back on its facial recognition tech development was necessary because of the lack of regulator guidelines.

The Texas Attorney General has been aggressive in its pursuit of Meta’s data on the issue. The state has cast a wide net with its series of lawsuits, subpoenaing a number of other big-name companies affiliated with the company through its advertising arm. Pfizer is just one of many companies subpoenaed in the attempt to discover data incriminating Meta. Others ordered to turn over advertising data include Procter & Gamble, Home Depot, The New York Times, SmileDirectClub and Clarity Media Group. Although the exact investment value of Pfizer’s advertising deals with Meta are undisclosed, we do know the company’s “selling, general, and administrative expenses,” which include marketing and advertising, reached a whopping $34 billion in 2022.

Meta is hardly the only name in big tech being targeted by the Texas AG over data privacy concerns. Google is similarly facing the Texas Attorney General in court over its facial data collection practices. Last year, Google was sued by Texas for engaging in “years-long practices” of capturing biometric data from millions of Texans without consent. In that same year in a separate lawsuit with the state of Illinois, Google paid $100 million to settle a class action that accused the tech giant of violating the Biometric Information Protection Act. The case resembles the Texas suit filed against Meta, which claims the company violated Texas’ Capture or Use of Biometric Identifier Act. Confirmation that a violation of that specific Texas act by Meta can result in a penalty of up to $25,000 per violation of the law. So far, an infraction fine against the social media giant has not been determined.

Both Pfizer and the Texas AG office could not be reached to comment on the ongoing case.