FDA investigating death of child who received Sarepta's Elevidys
Elevate Your Investing Strategy:
Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
25 minutes ago
- Yahoo
Canaccord Genuity Reiterates Buy Rating on Fractyl Health (GUTS)
Fractyl Health, Inc. (NASDAQ:GUTS) is one of the 11 Best New Penny Stocks to Buy Right Now. On July 18, Canaccord Genuity reiterated its 'Buy' rating on Fractyl Health, Inc. (NASDAQ:GUTS) with a price target of $12. This decision came after the company had shared new data from its Phase 3 trial of its lead product candidate, Revita. A medical laboratory surrounded by advanced equipment, symbolizing the company's cutting-edge innovation in healthcare. Canaccord Genuity had follow-up discussions with several physicians following the data presented by Fractyl Health, Inc. (NASDAQ:GUTS) from the open-label group of its ongoing Phase 3 trial for Revita in weight maintenance at the American Diabetes Association meeting. These physicians who were consulted by the investment firm were all from large academic hospitals in the US. The physicians had different opinions on the mechanism behind the Revita procedure and the potential market size. However, they all agreed that controlled data is needed to fully assess the clinical profile. The physicians said the main concern is the durability of the effect. Canaccord pointed out that even conservative market share estimates from the physicians surpassed the firm's current modeling expectations. Canaccord Genuity expects Revita to reach 1% peak penetration in the weight maintenance population with a 60% probability of success. The investment firm projects that peak sales could reach $400 million in 2031. Fractyl Health, Inc. (NASDAQ:GUTS) is a metabolic therapeutics company focused on pursuing therapies that target root causes of obesity and type 2 diabetes. While we acknowledge the potential of GUTS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Best American Semiconductor Stocks to Buy Now and 11 Best Fintech Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
TechCrunch
27 minutes ago
- TechCrunch
Fed up with brands that use corn syrup and skim milk, this mother developed her own ‘clean' baby formula
When Esther Hallam welcomed her daughter, Nara, into the world, she faced the challenge of searching for trustworthy brands that offered high-quality, organic infant formula in the U.S. Despite being available for nearly 160 years, the quality of infant formula options in the U.S. is still lacking, she believes. Many manufacturers opt for skim milk to cut costs, which allows them to add oils to meet nutritional requirements. Several formulas contain palm oil, soy, and corn syrup, which aren't recommended for infants due to their potential health risks. For instance, research has linked corn syrup to an increased risk of obesity, while palm oil has been shown to decrease calcium and fat absorption. 'I became fixated by the fact that there wasn't a good, organic infant formula that I trusted, that I wanted to feed my daughter in the United States, which is a first-world country,' Hallam told TechCrunch. For the past seven years, Hallam has been developing her own organic, whole-milk infant formula from scratch, with the help of scientists and pediatric nutritionists. Today marks the official launch of Nara Organics, which meets both European and U.S. safety standards, and is FDA-registered and USDA-certified. Most importantly, the formula is free from palm oil, soy, corn syrup, maltodextrin, and genetically modified organisms (GMOs), providing a clean option for conscientious parents looking to nourish their babies with the best possible ingredients. Nara Organics claims to have the highest percentage of milk fat of any formula sold in the U.S. It also has the lowest percentage of plant-based oils, as the use of whole milk means that less oil is needed to achieve the correct fat content. The ingredient list on the package includes an 'organic vegetable oil blend' made up of organic sunflower, coconut, and rapeseed oils, which provide essential fatty acids that support healthy development. Techcrunch event Tech and VC heavyweights join the Disrupt 2025 agenda Netflix, ElevenLabs, Wayve, Sequoia Capital — just a few of the heavy hitters joining the Disrupt 2025 agenda. They're here to deliver the insights that fuel startup growth and sharpen your edge. Don't miss the 20th anniversary of TechCrunch Disrupt, and a chance to learn from the top voices in tech — grab your ticket now and save up to $675 before prices rise. Tech and VC heavyweights join the Disrupt 2025 agenda Netflix, ElevenLabs, Wayve, Sequoia Capital — just a few of the heavy hitters joining the Disrupt 2025 agenda. They're here to deliver the insights that fuel startup growth and sharpen your edge. Don't miss the 20th anniversary of TechCrunch Disrupt, and a chance to learn from the top voices in tech — grab your ticket now and save up to $675 before prices rise. San Francisco | REGISTER NOW Image Credits:Nara Organics While there are several brands with organic formulas, such as Bobbie and ByHeart, these products are manufactured in the U.S. In contrast, Nara Organics chose not to produce its formula in American facilities, potentially due to previous issues with Cronobacter contamination, a germ that can survive in dry foods. In recent years, there have been several recalls of baby formula linked to outbreaks of Cronobacter. This is why the company prefers to manufacture its formula in Germany, which just so happens to be the birthplace of powdered infant formula. Chief marketing officer Meika Hollender explained to TechCrunch that the company's manufacturing partner utilizes technology 'that doesn't exist anywhere else in the world,' she said. 'A critical piece of infant formula, in terms of its shelf life, is how much oxygen gets into the can while you're sealing it. So if you go to facilities in the U.S., they're open. When you're filling, canning, and sealing the can, they're just sort of out in the open air of the facility. And at our facility, the cans actually go into this chamber that has no oxygen in them,' Hollender said. Nara has secured a total of $32 million from AlleyCorp, BBG Ventures, Corazon Ventures, Gingerbread Capital, and Torch Capital. Additionally, the company has attracted attention from high-profile celebrity investors, including tennis superstar Serena Williams, 'Jane the Virgin' actress Gina Rodriguez, and the creators of 'Nobody Wants This,' Erin and Sara Foster, among others. Nicky Hilton, fashion designer and philanthropist, is also an investor and advisor. 'I breastfed all of my three children, but they also all had formula,' Hilton told us. 'Every baby and parent is different, and not all mothers are able to breastfeed due to medical, physical, or personal reasons. I think there's so much judgment and unnecessary pressure about breastfeeding… It's really exciting to be a part of an innovative brand that is disrupting the baby formula market.' With this support, Nara Organics could position itself as a key player in the organic formula market, which was valued at approximately $20.7 billion in 2023 and is expected to reach $37 billion by 2032. Image Credits:Nara Organics The formula is now available for purchase on the company's website. Customers can choose the starter bundle for $36, which includes 2 cans. Alternatively, they can sign up for a subscription that delivers either 4 or 6 cans every 4 weeks, priced at $136 or $243, respectively. Each can makes about 25 4-ounce bottles. It can also be purchased through the company's free mobile app, which Hallam launched in 2018. The app is designed to assist users in tracking essential aspects of infant care, including monitoring baby feeding times, keeping a log of wet and soiled diapers, and tracking tummy time exercises. As part of its launch, the company is donating over 1,400 cans of infant formula to the Good+ Foundation, a nonprofit organization working to end multi-generational poverty by supplying essential items and services to under-resourced parents and caregivers.
The Verge
28 minutes ago
- The Verge
The dangerously blurry line between wellness and medical tech
Few things scratch my brain like a good beef. Kendrick vs. Drake. Justin Baldoni vs. Blake Lively. On my beat, it's usually two companies fighting over health tech patents. So-and-so copied a feature from so-and-so. The latest dispute on my radar is all about semantics. More specifically, the exact meaning of wellness. Let me catch you up. On July 15th, the Food and Drug Administration (FDA) sent Whoop a letter. In it, the FDA declared that Whoop — maker of a niche fitness tracker favored by elite athletes — had crossed a line. Its new Blood Pressure Insights feature, the regulator said, was being marketed to customers without undergoing the proper clearance process. In response, Whoop pulled out the W word: wellness. In the world of health and wearable tech, 'wellness' is sort of like a 'get out of jail free' card. Some advanced health features, like EKGs and atrial fibrillation notifications, require regulatory clearance before consumers can use them. These features could be interpreted as diagnostic in nature or prompt a person to make a medical decision. Others, like step tracking and blood oxygen measurements, don't require FDA oversight at all. They're simply meant to make living a healthy life easier by helping you visualize certain measurable markers. Those features fall under the wellness umbrella. They're 'just for fun.' Whoop's Blood Pressure Insights feature, however, lies in murkier territory. The way Whoop's feature works is that a user takes readings with a regular blood pressure cuff for calibration. Once that process is complete, Whoop says its tracker uses metrics like 'heart rate, heart rate variability, and blood flow patterns during sleep' to give an estimate of a person's systolic and diastolic blood pressure each morning. The FDA contends that 'providing blood pressure estimation is not a low-risk function' and that a blood pressure estimate inherently implies you're diagnosing hypo- or hypertension. In a statement, Whoop says it 'respectfully disagree[s]' and that this particular feature is more akin to tracking your sleeping respiratory rate. Under the wellness umbrella, Whoop argues it's able to bring an innovative feature to the masses more quickly. Whoop and the FDA both have points. It's not a stretch to think that a user may get a few 'high' blood pressure estimates, assume they have high blood pressure, and make health decisions informed by that assumption. At the same time, it's clearly labeled as a beta feature, and similar 'diagnostic adjacent' features are available without FDA regulation. I've lost count of how many sleep trackers claim to track 'breathing disturbances.' That may not be explicitly marketed as a sleep apnea detection metric (that would require FDA clearance), but that's semantics. The obvious reason to include it is to flag when a person might want to check themselves for sleep apnea. The crux of it all is identifying high- and low-risk features for causing harm. Many cases are clear-cut. Natural Cycles, for example, is a period tracking app that claims you can use it as digital contraception using temperature data from wearables like the Oura Ring. It's obvious that a regulatory body should vet a high-stakes feature like that. On the flip side, Samsung's new Antioxidant Index feature for its Galaxy Watch 8 is a silly metric that tells you whether you've eaten enough fruits and veggies. Even if it's inaccurate as hell (I was able to fool it by scanning a Cheez-It), it's not likely to harm your health. Where the FDA's current process falls short is the increasing number of features that lie somewhere in the middle. Take the Oura Ring. A friend just asked me whether they should get one based on a TikTok video. In said video, celebrity DJ Dillon Francis says the main reason he has an Oura Ring is because it predicts when he's getting sick. This is the Symptom Radar feature, which, in simple terms, flags when you might be getting sick — and it's based on real clinical research conducted during the COVID-19 pandemic. It sounds diagnostic, which requires FDA clearance. But it's not. It's considered a wellness feature because it doesn't tell you what you're falling ill with — just that you might be showing 'early signs of a health change.' And while there's a distinct difference between a diagnosis and a heads-up, it can feel awfully similar to a layperson. Also, Whoop isn't the only company exploring blood pressure tech. Samsung has a similar feature that's unavailable in the US, as it hasn't been cleared by the FDA. According to Bloomberg, Apple has also been working on an Apple Watch feature that flags when your blood pressure spikes above your baseline, but it reportedly won't spit out direct readings like a continuous glucose monitor would — possibly to avoid FDA clearance as a 'wellness' feature. Perhaps that means it's time we acknowledge that wellness isn't an innocuous word anymore. Beyond blood pressure, Samsung and Apple are also widely rumored to be working on blood glucose monitoring features, where the stakes for diabetics could be sky-high. If or when those features do become available, it's possible that companies will adjust how they work to more broadly fit under a wellness label. For instance, instead of glucose readings, you get a trend line or score. I'm skeptical of the average person being able to discern the nuance when even seasoned tech journalists sometimes struggle with the correct verbiage. Maybe it seems silly to sound the alarm over semantics. But as politicians advocate for greater wearable adoption, the stakes have never been higher. In a better, ideal world, companies would abolish phrases like 'clinically proven' or 'medical grade' from marketing. The FDA would figure out a clearer framework for the design of a wellness feature versus a medical one. But we don't live in an ideal world — and that means it's up to the consumer to know the difference. Frankly, that's not going so well. Perhaps that means it's time we acknowledge that wellness isn't an innocuous word anymore. Posts from this author will be added to your daily email digest and your homepage feed. See All by Victoria Song Posts from this topic will be added to your daily email digest and your homepage feed. See All Analysis Posts from this topic will be added to your daily email digest and your homepage feed. See All Features Posts from this topic will be added to your daily email digest and your homepage feed. See All Fitness Posts from this topic will be added to your daily email digest and your homepage feed. See All Gadgets Posts from this topic will be added to your daily email digest and your homepage feed. See All Health Posts from this topic will be added to your daily email digest and your homepage feed. See All Science Posts from this topic will be added to your daily email digest and your homepage feed. See All Wearable
