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Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailDr. Scott Gottlieb on UnitedHealth hack: Very pervasive across the entire health care systemFormer FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the latest developments on the UnitedHealth hack, the impact on the U.S. health care system, and more.
Persons: Scott Gottlieb Organizations: FDA
We are taking advantage of Friday's sell-off in Abbott — shares are down more than 4% in morning trading — to increase our exposure to the medical device maker. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB.
Persons: Jim Cramer's, Abbott —, Abbott, it's, ABT, Jim Cramer, Jim Organizations: Abbott Laboratories, ABT, Abbott, Federal Trade Commission, U.S . Department of Agriculture, Food and Drug Administration, FDA, CNBC
The Food and Drug Administration on Thursday approved the first-ever treatment for a common and potentially deadly form of liver disease that affects millions worldwide. Novo Nordisk and Eli Lilly are testing their respective blockbuster weight loss injections as treatments for the same kind of liver disease, called nonalcoholic steatohepatitis, or NASH. Madrigal's drug, which will be marketed as Rezdiffra, is specifically approved to treat patients with NASH who also have moderate-to-advanced liver scarring. NASH is a serious form of liver disease characterized by excess fat buildup and inflammation in the liver and can lead to liver scarring, also known as fibrosis, along with liver failure and liver cancer. Roughly 6 million to 8 million people in the U.S. have NASH with moderate-to-advanced liver scarring, according to an estimate cited by the FDA.
Persons: Madrigal, Eli Lilly, NASH, Nikolay Nikolov, Rezdiffra Organizations: Madrigal Pharmaceuticals, Drug Administration, Pharmaceuticals, Novo Nordisk, FDA, Immunology Locations: U.S
KQED/KFF Health News —A much-awaited treatment for postpartum depression, zuranolone, hit the market in December, promising an accessible and fast-acting medication for a debilitating illness. Miriam McDonald, who developed severe postpartum depression and suicidal ideation after giving birth in late 2019, battled Kaiser Permanente for more than a year to find effective treatment. Her doctors refused to prescribe brexanolone, the only FDA-approved medication specifically for postpartum depression at the time. Insurers’ policies for zuranolone will be written at a time when the regulatory environment around mental health treatment is shifting. In the meantime, Burkhard said, patients suffering from postpartum depression should not hold back from asking their doctors about zuranolone.
Persons: , Meiram Bendat, , Joy Burkhard, KP’s, Kaiser, Miriam McDonald, ” McDonald, KP, Nico, Keith McDonald, brexanolone, “ Kaiser Permanente, ” “ Kaiser, Burkhard, “ It’s, Dr, Sanjay Gupta, ” Burkhard Organizations: KQED, KFF, brexanolone, FDA, zuranolone, OB, Center, Maternal Mental, Kaiser Permanente, NPR, Department of Labor, Maternal Mental Health, Medicaid, Cal, U.S . Department of Labor, CNN, CNN Health, KFF Health Locations: , “ Kaiser, California
But since then WW shares have suffered heavy selling, dropping to a new 52-week low on Thursday. The stock, due to its debt load and short interest, as well as the general anxiety about the impact of the new weight loss drugs, is subject to heightened volatility. In the memo, Sistani told employees she wanted "to take a moment to address some of the breathless media coverage." WW shares closed at $1.87 on Thursday. It noted that WW was among companies from the weight loss industry involved in the TV event.
Persons: Oprah Winfrey, Sistani, Eli Lilly, Sima Sistani, Guggenheim, Oprah, Winfrey Organizations: CNBC, Nordisk, Guggenheim Partners, Guggenheim, WeightWatchers Clinic, FDA, WeightWatchers, National Museum of, ABC
Let's analyze how to trade a drug stock that's made a terrific comeback and could have more upside from here. But there's a catch: The price of call options have become too expensive given the rally, so we need to think of lower-cost trade to bet on upside from here. Now that it's traded off those lows and started to outperform the markets, I have a follow-up trade. The trade Options on BMY currently are very expensive, so buying calls are out of the question. BEFORE MAKING ANY FINANCIAL DECISIONS, YOU SHOULD STRONGLY CONSIDER SEEKING ADVICE FROM YOUR OWN FINANCIAL OR INVESTMENT ADVISOR.
Persons: that's, BMY, it's Organizations: Myers Squibb, underperformance, pharma, Bristol Myers Locations: Bristol
AdvertisementShipments of the nicotine pouches in the US in 2023 were up 62% year-over-year. Zyn pouches have found favor with everyone from high-powered Wall Street traders to Tucker Carlson and GOP lawmakers. But after not using nicotine for a while, he wasn't prepared for the hit he got when he popped a 6 mg pouch of Zyn. AdvertisementPalmer sees using Zyn as an important part of his ritual around essential work. "If I could go back and never start using nicotine, I would."
Persons: Clay Coomer, Coomer, Coomer isn't, , Clay, Zyn, Philip Morris, Tucker Carlson, Raymond Niaura, Niaura, there's, Nate Palmer, wasn't, Palmer, he's, it's, I've, Chandler, I'm, Sam Dashiell, Dashiell, JUULs Organizations: Service, Business, Philip Morris International, Swedish, GOP, New York University, FDA, Labs
64 federal job categories pay upwards of $200,000, with some reaching $400,000. AdvertisementMany people enter federal roles for job security, not for the money. Data from the US Office of Personnel Management indicates 64 federal job categories have positions that pay over $200,000 — and some pay as much as much as $400,000. AdvertisementThere are currently 55 open positions in this category, with the highest role listed with a starting salary of $180,564. According to OPM, there are currently 319 federal employees in this job category who make over $200,000.
Persons: , usajobs.gov Organizations: Service, Management, Federal Deposit Insurance Corporation, Department of, IT Management, NASA, FDA, Fish and Wildlife Service, Forest Service, Natural Resources Conservation Service, General Engineering, Marshall Space Flight, HR Management, National Science Foundation
Delta-8 THC, or delta-8 tetrahydrocannabinol, is one of more than 100 chemical compounds found in the cannabis sativa plant. That’s at least one or two students in every average-sized high school class who may be using delta-8. Most of the participants were about 17 years old, so the study may not fully represent how many younger teens are using delta-8. There has been a general concern that the number of students using delta-8 has been growing, according to an editorial published Tuesday alongside this study. Calls to America’s Poison Centers about delta-8 products spiked 82% from 2021 to 2022, the group said in a recent report, with 3,358 exposures managed in 2022.
Persons: , Adam Leventhal, “ Dr, Nora Volkow, ” Leventhal, Jennifer Whitehill, Kelly Dunn, Renee Johnson, Harlow et, Scientists don’t, Dr, Sanjay Gupta Organizations: CNN —, USC Institute for Addiction Science, Midwest, National Institute on Drug, University of Massachusetts Amherst, Johns Hopkins University, National Cannabis Industry Association, Scientists, Research, Get CNN, CNN Health, Centers
Read previewThe CEO of the Enhanced Games — dubbed the "Olympics on steroids" — said there will be on-site stewards prepared to deal with any drug overdoses at the sporting event. "It's a risk-management framework," said Aron D'Souza, who founded the Peter Thiel-backed sporting event, in a conversation with Business Insider. The controversial sporting event, which organizers say could be held for the first time next year, is pushing the boundaries of what is acceptable in athletics. "The Enhanced Games promote themselves as the 'Olympics of the future' and state that they will 'pay athletes fairly,'" she told BI. But Backhouse said she is most concerned about the message the Enhanced Games sends to the next generation of athletes.
Persons: , Aron D'Souza, Peter Thiel, that's, D'Souza, Sue Backhouse, Backhouse, D'Souza's Organizations: Service, Business, Doping Agency, Reuters, NFL, Carnegie School of Sport, Leeds Beckett University
And some people opt to get their caffeine through energy drinks or caffeine pills. In rarer scenarios, an overconsumption of caffeine can lead to a state called caffeine intoxication or caffeine overdose. Caffeine intoxication occurs when a person has dangerously high levels of caffeine in the system. While rare, there is always a potential for caffeine intoxication if a person is drinking irresponsibly. Caffeine intoxication is more than the headache you get from drinking too much expresso.
Persons: Erin Palinski, Wade, Oleg Breslavtsev, Nima Majlesi, Majlesi, , you’ve, you’re, Jocelyn Solis, Moreira Organizations: CNN, National Coffee Association, US Food and Drug Administration, EKP Nutrition Communications, Staten Island University Hospital, Palinski Locations: New Jersey, New York
Veterinarians told Business Insider which pet products they don't think are worth splurging on. Business Insider asked veterinarians to highlight a few pet products that can be a waste of money. Pet multivitamins aren't always necessaryPets don't usually don't need multivitamins to stay healthy. bbearlyam/ShutterstockIt may be tempting to splurge on a fancy wardrobe for your dog, but most pets don't need clothes. "Pets don't need fancy clothes or clothing at all," said Barrack.
Persons: , John Kershner, Shutterstock Stacy Choczynski Johnson, Johnson, Santi Nanta, Jennifer McCallum, Heather Venkat, Venkat, Chew, Richardson, Rachel Barrack, Barrack Organizations: Service, Business, Pumpkin Pet Insurance, FDA, Veterinary Oral Health, Animal Acupuncture
But a big problem persists as long as the coronavirus continues to spread: long COVID. Long COVID is a condition involving new, returning or ongoing health problems four or more weeks after initial coronavirus infection. “The long COVID community and the COVID cautious community are pretty furious about it,” Hennessy says. And of the people who were aware of long COVID, more than 20% said they at least somewhat agreed with the statements “those with Long COVID may just be depressed” and “Long COVID symptoms are often just the normal aches and pains of life.”“They’re told that their brain fog or other symptoms are not real, and that’s demoralizing,” Rylance said. Young adults and children can also have long COVID, with more than 1% of kids ever having long COVID as of 2022, according to a national survey.
Persons: Long, Long COVID, , Paul Hennessy, ” Hennessy, Mandy Cohen, didn’t, Hennessy, , ” Jamie Rylance, hadn’t, ” “ They’re, that’s, ” Rylance, they’re, , it’s, Lynn Goldman Organizations: World Health Organization, Washington , D.C, Survey, Centers for Disease Control, CDC, PBS, COVID, CDC’s National Center for Health Statistics, U.S . Research, New England, of Medicine, Milken Institute School of Public Health, George Washington University Locations: U.S, Washington, Washington ,
Now, the company is betting on cancer drugs to help it regain its footing after a rocky year marked by the rapid decline of its Covid business. That $43 billion Seagen acquisition doubled Pfizer's oncology drug pipeline to 60 different experimental programs. Some analysts noted that it might take a few years for some of Pfizer's cancer drugs in mid-stage development to show pivotal clinical trial data and become less risky. Revenue from the blockbuster breast cancer drug Ibrance and prostate cancer treatment Xtandi, which Pfizer shares with Astellas Pharma, has declined over the past year. They are among the most expensive prescription drugs in the U.S. Before the Seagen deal, 94% of Pfizer's cancer products were small-molecule drugs.
Persons: Wall, Seagen, Chris Boshoff, Boshoff, David Ryder, Trung Huynh, Joe Biden's, Chris Schott, Suneet Varma, RemeGe, Merck, Padcev, Guggenheim, Pfizer's, Pfizer hasn't, Dr, Mikael Dolsten, Irfan Khan Organizations: Nurphoto, Getty, Pfizer, Astellas Pharma, Guggenheim, Bloomberg, UBS, Medicare, Drug Administration, FDA, ADC, JPMorgan, Drugs, CNBC, CVS Pharmacy, Los Angeles Times Locations: Covid, Bothell , Washington, U.S, biologics, China, Eagle Rock , California
SignosFounded in 2018, Signos uses continuous glucose monitors, or CGMs, and an artificial intelligence-powered app to help people better understand their metabolisms. But Signos' CGM system is meant for average consumers, so it is not intended for diabetes management. The Signos app walked me through the process step by step, offering a one-minute video and a series of GIFs I could watch. Another activity had me try and guess what I thought my glucose levels were at different points throughout the day. After eating a meal, I would often get a "Fast Rise" notification from my Signos app, which indicates that a glucose spike is occurring.
Persons: Ashley Capoot, I've, Signos, Dexcom, Sharam Fouladgar, you've, it's Organizations: CNBC, Abbott Laboratories, Centers for Disease Control, U.S . Food, Drug Administration, Dexcom Ventures, Bluetooth Locations: U.S, Mercer
The label expansion may improve insurance coverage for Wegovy, which costs more than $1,300 per month out of pocket before any discounts. Many insurers, including Medicare, don’t cover drugs for weight loss, leaving patients scrambling to afford them. “This patient population has a higher risk of cardiovascular death, heart attack and stroke,” he added. More studies need to be done to show whether there are heart benefits for people who haven’t had a cardiac event. Wegovy continues to be in shortage, along with other GLP-1 medicines, as drugmakers struggle to keep up with demand.
Persons: CNN — Wegovy’s, , Dr, Harlan Krumholz, hasn’t, Eli Lilly, Wegovy, John Sharretts, haven’t, it’s, Sanjay Gupta, Jody Dushay, Beth, Dushay, Novo, Doug Langa, Organizations: CNN, US Food and Drug Administration, Yale University, Yale New Haven Hospital, Novo Nordisk, Diabetes, , CNN Health, Beth Israel Deaconess Medical Center, Harvard Medical School, Novo Nordisk’s, North America Operations
Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move. The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said. It's another setback for Eli Lilly, which is racing to compete with Biogen and Eisai. In 2021, the FDA approved an earlier, ill-fated Alzheimer's drug called Aduhelm from Biogen and Eisai, despite a negative recommendation from the agency's advisory panel.
Persons: Eli Lilly, Eli Lilly's, Leqembi, Anne White Organizations: and Drug Administration, FDA Locations: Indianapolis , Indiana, Biogen
Amylyx said Friday it would discuss its plans for Relyvrio with patients and the FDA, which “may include voluntarily withdrawing” the drug. The latest company study showed that the drug did not slow the disease compared with a dummy treatment. Amylyx’s medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable proof that they work. That commitment seemed to reassure FDA's advisers who voted in favor of the drug's approval, despite the questionable data. In the months before the decision the FDA faced intense pressure from ALS patients, advocates and members of Congress.
Persons: Lou Gehrig’s, Amylyx, , , Relyvrio Organizations: WASHINGTON, Drug Administration, Amylyx Pharmaceuticals, Relyvrio, FDA, Cambridge, Amylyx Pharmaceuticals Inc, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S
Injection pens of Novo Nordisk's weight-loss drug Wegovy are shown in this photo illustration in Oslo, Norway, Nov. 21, 2023. The approval also demonstrates that weight loss drugs have significant health benefits beyond shedding unwanted pounds and regulating blood sugar. The FDA said Wegovy patients should use Wegovy in addition to a reduced calorie diet and increased physical activity. Novo Nordisk expects to receive a similar Wegovy approval in the EU this year. The study tested Wegovy in roughly 17,500 people with obesity and heart disease but who did not have diabetes.
Persons: John Sharretts, Ozempic, Wegovy, Eli Lilly, Zepbound Organizations: Drug Administration, Novo Nordisk, Diabetes, FDA's Center, Drug, Research, FDA, Nordisk Locations: Oslo, Norway, Danish, U.S
Why have there been so many product recalls lately? Data shows that product recalls increased 11% from 2022 to 2023, reaching a seven-year high. download the app Email address Sign up By clicking “Sign Up”, you accept our Terms of Service and Privacy Policy . AdvertisementWhat's with all the product recalls lately? This story is available exclusively to Business Insider subscribers.
Persons: , Joe's Organizations: Service, FDA, Business
CNN —A clinical trial’s encouraging results won US Food and Drug Administration breakthrough therapy status for an LSD formulation to treat generalized anxiety disorder, Mind Medicine Inc. announced Thursday. Generalized anxiety order is characterized by excessive, ongoing thoughts that are difficult to control and interfere with day-to-day activities. Anxiety is one of the most common mental disorders in the US, according to the Anxiety and Depression Association of America. The MM120 study, however, was accomplished without the use of psychotherapy during the session. So that’s a critical difference.”Most adverse effects in the study were rated as mild to moderate by participants, occurring mostly on the day of the study, Karlin said.
Persons: , , Daniel Karlin, MindMed’s MM120, ” Karlin, buspirone —, Karlin, David Nutt, Nutt, Dr, Gabriella Gobbi, Timothy Leary, Richard Alpert, Eddie Adams, Leary, Richard Nixon Organizations: CNN, US Food and Drug Administration, Medicine Inc, Tufts University School of Medicine, FDA, Depression Association of America, Unit, Imperial College London’s, McGill University Health Centre, Canada, Therapeutics, Mental Health, Harvard University, Harvard, League for Spiritual, Woodstock Locations: Boston, United States, Montreal, New York, Vietnam
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFmr. FDA Commissioner weighs in on Medicare's involvement in GLP-1 pricesDr. Scott Gottlieb, Former FDA Commissioner, weighs in on the impact of GLP-1s on Medicare and the healthcare sector at large.
Persons: Scott Gottlieb Organizations: FDA, Medicare Locations: GLP
Ground cinnamon sold by U.S. discount retailers is contaminated with high levels of lead and should be discarded, federal health officials said Wednesday. Cinnamon products included in the agency's safety alert include the La Fiesta brand sold by La Superior and SuperMercados; Marcum brand sold by Save A Lot stores; MK brands sold by SF Supermarket; Swad brand sold by Patel Brothers; El Chilar brand sold by La Joya Morelense; and Supreme Tradition brand sold by Dollar Tree and Family Dollar stores. Dollar Tree and Family Dollar stores have removed the cinnamon from their store shelves, a company spokesperson said. No illnesses or other health effects have been reported in connection with the new ground cinnamon alert, the FDA said. The FDA monitors foods for lead levels, but the U.S. government doesn’t broadly limit lead in food products.
Persons: Patel, La Joya Morelense Organizations: U.S, U.S . Food, Drug Administration, Fiesta, La Superior, SF, Patel Brothers, La, FDA, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S
Starting this fall, however, all the flu shots distributed in the United States will probably contain only three strains, and the change is because of Covid-19. It’s not quick or easy to change how flu vaccines are manufactured, and those changes require regulatory review and approval. The committee is meeting Tuesday to discuss next steps and vote on flu vaccine recommendations for the fall. “Anytime these flu vaccines are being produced, they are – depending on which vaccines you are talking about – using live or attenuated virus, and you do have to grow it,” she said. But as the authors note, any such change would require testing and regulatory approval, and for that reason, it’s not likely we’ll see the return of four-strain flu shots any time soon.
Persons: Covid, Yamagata, It’s, We’ve, , Paul Offit, Offit, Jodie Guest, Dr, Sanjay Gupta, Arnold Monto, Maria Zambon, Jerry Weir, it’s Organizations: CNN, World Health Organization, Food and Drug Administration, Vaccine Education, Children’s Hospital of Philadelphia, Biological Products Advisory, WHO, Emory University’s Rollins School of Public Health, Get CNN, CNN Health, New England, of Medicine, UK Health Security Agency Locations: United States, Victoria, Yamagata
This means Stelo will be accessible to people who do not have insurance coverage for CGMs, Dexcom said. There are more than 25 million Type 2 diabetes patients in the U.S. that do not use insulin, according to the release from Dexcom. Dexcom shared Stelo's name, as well as the fact that the device had been submitted to the FDA for review in February. Jake Leach, chief operating officer at Dexcom, told CNBC in February that Stelo will have its own unique platform and branding. Leach said as Dexcom is able to demonstrate the benefits of Stelo, the company believes insurance companies will eventually pay for it.
Persons: Dexcom, it's, Dr, Jeff Shuren, Jake Leach, Stelo, It's, Leach Organizations: U.S . Food, Drug Administration, FDA's Center, Devices, Radiological, FDA, CNBC, CNBC PRO Locations: U.S
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