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The Food and Drug Administration on Thursday approved Bristol Myers Squibb 's highly anticipated schizophrenia drug Cobenfy, the first novel type of treatment for the debilitating, chronic mental disorder in more than seven decades. Bristol Myers Squibb expects the twice-daily pill, which will be sold under the brand name Cobenfy, to be available in late October, executives told CNBC. Cobenfy could also be a huge long-term sales opportunity for Bristol Myers Squibb, which faces pressure to offset the potential loss of revenue from top-selling treatments that will see their patents expire. But they said the drug will likely have a slow launch, so it may not meaningfully contribute to Bristol Myers Squibb's top line in 2024 and 2025. "We've helped people, we've improved outcomes, we've provided caregivers and physicians with another tool that they can use."
Persons: Bristol Myers, Cobenfy, Guggenheim, doesn't, Andrew Miller, We've, we've Organizations: Drug Administration, Bristol, Bristol Myers Squibb, CNBC, Karuna Therapeutics Locations: U.S
A woman who had life-changing results on a popular weight loss drug struggled to afford it for years. AdvertisementTara Rothenhoefer, a 49-year-old Florida resident, says her life changed when she joined a clinical trial for a promising new weight-loss medication. While regulated, these compounded drugs aren't FDA-approved, raising concerns from doctors about variations in quality. The grey market of weight-loss drugs is vast and complicated. In August, Eli Lilly halved the price of its weight-loss drug Zepbound through single-dose vials — a bid to lure customers back to brand-name drugs, analysts said.
Persons: , Tara Rothenhoefer, Rothenhoefer, Eli Lilly, She's Organizations: Service, Novo Nordisk's, Research, FDA, Pharmaceutical Locations: Florida
CNN —Nearly 200 chemicals connected to breast cancer are used in the making of food packaging and plastic tableware, and dozens of those carcinogens can migrate into the human body, a new study found. Of the recently detected chemicals in food packaging, 40 are already classified as hazardous by regulatory agencies around the world, according to the study. Rates of early-onset breast cancer in women under 50 are increasing, and experts said the trend cannot be explained by genetics alone. A January 2024 update to that list found 921 possibly carcinogenic chemicals, including 642 that may stimulate estrogen or progesterone production, another known risk factor for breast cancer. FCChumon, created by the Food Packaging Forum, is a list of food contact chemicals that have been detected in human breast milk, blood, urine and tissues.
Persons: , Jane Muncke, ” Muncke, Jenny Kay, Len Lichtenfeld, ” Lichtenfeld, Sarah Gallo, ” Gallo, Kay, ” Kay, “ That’s, PFAS Organizations: CNN, Food Packaging, Silent Spring Institute, American Cancer Society, Consumer Brands Association, Food, FDA, Environmental, Toxicology, Contact Chemicals, , National Academies of Sciences, Engineering, Medicine Locations: Zurich, Switzerland
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailDr. Scott Gottlieb on obesity drug costs: Expect to see continued price reductionsFormer FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the price of popular weight-loss drugs, whether steps can be taken to bring drug costs down, and more.
Persons: Scott Gottlieb Organizations: FDA
Whooping cough cases climbing for decadesAs with many infectious diseases, cases of whooping cough dropped to unusually low levels during the pandemic as people limited social interactions and took other precautions to defend against Covid-19. In 2020, the US had about 6,000 cases of pertussis, and that number dropped even further in 2021 to roughly 2,000 cases. Whooping cough starts with symptoms that look a lot like a regular cold: a runny nose, sneezing, a low-grade fever and a tickly cough. That’s led to a hunt for better, more durable immunizations against whooping cough that also don’t cause as many side effects. In some ways, whooping cough is an ideal infection to test in human challenge models.
Persons: , Susan Hariri, Archana Chatterjee, Chatterjee, they’re, it’s, pertussis –, Hariri, Tod Merkel, Merkel, It’s, That’s, Dr, Sanjay Gupta, Melinda Wharton Organizations: CNN, US Centers for Disease Control, CDC’s National Center, Food and Drug Administration, Chicago Medical School, Products Advisory, Covid, FDA’s, Vaccines Research, Regulators, CNN Health, FDA, National Center Locations: United States, Canada
Although originally prescribed to treat type 2 diabetes (Ozempic and Mounjaro), semaglutide and tirzepatide are becoming more and more popular for weight loss. If you are noticing an effect on your mood while using a GLP-1 medication, here’s what might be at play. Antidepressant effectsFor some, using a GLP-1 medication might relieve some anxiety or depression symptoms, Arillotta said. Blood sugarIf you feel like your mood takes a drop while you’re on GLP-1 medications, what and how much you’re eating or drinking might be to blame. “Extremes in blood sugar can impact mood,” said Tara Schmidt, lead dietitian at the Mayo Clinic Diet, an online weight loss program.
Persons: ideation, Thomas Wadden, Davide Arillotta, Arillotta, , Peter Ueda, Amira Guirguis, , Tara Schmidt, ” Schmidt, Guirguis, Giuseppe Floresta, Fabrizio Schifano, ” Guirguis, aren’t, you’ve, Schmidt, “ I’m, Ueda Organizations: Lifeline, CNN, US Food and Drug Administration, Perelman School of Medicine, University of Pennsylvania, FDA, neurosciences, University of Florence, Karolinska Institutet, Diabetes, Swansea University, Mayo Clinic Diet, University of Catania, University of Hertfordshire, American Psychological Association, Locations: Italy, Stockholm, Sweden, GLP, Wales, United Kingdom
download the appSign up to get the inside scoop on today’s biggest stories in markets, tech, and business — delivered daily. Complete with a cold plunge ("excellent for circulation," she said,) hot tub, steam room, and sauna, it looked like something straight out of a luxury hotel. This story is available exclusively to Business Insider subscribers. Now it has an experience shower and a cold plunge and a hot plunge," Mungall told Business Insider. Landry Design Group shared some of the most elaborate health and wellness projects they have worked on with BI.
Persons: , Gwenyth Paltrow, Paltrow, William Mungall, Tom Brady, Mark Wahlberg, Kourtney Kardashian, Mungall, We're, He's Organizations: Service, Architectural, Business, Consulting, Landry Design Group, FDA, BI Locations: LA
7:02 a.m.: JPMorgan hikes Roku price target Roku's focus on monetization for its Platform segment may spell good news for the stock. Analyst Cory Carpenter kept his overweight rating on the stock but upped his price target by $10 to $90. "We believe Lilly's launch of an obstructive sleep apnea (OSA) indication for its GLP-1 medication tirzepatide poses significant patient funnel disruption/distortion risks," the analyst wrote. Analyst Sara Senatore upped its price target by $6 to $118, which implies more than 22% upside from Tuesday's close. "Licensing China would also allow SBUX management to train its focus on the US (73% of 2023 EBITDA before corporate expenses)," the analyst wrote in a Wednesday note.
Persons: Goldman Sachs, Cory Carpenter, Carpenter, Roku, TTD, they've, — Sean Conlon, Wolfe, Resmed Wolfe, Mike, Eli Lilly, Sara Senatore, Senatore, Brian Niccol's, Lizzie Dove, Hilton, Dove, Adrienne Yih, Yih, Fred Imbert Organizations: CNBC, Marriott International, Barclays, Corp, JPMorgan, Google, Amazon, Bank of America, Marriott, Wyndham, Hilton, VF Corp Locations: Starbucks, China, Tuesday's, Timberland, VFC
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFDA's extended approval of breast cancer drug is a 'landmark' for Novartis, CEO saysVas Narasimhan, CEO of Novartis, comments on the progress of the firm's Kisqali metastatic breast cancer drug after the company recently received an extended approval for it from the U.S. Food and Drug Administration.
Persons: Vas Organizations: Novartis, U.S . Food, Drug Administration Locations: U.S
The Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat patients with earlier stages of the disease, drugmaker Novartis said Tuesday. The approval means that tens of thousands of women diagnosed with early-stage breast cancer will have access to a medication that can help prevent their cancer from coming back. The expanded approval is for patients with HR-positive, HER2-negative breast cancer, the most common form of the disease. It comes as rates of breast cancer are increasing in younger women: From 2000 to 2019, rates of breast cancer in women ages 20 to 49 increased by 15.6% according to a study published earlier this year in JAMA Network Open. “You’re always going to be faced with the fact every single day that you have had breast cancer,” she said.
Persons: , Eleonora Teplinsky, it’s, Kisqali, Vandana Abramson, Teplinksy, Nikki Odum, ‘ I’m, ’ ”, Odum, Justin, Denise Yardley, ” Odum, Yardley, Sarah Cannon, Komal, Abramson, ” Teplinsky, that’s, “ You’re, Organizations: Drug Administration, Novartis, Health, European Society for Medical Oncology, Breast Cancer Research, Vanderbilt, Ingram Cancer Center, Kisqali, Sarah, Sarah Cannon Research Institute, Memorial Sloan Kettering Cancer Center Locations: New Jersey, Barcelona, , Nashville , Tennessee, , Smyrna , Tennessee, Nashville, New York
Sleep apnea is a sleep disorder that causes a person's breathing to repeatedly stop and start throughout the night. If it goes untreated, sleep apnea can cause fatigue and lead to more serious health issues like heart problems, hypertension and Type 2 diabetes. Apple's sleep apnea detection feature marks the company's latest attempt to position its wearables as a cheaper, simpler alternative to many existing health-care tests and devices. To get evaluated for sleep apnea, for instance, patients typically participate in an at-home test or an in-lab test where they're monitored overnight. The at-home sleep apnea test from Sleep Doctor costs $189, for example.
Persons: Tim Cook, David Paul Morris, Sumbul Desai Organizations: Apple Inc, Apple, Bloomberg, Getty, . Food, Drug Administration, American Medical Association, Care, Community Health Locations: Cupertino , California, U.S
“The study also shows that food contact materials can contain mutagenic chemicals that harm our DNA, such as heavy metals,” Wagner said. Another chemical group in food packaging that has migrated into people is phthalates, the research revealed. “We’ve got, say, 60 years of research into the migration of chemicals into food from food processing and packaging equipment. “Given that there are (tens) of thousands of food contact chemicals, biomonitoring programs do not have the capacity to test for all chemicals we are potentially exposed to,” Wagner said. “However, there are also important gaps that need to be addressed as we undertake the work to strengthen our food chemical safety activities,” he said.
Persons: , Martin Wagner, Wagner, Jane Muncke, ” Muncke, Muncke, , ” Wagner, “ We’ve, It’s, there’s, Melanie Benesh, you’re, ” Benesh, GRAS, Jim Jones, Benesh Organizations: CNN, Norwegian University of Science, Technology, Food Packaging, Getty, American Chemistry Council, National Institute of Environmental Health Sciences, National Academies of Sciences, Engineering, Medicine, US National Health, Canadian, Korean National Environmental Health Survey, National Health, Environmental, Food and Drug Administration, FDA, US, Committee, Energy Locations: Trondheim, Zurich, Switzerland, phthalates, PFAS, Europe, Biomonitoring California, United States
Over the last year, a growing number of cinnamon products have been recalled in the U.S. due to high levels of lead. That prompted Consumer Reports to test brands such as Badia, McCormick and Morton & Bassett, along with smaller brands, across 17 mainstream and niche grocery stores. It found high levels of lead in 12 products, with levels reaching 3.5 parts per million. Paras cinnamon powder had the most lead, according to Consumer Reports, containing 3.52 ppm. The FDA has wound down some of its response efforts to its cinnamon applesauce investigation but will continue to monitor other products in stores for high lead levels.
Persons: Food and Drug Administration hasn’t, , Laurie Beyranevand, “ I’m, Morton, Bassett, Adam Keating, Keating, ” Beyranevand, there’s Organizations: Consumer, Food and Drug Administration, Center for Agriculture, Food Systems, Vermont Law, Graduate School, FDA, United Nations, Food, Agriculture Organization, Cleveland Clinic, Centers for Disease Control Locations: U.S, McCormick, New York
Ron DeSantis’ administration is once again advising against the mRNA vaccines: this time in the most vulnerable residents. In updated guidance for health care providers released Thursday, the Florida Health Department and state Surgeon General Joseph Ladapo questioned the safety and effectiveness of the mRNA Covid vaccines from Pfizer and Moderna, including for older adults and people with underlying health problems. Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said the Florida surgeon general's guidance is unnecessarily alarming people about the Covid vaccines. "The mRNA vaccines are remarkably safe," he added. The CDC currently recommends everyone ages 6 months and older get an updated Covid vaccine this fall from any of the three options.
Persons: Ron DeSantis ’, Joseph Ladapo, Nature Cardiovascular Research ​, Paul Offit, Offit, They’re, Isaac Bogoch, , Boguch, Ladapo Organizations: Florida Health Department, Pfizer, Moderna, Nature Cardiovascular Research, Children’s Hospital of Philadelphia, Food and Drug Administration, United States, University of Toronto, CDC, Emergency Locations: Florida, U.S
Read previewLottie Moss, 26, is speaking out about the dangers of taking Ozempic. During an episode of her "Dream On" podcast, the model — who is Kate Moss' half-sister — said she ended up in a hospital after taking the drug. Moss said she went to the hospital after a particularly bad day when she couldn't keep any liquids or food down. Reflecting on her use of Ozempic, Moss called it "the worst decision I ever made." AdvertisementLast year in Austria, several people were brought to the hospital with life-threatening seizures after taking counterfeit versions of the drug.
Persons: , Lottie Moss, Kate Moss, I'm, Moss, didn't, Eric Kastango, Ozempic, semaglutide Organizations: Service, Business, Novo Nordisk, FDA, Austrian Federal Office, Safety, Health Care Locations: Austria
Taking a high dose of ADHD drugs is linked to more than five times greater risk of developing psychosis or mania, according to a new study published Thursday in the American Journal of Psychiatry. The research is among the first to find a relationship between escalating doses of the drugs — amphetamines, in particular — and a greater likelihood of psychotic symptoms. The drugs include Adderall, Vyvanse and generic amphetamines, such as dextroamphetamine. The medium dosage — 20 mg to 40 mg of Adderall, 50 mg to 100 mg of Vyvanse or 15 mg to 30 mg of dextroamphetamine — was linked to a 3.5 times higher risk. There was no increased risk of psychosis with another ADHD drug, Ritalin, which isn’t an amphetamine.
Persons: it’s, , Jacob Ballon, hadn’t, Will Cronenwett, ” Cronenwett, Vyvanse, Takeda, Lauren Moran, Brigham, , ” Moran, Moran, Cronenwett, ” Ballon, they’re Organizations: American, of Psychiatry, Stanford Medicine, Northwestern Medicine, Psychiatry, NBC News, Takeda Pharmaceuticals, . Food, Drug Administration, FDA, Pharmaceuticals, McLean Hospital, Mass Locations: United States, U.S, Boston
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailModerna CEO: Plans to file Covid and flu combo shot with FDA by the end of the yearStephane Bancel, Moderna CEO, joins 'Squawk Box' to discuss Moderna's recent stock performance, what could explain the stock's underperformance, and much more.
Persons: Stephane Bancel Organizations: Email Moderna, FDA, Moderna
The next highest level was found in cinnamon powder from EGN (2.91 ppm), followed by Mimi’s Products ground cinnamon (2.03 ppm), ShopRite Bowl & Basket ground cinnamon (1.82 ppm), Rani Brand ground cinnamon (1.39 ppm), Zara Foods cinnamon powder (1.27 ppm), Three Rivers cinnamon stick powder (1.26 ppm), Yu Yee Brand five spice powder (1.25 ppm), BaiLiFeng five spice powder (1.15 ppm), Spicy King five spices powder (1.05 ppm), Badia cinnamon powder (1.03 ppm) and Deep cinnamon powder (1.02 ppm). told CNN via email that the company’s ground cinnamon products comply with all federal and international law. These include ground cinnamon and organic ground cinnamon sold by 365 Whole Foods Market, which contained 0.12 ppm and 0.02 ppm of lead, respectively. Morton & Bassett San Francisco 100% organic ground cinnamon, Loisa organic cinnamon and Sadaf cinnamon powder tested at 0.04 ppm of lead. The latest, published in August, listed 10 different cinnamon products with levels as high as 3.93 ppm of lead.
Persons: Paras, Rani, Yu Yee, EGN, Mimi’s, Nuria Lambert, Karen O’Shea, Alina Lasta, ” Guitar, Bassett, James Rogers, ” Rogers, Rogers, , Dr.Pieter Cohen, Cohen, we’re, ” Cohen, Courtney Rhodes, Rhodes Organizations: CNN, Consumer Reports, Mimi’s, ShopRite, Consumer, Mimi’s Products, Wakefern Food Corp, Badia Spices, FDA, American Spice Trade Association, World Health Organization, Food and Agriculture Organization, United, New York State Department of Health, US Environmental Protection Agency, WHO, Morton, Bassett San, WanaBana, Weis, Food and Drug Administration, Cambridge Health Alliance, Biden, Food Locations: Zara, Badia, United Nations, New York, Connecticut , New Jersey, Bassett San Francisco, Ecuador, Schnucks, Somerville , Massachusetts
Apple announced on Monday that its AirPods Pro 2 headphones will become an FDA-cleared hearing aid in the coming weeks through a software update. Apple CEO Tim Cook has highlighted health features as the company's "most important contribution to mankind." The new feature is a free software update for some AirPods models and will be included with Apple's $249 AirPods Pro 2. Many over-the-counter hearing aids are much more expensive, according to buyers guides cited by the Hearing Loss Association of America, an advocacy group. Analysts say that adding health features like a hearing aid expands the market for the device, which could help sales.
Persons: Sumbul Desai, Tim Cook, Barbara Kelley, Apple, Gene Munster Organizations: AirPods, Apple, FDA, Food and Drug Administration, RBC Capital Markets, of America, Analysts, Asset Management
Digital health company Noom on Thursday announced it will offer a compounded GLP-1 drug as part of a new weight loss product that starts at $149. Noom has offered weight loss programs for years, and consumers can already try to access those branded medications through its platform. Compounded GLP-1 medications are typically much cheaper than their branded counterparts. Most insurance plans cover GLP-1s when they are used to treat diabetes, but coverage of the weight loss drugs is less widespread. Consumers can get started with the Noom GLP-1 RX program by filling out an intake form on the website.
Persons: Wegovy, Noom, Geoff Cook, Cook, Dr, Adonis Saremi, They'll Organizations: CNBC, U.S . Food, Drug Administration, FDA Locations: U.S, United States
Kourtney Kardashian just launched an herbal supplement called GLP-1 Daily. GLP-1 drugs like Ozempic and Wegovy are FDA-approved for diabetes and weight-loss. Go to newsletter preferences Thanks for signing up! AdvertisementKourtney Kardashian Barker's supplement brand, Lemme, is the latest to jump on the Ozempic craze. Their new daily supplement, Lemme GLP-1 Daily, is marketed as a weight management tool.
Persons: Kourtney Kardashian, , Lemme Organizations: FDA, Service, Business
Gilead 's twice-yearly shot reduced HIV infections by 96% in a second large study, the company said Thursday. The positive phase three trial data on lenacapavir sets the stage for likely approval by the U.S. Food and Drug Administration for HIV prevention. The company said 99.9% of participants who received lenacapavir did not acquire HIV, with two cases among 2,180 people. Gilead in June also said lenacapavir was 100% effective at preventing HIV in another late-stage trial with cisgender women. The trial results should lead to an FDA approval and launch in the market by 2025, Yee said.
Persons: Gilead, Daniel O'Day, lenacapavir, Michael Yee, Yee Organizations: U.S . Food, Drug Administration, PrEP, Centers for Disease Control, Jefferies, CNBC, YouTube Locations: Gilead
Novo Nordisk's American rival, Eli Lilly, has also been testing obesity-beating drugs for children as young as six. Wegovy and similar drugs for weight loss have become a huge business. The drugs' success has made Novo Nordisk the most valuable company in Europe. AdvertisementChildhood obesityAn FDA approval on weight loss drugs for children could open up a new market for Novo Nordisk. In June, US Sen. Bernie Sanders announced that Novo Nordisk CEO Lars Jørgensen would testify before the committee on September 24 at a hearing focusing on the prices that Novo Nordisk charges Americans for their drugs, Ozempic and Wegovy.
Persons: , Saxenda, Novo, Claudia Fox, Eli Lilly, Goldman Sachs, Wegovy, Sen, Bernie Sanders, Lars Jørgensen, Sanders Organizations: Service, BMI, Business, FDA, Financial Times, Novo Nordisk, Centers for Disease Locations: Madrid, Europe
Last month, the American Red Cross declared an emergency blood shortage after its national supply fell by more than 25% in July. Shortages can be dire for patients since doctors have to make tough decisions about who needs blood transfusions the most. McConnell is CEO of a four-year-old startup called Safi Biotherapeutics, which is working to manufacture inexpensive red blood cells at scale. Scientists have already discovered how to grow red blood cells from stem cells, but it's a costly and complex process that typically yields small amounts at a time. Safi's goal is to build on these advancements and produce large quantities of blood that could eventually be used commercially to help care for patients and avoid blood shortages.
Persons: Doug McConnell, McConnell, Safi Organizations: Red Cross, Cross, U.S, Safi, CNBC, U.S . Department of Defense, J2 Ventures, U.S . Food, Drug Administration, FDA Locations: U.S
The Food and Drug Administration announced Tuesday that it has begun a research project examining the possible effects of toxic metals in tampons and that it is launching an independent review. A study published in July found a variety of metals, including arsenic, mercury and lead, in more than a dozen brands of tampons. While the study detected metals, it couldn’t conclude whether their existence led to any harm in the women. “Women use about 7,400 tampons over the course of their reproductive years, so the presence of potentially harmful metals and chemicals in these products is incredibly concerning,” caucus members wrote. “These initiatives will enable the FDA to complete a risk assessment of metals contained in tampons, based on a worst-case scenario of metal exposure,” the agency wrote.
Persons: Kathrin Schilling, Organizations: Drug Administration, Columbia University Mailman School of Public Health, UC Berkeley School of Public Health, Democratic Women’s Caucus, FDA Locations: tampons, U.S
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