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An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023. Most doses of Eli Lilly 's highly popular weight loss drug Zepbound and diabetes counterpart Mounjaro will be in short supply through the second quarter of this year as demand jumps, according to an update on the Food and Drug Administration's drug shortage database on Wednesday. All doses of Zepbound and Mounjaro besides the 2.5-milligram versions of both treatments are in a shortage. "We recognize this situation may cause a disruption in peoples' treatment regimens and areworking with purpose and urgency to help meet the surge in demand," an Eli Lilly spokesperson said in a statement to CNBC. The company expects its investments in manufacturing and supply capacity "to progressively increase production of our medicines throughout 2024 and beyond," they added.
Persons: Eli Lilly’s, Eli Lilly Organizations: Food, Novo Nordisk, CNBC Locations: New York City, U.S
Abbott Laboratories Why we own it : Abbott is a high-quality medtech company growing at a fast clip. As Abbott's organic sales growth continues to shine, the market will realize both concerns are overblown. We also love that EPS results on Tuesday came in above the range management had forecasted — a classic case of under-promising and over-delivering. ABT YTD mountain Abbott Laboratories YTD Organic growth was very strong, up nearly 11%, marking the fifth consecutive quarter of double-digit increases. In diagnostics, where we see the impact of the decline in Covid testing sales, organic sales increased 5.4% year over year.
Persons: , Abbott, Edwards, Robert Ford, necrotizing, Ford, they've, Jim Cramer's, ABT, Jim Cramer, Jim Organizations: Abbott Laboratories, Revenue, Abbott, Libre, Charitable Trust, ABT, Management, NEC, Protality, TBIs, CNBC, Abbott Labs Locations: U.S
CNN —The US Food and Drug Administration is warning that dangerous counterfeit versions of Botox have been identified in multiple states, putting the safety of consumers at risk. The incidents of counterfeit Botox being administered to consumers appear to be connected to products that have been purchased from unlicensed sources and then administered by either unlicensed or licensed providers. The counterfeit Botox products may be identified by the lot number C3709C3 found on the outer carton and vial, the FDA said. Counterfeit botox has been found in several states. Most often, when counterfeit Botox is sold, “the injector knows they’re purchasing something counterfeit,” Sung said.
Persons: Washington –, Botox, Lavanya Krishnan, Arya Derm, ” Krishnan, Krishnan, Allergan, , , Jimmy Sung, you’re, can’t, ” Sung, Michael Cameron, Cameron, ” Cameron, Sung, “ I’m, I’ve, Steven Williams, ” Williams, Dr, Sanjay Gupta, Cynthia Elliott, ” Elliott Organizations: CNN, Food and Drug Administration, FDA, US Centers for Disease Control, CDC, American Board of Cosmetic, Revance Therapeutics, Merz Aesthetics, Tribeca Aesthetics, Cameron Dermatology, Mount Sinai Health, American Society of Plastic Surgeons, , CNN Health Locations: – Colorado, Florida , Illinois , Kentucky , Nebraska , New Jersey , New York , Tennessee, San Francisco, United States, New York City, New York, Florida
But too much of supplements, including fish oil and vitamin D, can be harmful. A toxicologist shared the side effects of overdoing some of the most popular supplements. AdvertisementChilcott shared the long-term risks of taking too much of some of the most popular supplements. You're unlikely to get symptoms from taking too much vitamin D if you're taking less than 250 mcg a day, according to the ODS. Of all the supplements Chilcott spoke about, he said this was the one that's the most potentially risky, but only at very high doses.
Persons: , Rob Chilcott, Chilcott, it's Organizations: Service, University of Hertfordshire, FDA, Cleveland Clinic, BI, US Food and Drug Administration
As a dietary supplement, melatonin is not approved by the US Food and Drug Administration for safety, effectiveness or labeling before it is sold to the public. The council’s action follows recent reports of a massive rise in accidental ingestions of melatonin by children and an April 2023 study that found 25 products labeled as melatonin gummies contained dangerous levels of the hormone. Melatonin gummies were involved in nearly 5,000 of those cases. While the vast majority of unsupervised melatonin ingestions did not result in hospitalization, the number of accidental ingestions by children 5 and under may be underestimated, the report said. New and improved labelsThe council guidelines call for new labels that warn consumers about the danger of drowsiness after taking a melatonin supplement.
Persons: , , Pieter Cohen, ” Cohen, it’s “, Cohen, Catherine McQueen, ” Dr, Cora Collette Breuner, “ It’s, Breuner, Amanda Musa Organizations: CNN, Council for Responsible Nutrition, US Food and Drug Administration, Cambridge Health Alliance, US Centers for Disease Control, Prevention, CDC, Food and Drug Administration, Getty, Seattle Children’s Hospital, University of Washington Locations: Somerville , Massachusetts, Seattle
Sales of some Eli Lilly drugs — including its best-selling product last year — appear to be softening, according to Wall Street analysts. JPMorgan flagged similar trends for Trulicity, which led all Lilly drugs with $7.13 billion in sales for all of 2023. The thesis is predicated on Eli Lilly growing faster than the broader pharmaceutical industry for years to come. Over the past three years, shares of Eli Lilly have soared nearly 300%, compared with a 24% gain for the S & P 500 . A box of the drug trulicity, made by Eli Lilly Pharmaceutical, sits on a counter at a pharmacy in Provo, Utah, January 9, 2020.
Persons: Eli Lilly, Wells, Lilly, Mounjaro, Jim Cramer, tirzepatide, Zepbound, Eli Lilly's, Novo, Wegovy, drugmaker, Jim Cramer's, Jim, Eli Lilly Pharmaceutical, George Frey Organizations: Wall Street, JPMorgan, Club, Novo Nordisk, Novo, BMO Capital Markets, Drug Administration, FDA, The Club, CNBC Locations: Wells Fargo, Trulicity, Tirzepatide, Danish, Lilly, Provo , Utah
Adderall supply issues, which began in October 2022, are making the medication more expensive. The Biden Administration said it's focused on strengthening manufacturing supply chains for Adderall. AdvertisementIt's been 18 months since the US Food and Drug Administration announced an Adderall shortage. The prescription fill rate for ADHD medications fell from 44.5% in December 2022 to 40.7% in February 2023, the study found. Have you been impacted by the Adderall shortage or high prescription drug costs?
Persons: it's, , It's, Biden, Biden's, Joe Biden's, Adderall —, aren't, Dr, David Goodman Organizations: Biden Administration, Service, Food and Drug Administration, KFF, Kaiser Family Foundation, Business, Drug, Biden's Administration, Department of Health, Human Services, Defense, FDA, CNN, USA, DEA, USA Today, Johns Hopkins University, Medscape Medical, Government
"Nutrition facts" style labels for internet plans are finally a reality. As of Wednesday, the FCC now requires internet providers to break down costs and services for customers. That includes companies that provide both home, or fixed, internet services, as well as mobile broadband. AdvertisementAnd the labels aren't just designed for new customers — internet service providers must also make them available to current customers in their online account portals and provide the label when a customer asks for it. "The labels are modeled after the FDA nutrition labels and are intended to help consumers comparison shop for the internet service plan that will best meet their needs and budget."
Persons: Organizations: FCC, Service, Federal Communications Commission, Reuters, Google, Verizon
“It would be about 25 years before all the PFAS leave your body.”Testing your waterWhat can consumers do right now to limit the levels of PFAS in their drinking water? Filtering your waterIf PFAS levels are concerning, consumers can purchase an under-the-counter water filter for their tap. “The water filters that are most effective for PFAS are reverse osmosis filters, which are more expensive, about in the $200 range,” Andrews said. Reverse osmosis filters can remove a wide range of contaminants, including dissolved solids, by forcing water through various filters. PFAS in food and your homeDrinking water is not the only way PFAS enters the bloodstream.
Persons: Melanie Benesh, , ” Jane Hoppin, , Andrews, PFAS, ” Andrews Organizations: CNN, Environmental Protection Agency, Geological Survey, Environmental, , National Academies of Sciences, Engineering, Medicine, Center for Human Health, Environment, North Carolina State University, NSF, National Sanitation Foundation, EWG, US Food and Drug Administration, FDA, Research, Education, Community Health, National Institute of Environmental Health Sciences Locations: United States, polluters, Raleigh, Texas
Read previewThe Biden administration is cracking down on toxic "forever chemicals" that are widespread in America's tap water, food, and household products. EPA also set limits for mixtures of two or more PFAS chemicals, because research shows they may have combined health impacts. "The technology is there, especially to clean up drinking water, to filter these compounds out of the water. "For too long, many people across the country have had been drinking contaminated water levels that likely impact health." The Biden administration has a broader $9 billion PFAS strategy that goes beyond drinking water, including military bases, airports, and food packaging.
Persons: , Biden, Ken Cook, Michael Regan, Regan, David Andrews, Andrews, it's, Carmen Messer, PFAS Organizations: Service, EPA, Business, Environmental, Companies, Chemours, DuPont, Harvard's, Chan, of Public Health Locations: North Carolina, Minnesota, Fayetteville , North Carolina
While debate rages on about when the Federal Reserve might start cutting interest rates, biotech industry analysts are making the case that the argument for stocks in the sector is growing. Last week, Morgan Stanley analysts noted that it is the months leading up to an initial rate cut when biotech stocks outperform. Morgan Stanley also believes the case for biotech stocks is further reinforced by the financing environment and the outlook for mergers and acquisitions as well as upcoming innovation. The case for innovation Morgan Stanley also favors owning biotech stocks that have a strong drug platform even if the key catalyst of clinical trial data and FDA approvals are farther out. Rhythm ranks among the stocks rated overweight that Morgan Stanley favors in this category.
Persons: Morgan Stanley, Needham, Joseph Stringer, dealmaking, Stringer, erosive, it's, Phathom, GERD, LSEG, Merck, — CNBC's Michael Bloom Organizations: Federal Reserve, Nasdaq, Oncology, Immunology, Phathom Pharmaceutical, Pharmaceuticals, Phathom Pharmaceuticals, LSEG, Drug, Bristol Myers Squibb, Pfizer, Intellia Therapeutics, Rocket Pharmaceuticals Locations: New Jersey
CNN —Using acetaminophen, the active ingredient in Tylenol, during pregnancy was not associated with increased risk of autism, ADHD or intellectual disability in children, a new study found. “This is a very extensive and well-designed study that found no association between acetaminophen use and neurodevelopmental impairment, including autism and ADHD,” he said. For example, the study found that parents who have neurodevelopmental disorders — which have strong heritability — are also more likely to use pain medications, like acetaminophen, during pregnancy. This relationship might make it seem like children who are exposed to acetaminophen during pregnancy are more likely to develop neurodevelopmental disorders, when, in fact, their increased risk is due to genetics, according to the study. The study found significant differences between birthing parents with higher acetaminophen use and those with lower or no use.
Persons: , ” Dr, Eric Brenner, ” Brenner, , Brenner, Dr, Sanjay Gupta, judiciously, Yalda Afshar Organizations: CNN, Karolinska Institute, Drexel University, Duke University, Food and Drug Administration, European Medicines Agency, Get CNN, CNN Health, FDA, David Geffen School of Medicine, UCLA Locations: Sweden
CNN —As the first over-the-counter birth control pill in the United States hits store shelves, the company behind the product, Perrigo, is taking steps to ensure women are aware of this new contraception option. It’s a different formulation than what is in combination hormonal birth control pills, which contain both progestin and estrogen. Combined birth control pills may carry risks for people with uncontrolled hypertension or blood clot risks for smokers older than 35. Most birth control pills are up to 99% effective at preventing pregnancy if taken as instructed. “I’m always a little skeptical of Big Pharma and their partnerships, but I think the general principle of having highly effective over-the-counter birth control be over the counter, that’s empowering” she said.
Persons: “ We’re, Opill, , Colie Edison, “ We’ve, Leila Bahbah, ” Edison, “ we’re, , , , Roe, Wade, prescribers, Joe Biden, Dobbs, Dr, Sanjay Gupta, Colleen Denny, Denny, “ I’m, ” Denny Organizations: CNN, WNBA, , ESPN, US Food and Drug Administration, Jackson, Health Organization, White, Get CNN, CNN Health, NYU Langone Hospital –, Big Pharma Locations: United States, Dobbs v,
But J&J's drug is walking away with a notable edge over its rival. They add more options to a growing arsenal of treatments that have helped improve outcomes for people with multiple myeloma. But the new approvals also give J&J's therapy, which was developed with Legend Biotech, a clear advantage over Bristol Myers's drug. J&J's drug has gradually gained ground over Abecma in the CAR-T market for multiple myeloma, even though it first entered the market a year later. With the new approval on Friday, Jefferies' Shi expects J&J's drug to win the majority of that market share.
Persons: Jonathan Raa, Johnson, Myers's, Bristol Myers, Jefferies, Kelly Shi, Shi, Carvykti, Cantor Fitzgerald, Rick Bienkowski, Kelsey Goodwin, Annika, annikakim.constantino@nbcuni.com Organizations: Nurphoto, Bristol Myers Squibb, Johnson, Food and Drug Administration, FDA, Legend Biotech, Bristol, New York Stock Exchange, NYSE, Reuters, Mount Sinai Hospital, Getty Locations: Bristol, U.S, EU, Japan, Mount Sinai, New York City
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailSome cancer drugs remain unproven 5 years after FDA's accelerated approval, study findsFormer FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss a new study showing some cancer drugs fast racked by the FDA's accelerated approval program remain unproven 5 years after the approvals, news of bird flu spreading in dairy cows, how worried the public should be, and more.
Persons: FDA's, Scott Gottlieb
The study, published Saturday in the New England Journal of Medicine, showed how the drug helped people with Type 2 diabetes who also had one of the most common kind of heart failure, obesity-related heart failure with preserved ejection fraction. Obesity-related heart failure with preserved ejection fraction can severely limit a person’s ability to participate in the activities of daily life. Often, people with type 2 diabetes who have this kind of heart failure have a more severe form than those who don’t have diabetes. People with a more severe form of heart failure sometimes don’t respond as well to medication as those with less severe disease. One death in the Wegovy group and four in the placebo group were related to cardiovascular issues.
Persons: Wegovy, Ozempic, Dr, Mikhail Kosiborod, , ” Kosiborod, Naveed Sattar, ” Sattar, Sanjay Gupta, Kosiborod, Organizations: CNN, New England, of Medicine, Novo Nordisk –, US Food and Drug Administration, FDA, St, University of Glasgow, Science Media, CNN Health, American College of Cardiology Locations: Asia, Europe, North, South America, Kansas City , Missouri, Atlanta
Weight-loss drugs like Ozempic, Wegovy, and Mounjaro are all the rage, and investors are noticing. Since launching in November, the Tema Obesity and Cardiometabolic ETF (HRTS) is up 24%, crushing the S&P 500's 14.8% returns over the same period. Pot and his colleagues at Tema are bullish on the weight-loss drug stocks due to the wave of demand they see coming. Novo Nordisk estimates that only 2% of obesity cases are being treated by weight-loss drugs, Pot said. 4 weight-loss drug stocks to watchPot listed two larger stocks and two smaller ones in the space.
Persons: Maurits Pot, Janus Henderson, Pot, Goldman Sachs, Geoff Meacham, Charles Barkley, Elon Musk, Whoopi Goldberg, Eli Lilly, Lilly Organizations: VanEck Pharmaceutical, Business, World Health Organization, Novo Nordisk, Bank of America, Bank, Nordisk, FDA, Amazon, Therapeutics, Zealand Pharma Locations: Tema, GLP, Danish, it's
Could decaf coffee cause cancer? Experts weigh in
  + stars: | 2024-04-04 | by ( Kristen Rogers | ) edition.cnn.com   time to read: +8 min
Here’s what experts and the FDA say about this clause in the modern context, and what you should know about the safety of decaf coffee. “There is more information on the toxicity of methylene chloride and the levels at which it causes this toxicity,” she added. Then there is the Swiss Water Process, which decaffeinates the beans by soaking them in warm water. The Clean Label Project, an organization that tests consumer products for hidden industrial and environmental contaminants, has detected methylene chloride in several brands of coffee. What you can do nowWhether or not the FDA eventually bans methylene chloride is a decision that could take years.
Persons: Maria, Monique Richard, , Richard, wasn’t, ” Richard, Richard said, Dunkin Organizations: CNN, Food and Drug Administration, Occupational Safety, Health Administration, National Institutes of Health’s, Toxicology Program, Environmental Protection Agency, World Health Organization, Environmental Defense Fund, FDA, US Centers for Disease Control, EPA, Federal Food, Nutrition, maté Locations: California, Tennessee
Are nicotine pouches better than vaping? Zyn, among other brands of nicotine pouches such as Rogue, On! However, FDA officials have allowed the nontobacco nicotine product to stay on the market while the application is under review. Nicotine pouches have varying degrees of nicotine strength; 3 or 6 milligrams per pouch is most common, but some brands have pouches that contain upward of 28 milligrams. What’s more, the Zyn nicotine pouches come in a variety of flavors, including cool mint, wintergreen, coffee and cinnamon, that could be appealing to younger people.
Persons: Philip Morris, Chuck Schumer, , Kecia Christensen, , ’ ”, Christensen, Philip Morris International’s, ” Philip Morris, Meghan Moran, ” Moran, Brian King, Yanfang Ren, ” Ren, Moran Organizations: CNN, Philip Morris International, Facebook, Federal Trade Commission, Food and Drug Administration, American Cancer Society, Nebraska Medicine, FDA, National Cancer Institute, CDC, Centers for Disease Control, ” Philip Morris International, Swedish, Johns Hopkins Bloomberg School of Public Health, Tobacco Survey, FDA’s Center for Tobacco Products, University of Rochester Eastman Institute for Oral Health, Philip Locations: United States, , Baltimore, New York, Mayo
Prenosis' tool, called Sepsis ImmunoScore, uses 22 different parameters like temperature, heart rate and cell counts to help clinicians assess a patient's risk of sepsis, the company told CNBC. While Prenosis is the first company to receive FDA approval for its AI diagnostic tool for sepsis, several organizations have built and released similar solutions. Epic's sepsis model is used in hundreds of hospitals across the U.S., according to a 2021 study published in JAMA Internal Medicine. Even so, Epic reportedly overhauled its sepsis model the following year in an attempt to improve its performance, according to Stat News. Prenosis said it worked to demonstrate the safety and efficacy of Sepsis ImmunoScore to the FDA for around 18 months.
Persons: ImmunoScore, Prenosis Organizations: U.S . Food, Drug Administration, Wednesday, Centers for Disease Control, CNBC, Johns Hopkins University, Nature Medicine, Systems, Stat News, FDA Locations: U.S, White Oak , Maryland, Chicago
In return for private labeling her product for Trader Joe's, she was told she would receive a modest finder's fee based on the co-packer's profits—not a percentage of Trader Joe's sales. After sharing samples with the co-packer and sending a counteroffer asking for greater transparency, she never heard back from him or from Trader Joe's. The small brand owners said that Trader Joe's tactics were unlike Costco or other big chains that do private labeling. Trader Joe's did not immediately respond to a request for comment from Business Insider. AdvertisementI love shopping at Trader Joe's not only because it has good prices on staples, but fun new items to try.
Persons: , Joe's, Joe, Stacy's pita, pita, Tribe, Abraham, packer Organizations: Service, Joe's, Costco, Business Locations: Brooklyn Delhi, California, Zara
CNN —About 1 in every 10 people in the US who uses Adderall or similar combination drugs to treat attention-deficit/hyperactivity disorder (ADHD) has been affected by an ongoing shortage, a new analysis suggests. The US Food and Drug Administration announced that Adderall was in shortage in mid-October 2022, and the share of people with ADHD who filled their prescriptions for Adderall and related medications plunged in the following months. Patients were considered eligible for a monthly prescription fill if they had filled one within the previous two years. Prescriptions for medications used to treat ADHD surged during the Covid-19 pandemic, especially among young adults and women, one study found. But it’s been about a year and a half since she’s been able to fill her Adderall prescription in a “totally uneventful” way, she said.
Persons: Adderall, Robert Califf, Anne Milgram, David Goodman, , Mary Beth King, it’s, she’s, ” King, King, ” Goodman, John Mitchell, ” Mitchell, they’re, ’ ”, , , Dr, Sanjay Gupta, hasn’t Organizations: CNN, US Food and Drug Administration, Drug, of Psychiatry, Behavioral Sciences, Johns Hopkins School of Medicine, American Professional Society, New, Psychiatric Institute, Columbia University Irving Medical Center, Duke University School of Medicine, Get CNN, CNN Health Locations: Sweden
CNN —The US Food and Drug Administration is allowing the use of Rejoyn, the first prescription digital treatment for major depressive disorder. About 18% of American adults – more than 1 in 6 – say they are depressed or receiving treatment for depression, a 2023 Gallup report found. Rejoyn is designed to serve as an adjunct to antidepressants for these partial responders, according to the news release. They were assigned to use either the Rejoyn app or a sham app that gave memory tasks that did not involve cognitive-emotional training or cognitive behavioral therapy. There is also the question of how engaged patients will be with the app, Torous said.
Persons: Rejoyn, Dr, John Kraus, Otsuka, Brian Iacoviello, John Torous, Torous, , ” Otsuka, Sanjay Gupta, , ” Torous Organizations: CNN, Food and Drug Administration, Otsuka Pharmaceutical, Therapeutics, Gallup, Research, Click Therapeutics, Digital Psychiatry, Beth Israel Deaconess Medical, FDA, ” Otsuka Pharmaceutical, CNN Health
Judge-shopping is the practice of strategically filing cases in courthouses where the lawsuits are almost guaranteed to be heard by judges perceived to be sympathetic to the litigants. Texas has other US district courts with single-judge divisions, in addition to Amarillo, where challenges to the Biden administration agenda are frequently funneled through. The Judicial Conference announced after an early March meeting that it was seeking to curb the practice of judge-shopping with the new case assignment policy. The announcement prompted blowback from Republican senators, including Senate Minority Leader Mitch McConnell, who argued that any mandated policy would run afoul of a statute passed by Congress that gives each district court the discretion to design its case assignment protocols. When the Judicial Conference released the formal guidance days later, it indicated that the districtwide assignment policy was recommended, but optional.
Persons: David Godbey, Chuck Schumer, Matthew Kacsmaryk, Donald Trump, Joe Biden’s, Kacsmaryk, Biden, George W, Bush, Schumer, Godbey, , , ” Schumer, Mitch McConnell Organizations: CNN, US, Court, Northern, Northern District of, New, New York Democrat, Amarillo Division, Judicial Conference, Law360, Judicial, Congress Locations: Texas, Northern District, Northern District of Texas, New York, Northern Texas, Amarillo,
He is the author of the “One First” Supreme Court newsletter. Both cases were filed in federal district courts in which the plaintiffs could literally hand-pick the specific federal judge who would be assigned to hear the dispute. Indeed, the Supreme Court granted emergency relief in both the social media and mifepristone cases. But the Supreme Court is another matter. For once, the Supreme Court is the victim of right-wing litigation behavior, not the culprit.
Persons: Steve Vladeck, Stephen I, Biden, they’ve, Terry Doughty, Donald Trump, Matthew Kacsmaryk, Trump, , Neil Gorsuch, Gorsuch Organizations: CNN, University of Texas School of Law, Monroe Division, Court, Western, Western District of, Amarillo Division, Northern, Northern District of, Appeals, Fifth, Fifth Circuit, Democratic, Ninth Circuit, Consumer Financial Protection Bureau, Securities, Exchange, Conference, United, Northern District of Texas, Judicial, Federal, FDA Locations: Murthy v . Missouri, Monroe, Western District, Western District of Louisiana, Amarillo, Northern District, Northern District of Texas, Orleans, Texas, Austin, West Coast, United States
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