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When my daughter was 3 months old we found out she had significant hearing loss in one ear. We chose not to go through with a cochlear implant because there were no guarantees. Our world shifted when we received the diagnosis that our 3-month-old daughter had significant hearing loss in her right ear. Related storiesThere was no guarantee that the cochlear implant would restore our daughter's hearing to normal levels. AdvertisementOther individuals who received cochlear implants as children reported hearing loss in their better ear following the surgery.
Persons: , Chase Organizations: Service, Food and Drug
Now, a new study, building upon previous evidence, has found that among teens, vaping often may spike the risk of exposure to lead and uranium — potentially harming brain and organ development in young people. However, chronic exposure to metals, “even at low levels, can lead to detrimental health impacts, affecting cardiovascular, renal, cognitive and psychiatric functions,” she added. The study was conducted at one point in time, so the authors couldn’t control for chronic or long-term exposure. The authors acknowledged that their study is observational, meaning it didn’t find a causal relationship between vaping and toxic metal levels. But knowing why this preference led to higher uranium exposure requires more research.
Persons: CNN — Vaping, vaping, , Hongying Daisy Dai, Vaping, Dai, coauthors, vaped, Dai wasn’t, ” Dai, , Lion Shahab, Shahab, wasn’t, don’t, ” Shahab Organizations: CNN, Tobacco, Tobacco Survey, US Food and Drug Administration, biostatistics, University of Nebraska Medical Center, National Youth Tobacco Survey, Tobacco and Health, University College London, UCL Tobacco, Alcohol Research, Locations: United States, vaping
Tirzepatide is the active ingredient in both Eli Lilly's diabetes treatment Mounjaro and its anti-obesity drug Zepbound. Based on that calculation, earnings will be lower by about 13 cents per share, he said, in research published last Tuesday. "Strong demand for Mounjaro & Zepbound can easily pull through in 2H24 and make up for any 1H24 shortfalls." For the week ended April 19, combined prescriptions of Mounjaro and Zepbound rose 63% year over year, according to IQVIA. Wells Fargo Mohit Bansal said he expects investors to look past any Trulicity shortfalls as the focus is firmily on Zepbound and Mounjaro for Lilly's future growth.
Persons: Eli Lilly, Eli, James Shin, Lilly, Shin, David Risinger, Zepbound, Wells, Bansal, Jo Walton, Walton, Lilly's, Tirzepatide, Deutsche Bank's Shin, — CNBC's Michael Bloom Organizations: Drug Administration, Deutsche Bank, IMS, UBS, Research, Deutsche, FDA Locations: 2H24, U.S
The fusion of human ingenuity and machine intelligence is offering an innovative approach to personalized mental-health care. They can also use AI to assess the quality of their services and find ways to improve as providers of mental-health care. As technology becomes more involved in mental-health care, ensuring data security, confidentiality, and equitable access to services must be top priorities. How an AI platform is helping mental-health-care providers improve their servicesThe AI platform Lyssn is another tech-driven tool for mental-health services. Lyssn aims to hold providers accountable for improved care, especially because "the quality of mental-health care is highly variable," Imel said.
Persons: , Christopher Romig, Stella, Shaheen Lakhan, Daniel Rimm, Haig Goenjian, Zac Imel, Michael Tanana, Imel, Darin Carver, Carver, It's Organizations: Service, Therapeutics, Click Therapeutics, Food and Drug Administration, Weber Human Services Locations: Tanana
It's the busiest week of the earnings season, and it could have major consequences for the stock market. This quarter: The fast-food giant is expected to report single-digit earnings and revenue growth from the year-earlier period, LSEG shows. Amazon is set to report earnings after the close. What history shows: Pfizer earnings beat earnings expectations 87% of the time, per Bespoke. Thursday Apple is set to report earnings after the bell.
Persons: Jeffrey Bernstein, Bernstein, JPMorgan's Andrea Teixeira, Teixeira, AMZN, Joseph Feldman, Feldman, AAPL, , Apple Organizations: Apple, Pfizer, IBM, CNBC, Barclays, Investment, Management, AWS, Amazon, pharma, Food and Drug Administration, UBS Locations: China
It's a week jam-packed with notable events, including earnings from Apple , Amazon and Eli Lilly . He also said to pay attention to Wednesday's Federal Reserve meeting and Friday's employment figures from the Department of Labor. "We have to run such a ridiculous gauntlet next week that I have no idea how it'll play out," he said. Wednesday also brings reports from Wingstop , Carvana and Marriott . Apple will report on Thursday, and Cramer noted there's been a lot of negative sentiment from investors surrounding the company.
Persons: CNBC's Jim Cramer, Eli Lilly, Jensen Huang, Cramer, it's, he'll, Seagen, there's Organizations: Apple, Federal Reserve, Department of Labor, Nvidia, Food and Drug Administration, Starbucks, CVS, Pfizer, Amazon, Walgreens, Marriott, Vision Locations: It's, China, Wingstop, Carvana
Federal regulators on Friday said that they had not yet discovered live bird flu virus in the first batch of retail milk samples they tested, a reassuring indication that the milk on store shelves remains safe despite an outbreak of the virus among diary cows. In an online update, the Food and Drug Administration said an initial set of tests looking for live virus, not just genetic fragments, suggested that the pasteurization process was effectively neutralizing the pathogen. “These results reaffirm our assessment that the commercial milk supply is safe,” the F.D.A. wrote in the update, adding that the testing efforts were ongoing. Officials also tested infant and toddler formula, which incorporate powdered dairy, and did not find the virus, the agency wrote.
Organizations: Food and Drug Administration, Officials
The Food and Drug Administration on Friday approved Pfizer 's treatment for a rare genetic bleeding disorder, making it the company's first-ever gene therapy to win clearance in the U.S. The agency greenlit the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B who meet certain requirements. Without that protein, called factor IX, patients with hemophilia B bruise easily and bleed more frequently and for longer periods of time. The gene therapy will compete with Australia-based CSL Behring's Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. The company is also developing a gene therapy for Duchenne muscular dystrophy, a genetic disorder that causes muscles to weaken gradually.
Persons: IX, hemophilia, Adam Cuker, Cuker Organizations: Drug Administration, Pfizer, U.S, Penn's, Spark Therapeutics, hemophilia Locations: U.S, Australia
Federal regulators have discovered fragments of bird flu virus in roughly 20 percent of retail milk samples tested in a nationally representative study, the Food and Drug Administration said in an online update on Thursday. Samples from parts of the country that are known to have dairy herds infected with the virus were more likely to test positive, the agency said. Regulators said that there is no evidence that this milk poses a danger to consumers or that live virus is present in the milk on store shelves, an assessment public health experts have agreed with. But finding traces of the virus in such a high share of samples from around the country is the strongest signal yet that the bird flu outbreak in dairy cows is more extensive than the official tally of 33 infected herds across eight states. “It suggests that there is a whole lot of this virus out there,” said Richard Webby, a virologist and influenza expert at St. Jude Children’s Research Hospital.
Persons: , Richard Webby, Jude Children’s Organizations: Food and Drug Administration, Regulators, St, Jude Children’s Research
Sleep supplements: Can they help me sleep?
  + stars: | 2024-04-25 | by ( Katia Hetter | ) edition.cnn.com   time to read: +8 min
Some 18% of American adults take a form of medication to help them sleep, including over-the-counter pills and prescription medications, according to a 2023 US Centers for Disease Control and Prevention report. Some 6.3% said that they take sleep medications every day and 2.1% took medication most days. While medical treatments can help with sleep, are some forms more effective than others? Melatonin supplements are lab-made versions of this hormone. There is some evidence that melatonin supplements can help with jet lag.
Persons: CNN —, Leana Wen, Wen, There’s Organizations: CNN, for Disease Control, George Washington University, Food and Drug Administration, FDA
In recent months the highly pathogenic H5N1 virus has been spreading through US cattle herds for the first time ever. The cow-to-cow transmission is the latest escalation in a global outbreak that began when the virus reemerged in Europe in 2020. Bill Powers with his flock of white turkeys, kept under shelter to prevent exposure to bird flu, in Townsend, Delaware. Nathan Howard/Getty ImagesDr. Jerome Adams, a former surgeon general and the director of health equity at Purdue University, is getting deja vu. AdvertisementOnly testing the sickSo far, the USDA has only been testing cattle herds when an animal appears sick.
Persons: , Jeremy Farrar, Nathan Frandino, Farrar, Bill Powers, Nathan Howard, Jerome Adams, they've, Adams, Donald Trump, hasn't, Terry Chea, they're, Zeynep Tufekci, Jean Carroll, Alexi J . Rosenfeld, President Trump, Trump, Biden Organizations: Service, Business, World Health Organization, Washington Post, Food and Drug Administration, New York Times, FDA, Johann, Reuters, US Centers for Disease Control, Purdue University, CDC, US Department of Agriculture, White, USDA Locations: Europe, South America, Fresno , California, Texas, Townsend , Delaware, COVID, Sonoma County , California
So far, though, many public health experts don't think this rings alarm bells about the safety of the food supply. Nathan Frandino/ReutersThe FDA oversees the nation's milk supply, and the US Department of Agriculture oversees dairy cows. Both say they believe the commercial milk supply is safe, due to the pasteurization process and the practice of disposing of milk from sick cows. Some states allow the sale of unpasteurized, aka "raw," milk or cheese, which the CDC recommends avoiding. "To date, we have seen nothing that would change our assessment that the commercial milk supply is safe.
Persons: , Dr, Jerome Adams, Trump, Pasteurization, Nathan Frandino, Carlos Barria, Adams, Samuel Alcaine, Cook, who's, I'm Organizations: Service, Drug Administration, Business, Purdue University, Johann, FDA, US Department of Agriculture, Washington Post, The New York Times, Mountain Creamery, Cornell University, CDC, Workers Locations: Fresno , California, Middletown , Maryland
But some eligible beneficiaries could still face out-of-pocket costs for the highly popular and expensive drug, KFF said. Certain Medicare prescription drug plans may also wait until 2025 to cover Wegovy. Medicare's budget could be strained as more plans cover the costs of Wegovy. Among the Medicare beneficiaries who are obese or overweight and have a history of heart disease, 1.9 million also have diabetes, according to KFF. That makes them already eligible for Medicare coverage of other GLP-1 drugs approved for that condition.
Persons: KFF Organizations: Novo Nordisk, Medicare, Drug Administration, Novo Locations: London, Britain, U.S
The insects will infiltrate a much bigger geographical area than similar occurrences in most years because they’re part of the dual emergence of two particular periodical cicada broods. Although the full-scale emergence isn’t underway yet, experts have some guidance on how to prepare for cicada season. A periodical cicada that has just shed its outer skeleton crawls among holes dug by emerging cicada nymphs on May 20, 2021, in Takoma Park, Maryland. A young tree in Takoma Park, Maryland, is draped in netting in May 2021 to protect its small branches from being damaged by periodical cicadas laying their eggs in them. It’s not clear why periodical cicadas evolved to emerge every 13 or 17 years.
Persons: Louis —, Chip Somodevilla, , , Paula Shrewsbury, ” Shrewsbury, John Lill, sapling, Lill, Jason Whitman, Shrewsbury, They’re Organizations: CNN, Naturalists, Southern, University of Maryland, North, George Washington University, US Food and Drug Administration Locations: Chicago, Nashville, St, Northern Illinois, Takoma Park , Maryland, North America, United States
The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older. It is the first time in two decades that the F.D.A. has approved a new antibiotic for U.T.I.s, which annually affect 30 million Americans. is committed to fostering new antibiotic availability when they prove to be safe and effective.”
Persons: U.T.I.s, Dr, Peter Kim Organizations: Drug Administration, Drug, Research Locations: Europe, U.S
CNN —For the fourth time since she became the federal government’s top Supreme Court advocate, Solicitor General Elizabeth Prelogar is arguing an abortion-related case. When Prelogar argues before the Supreme Court, she is arguing in front of several alumni of the US Office of the Solicitor General. She also clerked for her current boss, Attorney General Merrick Garland, when he was a DC Circuit judge, before her Supreme Court clerkships. She went on to litigate Supreme Court cases for private firms and worked on special counsel Robert Mueller’s investigation. Likewise, the abortion case Prelogar argued last month could have significant consequences for federal power.
Persons: Elizabeth Prelogar, Prelogar, Department’s, Biden, , Stephanie Toti, she’s, Ruth Bader Ginsburg, Elena Kagan, Kagan, Obama, John Roberts, George H.W, Samuel Alito, Neil Gorsuch, Brett Kavanaugh, Roe, ” Prelogar, General Merrick Garland, Robert Mueller’s, Beth Brinkmann, Clinton, Brinkmann, Prelogar’s, Court’s Roe, Wade, , Roberts, Gorsuch, Amy Coney Barrett, ” Toti, “ That’s Organizations: CNN, Miss Idaho, NPR, Emory University, Harvard Law School, DC Circuit, litigate, The Justice Department, Idaho, Labor, Center for Reproductive Rights, Food and Drug Administration, Justice Department, Republican Locations: Bush, Texas, ” An Idaho, Idaho
The court’s far-right wing, perhaps in an attempt to keep those two justices on their side, framed the case as a federal overreach into state power. Turner, Idaho’s attorney, shot back that mental health could essentially open a loophole. Conservatives have long opposed allowing exceptions to strict abortion bans for mental health. Justice Samuel Alito, a fellow conservative, picked up on that same theme, repeatedly pressing Prelogar to explain whether the Justice Department views mental health as a way around Idaho’s abortion ban. That is exactly the kind of political influence that the Supreme Court, especially under Roberts, has generally tried to avoid.
Persons: Biden, Elizabeth Prelogar, Roe, Wade, Brett Kavanaugh, John Roberts, Amy Coney Barrett, Prelogar, ” Prelogar, , Roberts, Barrett –, Barrett, teed, Joshua Turner, Sonia Sotomayor, Turner, Elena Kagan, , Alito, CNN Sotomayor, , Clarence Thomas, EMTALA, Neil Gorsuch, , Samuel Alito, ” Alito, , Joe Biden, Donald Trump, Trump, – Gorsuch, Kavanaugh Organizations: CNN, Justice, Labor, Liberal, Republican, Supreme, Department, Wade, Idaho, energizing Democratic, Food and Drug Administration, GOP Locations: Idaho, Wisconsin
Federal regulators on Tuesday said that samples of pasteurized milk from around the country had tested positive for inactive remnants of the bird flu virus that has been infecting dairy cows. The viral fragments do not pose a threat to consumers, officials said. “To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the Food and Drug Administration said in a statement. Over the last month, a bird flu virus known as H5N1 has been detected in more than 30 dairy herds in eight states. The virus is also known to have infected one farmworker, whose only symptom was pink eye.
Persons: Organizations: and Drug Administration, Agriculture Department
The new Florida law has limited exemptions for rape, incest and to protect the life of the mother. In the electionPresident Joe Biden visited Florida to focus on abortion rights Tuesday. Referendums placing the issue of abortion rights before voters will be on the ballot in Arizona and Florida. New realityIt is the cases currently before the Supreme Court that could have the most direct effect on the new reality for pregnant American women. Cox fled Texas to obtain an abortion just before the state Supreme Court denied her access to the care under the medical exemption in Texas’ abortion law.
Persons: Roe, Wade, Joe Biden, Kamala Harris, CNN’s Edward, Isaac Dovere, Donald Trump, Wade . Biden, Harris, Trump, CNN’s Tierney Sneed, , Read, Jen Adkins, Adkins, CNN’s Meg Tirrell, John Bonifield, Julie Lyons, who’s, ” Lyons, Allie Phillips, Dobbs, Amanda Zurawski, Trump’s, Jill Biden, Kate Cox, Cox, CNN’s Priscilla Alvarez, Michael Williams, Dale Mabry, Biden, Joe Raedle, Dovere, he’s, , Court’s Dobbs Organizations: CNN —, Senate, Biden, CNN, Jackson, Health, Hillsborough Community, Republican, Locations: Florida, Arizona, Florida ., Idaho, Sneed, Portland , Oregon, Hailey, Sun Valley, New York, Tennessee, Texas, Florida , Arizona, year’s State, Tampa , Florida
Ultragenyx Pharmaceutical has several growth opportunities ahead that could lead its share price to boom over the next year, according to RBC Capital Markets. Analyst Luca Issi initiated research coverage of the pharmaceutical company, which develops treatments for rare and ultra-rare diseases, with an outperform rating and $77 price target. Ultragenyx is forecasting between $500 million and $530 million in revenue for 2024, driven by rare bone disease drug Crysvita, long-chain fatty acid oxidation disorder drug Dojolvi, as well as therapies Mepsevii and Evkeeza. The analyst is also looking ahead to Ultragenyx's treatments for Angelman syndrome, Glycogen storage disease type 1, or GSD1a, plus Wilson's disease as potential opportunities to drive up the stock. Wilson's disease is a rare genetic disorder that prevents the body from eliminating copper, which then leads it to accumulate in the liver, brain and other organs.
Persons: Luca Issi, Issi, Issi's, Issa, GSD1a Organizations: Ultragenyx Pharmaceutical, RBC Capital Markets, U.S . Food, Drug Administration
CNN —Zepbound, a popular weight loss drug, also seems to help people with obstructive sleep apnea, drugmaker Eli Lilly said Wednesday. Based on results from trials in people with sleep apnea, the company said it plans to submit the material to the US Food and Drug Administration to potentially expand the use of Zepbound for obstructive sleep apnea. Obstructive sleep apnea is a disorder that causes people to briefly stop breathing while they are sleeping, sometimes several times an hour. While people are more at risk for obstructive sleep apnea as they get older, it often develops when people gain weight and have overweight or obesity. Some doctors have been prescribing the weekly injection off label to people with obstructive sleep apnea, and Lilly has been testing the drug for obstructive sleep apnea since June 2022.
Persons: CNN —, Eli Lilly, Lilly, didn’t, Dr, Sanjay Gupta, CNN’s Meg Tirrell, Amanda Sealy Organizations: CNN, Food and Drug Administration, World Health, US Food and Drug Administration, CNN Health, American Diabetes Association
An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023. Eli Lilly on Wednesday said its highly popular weight loss drug Zepbound showed the potential to treat patients with the most common sleep-related breathing disorder in two late-stage clinical trials. Zepbound was more effective than a placebo at reducing the severity of obstructive sleep apnea, or OSA, in patients with obesity after a year, according to preliminary data from both trials. Eli Lilly previously announced that the FDA granted Zepbound "fast track designation" for patients with moderate-to-severe OSA and obesity. Zepbound has slipped into shortages since receiving approval in the U.S. for weight management in November.
Persons: Eli Lilly’s, Eli Lilly, Zepbound, Dr, Jeff Emmick, Eli Lilly's Organizations: U.S . Food, Drug Administration, FDA, OSA Locations: New York City, U.S
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
GLP-1 drugs were originally developed to treat type 2 diabetes. Drugmakers are discovering the injections may also aid weight loss, heart issues, and sleep apnea. AdvertisementAnother new indication for injectable GLP-1 drugs: better sleep. On Wednesday, drugmaker Eli Lilly announced positive results from a large, phase-3 clinical trial, testing Zepbound (the drug name for tirzepatide) as a treatment for sleep apnea. Related storyAlready, GLP-1 drugs have been indicated for the treatment of:ObesityHeart diseaseAdvertisementIn clinical trials, GLP-1 drugs have also shown some promise for treating other conditions, including:Non-alcoholic fatty liver diseaseAddictionDepressionParkinson's and Alzheimer'sCancerThese breakthroughs may be tied to the gut-brain connectionScientists think that the main reason GLP-1 drugs work well is because of their effect on our body's gut-brain connection.
Persons: , drugmaker Eli Lilly, Eli Lilly, KATERYNA, Daniel Drucker, GLP, Eric Topol Organizations: Service, Food and Drug Administration, American Diabetes Association, University of Toronto
Nuvalent could be a winning biotech in the world of cancer treatments, according to Jefferies. Analyst Roger Song initiated the clinical-stage biopharmaceutical company with a buy rating and $97 price target, which implies 49.8% potential upside for shares over the next 12 months. "NUVL leverages strong expertise in structure-based chemistry and deep understanding of unmet [patient] needs to develop potentially 'best-in-class' small molecule targeted cancer therapy," Song wrote in a Wednesday note. "We think both candidates poise well in later line and have strong potential to move into frontline treatments." The company posted a fourth-quarter loss that was slightly wider than expected, at 62 cents per share.
Persons: Roger Song, Jefferies Organizations: Jefferies, U.S . Food, Drug Administration, FactSet Locations: U.S
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