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Sarepta gave the one-time drug a price tag of $3.2 million, making it the second most-expensive medicine in the world. DMD affects one in 3,500 to 5,000 newborns, mostly boys because of the way it’s inherited, according to Johns Hopkins Medicine. The primary goal of the confirmatory trial was improvement on a measure known as the North Star Ambulatory Assessment, a scale of how well kids can stand, walk and perform other movements. The difference wasn’t statistically significant, meaning technically the study failed to meet its main goal. The company said no new safety issues emerged in the trial, which it called EMBARK.
Persons: Doug Ingram, ” Ingram, Sarepta, , Dr, Sanjay Gupta, Ingram, Organizations: CNN, US Food and Drug Administration, Sarepta Therapeutics, FDA, Johns Hopkins Medicine, North Star, CNN Health
CNN —Britain’s health agency is warning the public not to buy pre-filled pens claiming to contain the weight loss drugs Ozempic and Saxenda without a prescription, after a small number of people were hospitalized. Ozempic is used to treat adults with type 2 diabetes, and is used off-label for weight loss. More than 350 potentially fake Ozempic pens have been seized since January of this year, according to the MHRA. The agency has also received reports that patients have obtained fake Saxenda pens in the UK through “through non-legitimate routes.”No fake weight-loss pens were seized before January 2023, the agency says. The maker of both drugs, Novo Nordisk, told CNN Thursday that it is aware that counterfeit pens are being circulated.
Persons: Ozempic, ” Allison Schneider, Dr, Sanjay Gupta, Alison Cave, ” Ozempic, , Meg Tirrell Organizations: CNN, Medicines, Healthcare, Agency, Novo Nordisk, , “ Novo Nordisk, General Pharmaceutical Council, Get CNN, CNN Health, European Medicines Agency, European Union Locations: Ozempic, “ Novo, Novo, Germany, Europe
There’s no evidence fake Ozempic pens have been dispensed to patients from legal pharmacies and no indication any patients have been harmed, the EMA said in a statement. The fake pens were caught because they were packaged with real serial numbers that were flagged as inactive when the packs were scanned. “Check the patient information leaflet for Ozempic to see what the genuine Ozempic pens should look like,” the EMA said in its warning for patients. The fake pens were detected as Ozempic and similar medicines used for both diabetes and weight loss are in shortage in both the US and Europe. Both Novo Nordisk and Eli Lilly have filed lawsuits against medical spas, wellness centers and compounding pharmacies to stop them from selling what they call “unlawful” copycats.
Persons: , Dr, Sanjay Gupta, , Eli Lilly, it’s Organizations: CNN, European Union, European Medicines Agency, EMA, CNN Health, Novo Nordisk, , Nordisk Locations: United Kingdom, Germany, Europe
London CNN —Novo Nordisk has dethroned Bernard Arnault’s luxury goods giant LVMH as Europe’s most valuable company. At the close of trading Monday, Novo Nordisk (NVO) had a market capitalization of 2.96 trillion Danish krone ($428 billion). “We are just scratching the surface,” Novo Nordisk CEO Lars Fruergaard Jørgensen told CNN’s Meg Tirrell in a recent interview. Novo Nordisk has raked in almost 49 billion Danish krone ($7 billion) in profit over the first six months of this year, up 30% from the same period in 2022. Booming sales of its drugs have led to an influx of US dollars into Denmark’s economy, pushing up the value of the Danish krone.
Persons: Bernard, Wegovy, Louis Vuitton, Hennessy, , , Steve Barclay, Carsten Snejbjerg, Lars Fruergaard Jørgensen, CNN’s Meg Tirrell, , Organizations: London CNN — Novo Nordisk, Novo Nordisk, Louis, Health Service, Health, Social Care, Nordisk, Nordisk's, Bloomberg, Getty, World Health Organization, Danish krone, European Central Bank, Novo, UBS, Wegovy Locations: Danish, Ozempic, Wegovy, United States, Copenhagen, Denmark, Denmark’s, Novo Nordisk’s
There are 64 million people globally living with heart failure, Novo Nordisk said in a statement about the trial results. This type of heart failure accounts for more than half of all cases in the US and is increasing in prevalence, according to Kosiborod and his co-authors. He noted that 80% of patients with this kind of heart failure in the US have obesity or are characterized as overweight. Until recently, the main treatment options for people with this kind of heart failure were diuretics, sometimes called water pills, Kosiborod said. They’re also changing the way researchers think about obesity, and the results in heart failure contribute to that paradigm shift, Kosiborod said.
Persons: Mikhail Kosiborod, ” Kosiborod, Kosiborod, semaglutide, , , Eli Lilly, Dr, Sanjay Gupta, They’re, “ It’s Organizations: CNN, drugmaker Novo Nordisk, New England, of Medicine, Saint, Kansas, European Society of Cardiology, Novo Nordisk, CNN Health Locations: Kansas, Kansas City, Amsterdam
“And since the masks that are most effective are N95 that are now readily available, that’s the kind of mask you should wear,” he added. But the agency doesn’t make a broad recommendation for everyone to adopt masks. Morris Brown College in Atlanta announced a return to mandated physical distancing and masks just one week after classes started in August. And pediatricians are poised for the typical return-to-school surge in all kinds of respiratory illness, whether colds, flu or Covid. “The virus is always lurking, waiting for openings, so I think Covid is just going to be a bit of a roller coaster, probably forever,” Wachter said.
Persons: Joe Biden, Jonathan Reiner, , ” Reiner, Biden, , Reiner, Eric Topol, ” Topol, ” What’s, Robert Wachter, ” Wachter, haven’t, Peter Chin, Topol, Dr, Sara Bode, Bode, It’s, , ” Chin, Hong, You’ve, you’ve, Amanda Musa, Brenda Goodman, Deidre McPhillips, Meg Tirrell Organizations: CNN, George Washington University School of Medicine & Health Sciences, US Centers for Disease Control, CDC, Scripps, Research, Covid, Department of Medicine, University of California San, University of California, Morris Brown College, Nationwide Children’s Hospital, American Academy of Pediatrics ’, School Health, Internal Locations: Covid, Florida, University of California San Francisco, San Francisco, Atlanta, Columbus , Ohio, Washington
“The risk is very low,” Dr. Peter McElroy, chief of the malaria branch in the US Centers for Disease Control and Prevention’s Division of Parasitic Diseases and Malaria, told CNN. In an effort to limit its impact in the southeastern US during World War II, particularly around military training bases, the US created the Office of Malaria Control in War Areas in 1942. The April 1945 edition of the Malaria Control in War Areas field bulletin. Malaria was eliminated in the United States in 1951, but modern mosquito control is mostly managed locally. Oxitec also says it’s working on applying the approach to anopheles mosquitoes for malaria control as well.
Persons: , Janneth Rodrigues, Rodrigues, tsuruhatensis, National Institutes of Health’s Dr, Carolina, Dr, Peter McElroy ,, haven’t, McElroy, Wade Brennan, Chandan Khanna, , ” McElroy, Daniel Markowski, ” Markowski, They’re, Markowski, Mury, Sanjay Gupta, Aedes, Oxitec, “ We’ve Organizations: CNN, GSK, Malaria, National Institutes of Health’s, of Malaria, Vector Research, National Institute of Allergy, US Centers for Disease Control, Prevention’s, Sarasota County Mosquito Management, of Malaria Control, CDC, American Mosquito Control Association, Public Health Service, National Library of Medicine, Getty, , CNN Health, Google Locations: Tres Cantos, Madrid, Burkina Faso, Africa, United States, Sarasota, Sarasota , Florida, Atlanta, Sarasota County , Florida, Palm Beach County , Florida, Florida, New Jersey
CNN —The weight loss drug Wegovy was shown to reduce the risk of heart attack, stroke or heart disease-related death by 20% in a major clinical trial in people with cardiovascular disease, the first to show a weight loss drug alone can have such protective effects. It called the five-year trial “Select.”The finding of a 20% reduction in heart risk is higher than many experts had anticipated. A similar trial for the type 2 diabetes drug Ozempic, which uses the same ingredient, semaglutide, previously showed it could reduce cardiovascular risk by 26% — but no trial had yet shown a risk reduction in people without diabetes. It said it will present detailed results from the trial at a scientific conference later this year. It’s awaiting US Food and Drug Administration approval for weight loss as well.
Persons: Wegovy, 2.4mg, , Martin Holst Lange, Novo, Dr, Willa Hsueh, Jena Shaw Tronieri, Sanjay Gupta, Fuller, Steven Nissen, Eli Lilly, It’s, ” Nissen, he’d Organizations: CNN, Novo Nordisk, Diabetes, Metabolism Research, Wexner, The Ohio State University, Clinical Services, Center, Perelman School of Medicine, University of Pennsylvania, Nordisk, CNN Health, Cleveland, Food and Drug
CNN —The US Food and Drug Administration has approved the oral contraceptive Opill for over-the-counter use, making it the first nonprescription birth control pill in the United States, but it will be months before it’s available. The typical combination birth control pill, the most commonly used form of oral contraception, uses both hormones to prevent pregnancy. “People use birth control for things outside of preventing pregnancy like [polycystic ovary syndrome], treating heavy periods, painful periods,” she said. “There’s a lot of uses for it outside of birth control that people also will benefit if they can get it over the counter.”Who can use Opill? This could have a major impact for adolescents and young adults who may not otherwise have the resources to access birth control, according to Brandi.
Persons: Gynecologists, ” ACOG, Carolyn Westhoff, they’re, , , Opill, Kristyn Brandi, Brandi, ” Brandi, Anne, Marie Amies Oelschlager, Amies Oelschlager, Jennifer Robinson, ” Robinson, Frederique, Joe Biden, Court’s Dobbs, Dr, Sanjay Gupta, Meg Tirrell Organizations: CNN, Food and Drug Administration, American College of Obstetricians, FDA, Columbia University, Physicians for Reproductive Health, Gynecology, of Gynecology, Johns Hopkins University, Treasury, Labor, Human, CNN Health Locations: United States, Opill, New Jersey
It was shown in May and in fuller Phase 3 clinical trial results released at the Alzheimer’s Association International Conference on Monday to delay the disease’s progression. More than 6 million Americans are estimated to have Alzheimer’s disease, with about 1 million estimated to be in the early symptomatic stages where these drugs have shown benefit. Both Leqembi and donanemab work by clearing buildups of a protein in the brain called amyloid, a hallmark of Alzheimer’s. It’s been a hypothesis that treating Alzheimer’s earlier with amyloid-clearing drugs would yield better results; Skovronsky said the donanemab trial bore that out. “We could look at people who had mild cognitive impairment, MCI, which is the earliest stage, versus mild Alzheimer’s versus moderate Alzheimer’s,” Skovronsky explained.
Persons: Leqembi, Eli Lilly’s donanemab, Lilly, “ Donanemab, Jennifer Manly, Kacie, , Dr, Gil Rabinovici, Renaud La Joie, Daniel Skovronsky, , Skovronsky, ” Skovronsky, It’s, Eric Widera, Sharon Brangman, University of Wisconsin’s Dr, Nathaniel Chin, Donanemab, Lilly hasn’t, Lawrence Honig, Honig, White, Sanjay Gupta, Deters, ” Lilly, it’s “, it’s, there’s, Joe Montminy Organizations: CNN, Alzheimer’s Association, Food and Drug Administration, American Medical Association, Columbia University Irving Medical Center, University of California, MCI, SUNY, University of Wisconsin’s, Leqembi, FDA, donanemab, CNN Health, ” Manly Locations: Los Angeles,
FDA approves first over-the-counter birth control pill
  + stars: | 2023-07-13 | by ( Carma Hassan | ) edition.cnn.com   time to read: +3 min
CNN —The US Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States. Opill is expected to be available over-the-counter in stores by the end of March 2024. The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers. A recent study showed that it has become harder for women to access reproductive health care services more broadly — such as routine screenings and birth control — in recent years. About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017.
Persons:  “, Patrizia Cavazzoni, , , Frederique Welgryn, Opill, Welgryn, Perrigo, Dr, Sanjay Gupta, , Meg Tirrell Organizations: CNN, Food and Drug Administration, FDA’s Center, Drug, Research, FDA, CNN Health Locations: United States, U.S
CNN —The US Food and Drug Administration is expected to decide on Thursday whether to grant traditional approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease. Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly patients with Alzheimer’s through Medicare, the drug hasn’t been widely used. People with more advanced forms of the disease may not benefit from the drug, he said, and may face increased safety risks. Broad Medicare coverage of Leqembi and similar types of medications to slow the progression of Alzheimer’s disease would probably have a big impact on the program’s spending.
Persons: drugmakers, hasn’t, , ’ ”, Joe Montminy, Lawrence Honig, “ It’s, , Honig, it’s, Leqembi, ” Honig, Georges Naasan, Sue Rottura, ” Drugmaker Eisai, “ You’re, Ivan Cheung, Eisai, ” Montminy, Dr, Sanjay Gupta Organizations: CNN, Food and Drug Administration, Medicare, Services, CMS, Columbia University Irving Medical Center, Alzheimer’s, Behavioral, CNN Health, Kaiser Family Foundation Locations: Mount, Florida
Currently approved medicines for weight loss like Novo Nordisk’s Wegovy are given as once-weekly injections. Novo Nordisk’s Ozempic, which contains the same key ingredient as Wegovy, called semaglutide, and Lilly’s Mounjaro are both approved for Type 2 diabetes but used off-label for weight loss. Weight loss at 36 weeks ranged from 9.4% to 14.7%, compared with 2.3% on placebo, the results showed. Lilly’s is just one of a crop of experimental weight loss drugs seeking to join blockbusters like Wegovy on the market. Novo Nordisk reported results last month showing that a pill version of semaglutide yielded 15% weight loss over 68 weeks, similar to Wegovy’s results.
Persons: Eli Lilly’s, what’s, Lilly, Lilly’s, , Nadia Ahmad, orforglipron, “ you’re, Dr, Sean Wharton, White, Ahmad, it’s, Sanjay Gupta, semaglutide Organizations: CNN, New England, of Medicine, American Diabetes Association, Nordisk’s, Nordisk’s Ozempic, Wharton Medical Clinic, CNN Health, Novo Nordisk, Pfizer Locations: San Diego
Supreme Court temporarily blocks abortion pill restrictions
  + stars: | 2023-04-14 | by ( ) www.cnbc.com   time to read: 1 min
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailSupreme Court temporarily blocks abortion pill restrictionsCNBC's Meg Tirrell joins 'Closing Bell' to report on the Supreme court temporarily blocking abortion pill restrictions.
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailCatalent warns of production issues, finishes day as worst S&P 500 performerCNBC's Meg Tirrell joins 'Closing Bell: Overtime' to report on Catalent and Moderna.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailSarepta shares tumble as concerns mount over FDA approval on gene therapyCNBC's Meg Tirrell joins 'Power Lunch' to discuss the Sarepta's gene therapy for muscular dystrophy, and why the stock is taking a tumble over doubts around Sarepta receiving FDA approval.
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailModerna says there are not enough cases to declare early success for its mRNA flu vaccineCNBC's Meg Tirrell reports on news from Moderna that it will delay results from its flu vaccine trials.
watch nowLife expectancy in the U.S. is between three and five years lower than the average in other high-income countries — and the gap comes in part from misinformation, Food and Drug Administration Commissioner Dr. Robert Califf said. He said there's a need for better regulation, including "specific authorities at FDA, FTC and other areas" to root out misinformation. Food and Drug Administration Commissioner Robert Califf testifies before a Senate Health, Education, Labor, and Pensions hearing to examine an update on the ongoing Federal response to COVID-19, at the U.S. Capitol in Washington, U.S., June 16, 2022. The FDA commissioner spoke about multiple topics including efforts to cut drug prices, a priority for the Biden administration and lawmakers from both parties in Congress. Incentives for researchCaliff is also encouraging the drug industry to consider investments in neglected areas of research.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFDA commissioner says health misinformation is driving U.S. life expectancy downDr. Robert Califf says in an interview with CNBC that better regulation is needed to combat health misinformation that's costing Americans years of life. He also weighs in on what the agency can do about drug pricing, where he wants to see the drug industry focus more, and new drugs for obesity.
Pfizer 's CEO signed on to an industry letter in support of the Food and Drug Administration's authority to regulate drugs after a federal judge in Texas suspended the agency's approval of the abortion pill mifepristone. Albert Bourla was among the more than 200 pharmaceutical company executives who signed the letter after U.S. Judge Matthew Kacsmaryk's controversial ruling on Friday. Kacsmaryk sided with an anti-abortion group, arguing that the FDA rushed its approval process and violated federal standards. Kacsmaryk's decision conflicts with a ruling by a federal judge in Washington state. The dueling orders by two federal judges create a complicated legal standoff that could potentially escalate to the Supreme Court.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailHow America's complex drug supply chain is creating vulnerability in the systemCNBC's Meg Tirrell joins 'Closing Bell Overtime' to discuss intensifying shortages in America for antibiotic prescriptions and generic drugs, the global consequences of local drug manufacturing disruptions, and the need for transparency in drug manufacturing.
Bridgebio shares surge on takeout target hopes
  + stars: | 2023-03-29 | by ( ) www.cnbc.com   time to read: 1 min
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailBridgebio shares surge on takeout target hopesCNBC's Meg Tirrell joins 'Power Lunch' to report on Bridgebio's stock surge and pharma returns.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailGeneric drugs are most likely to face shortages due to market failures in affordabilityCNBC's Meg Tirrell joins 'Closing Bell Overtime' to discuss growing pharmaceutical shortages, increasing debt hindering generic drug availability, and more.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailAntibiotics in short supply: U.S. drug shortages hit record levelCNBC’s Meg Tirrell joins ‘Closing Bell: Overtime’ to report on why there's a shortage of antibiotics in the U.S.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailAntibiotics in short supply: U.S. drug shortages reach historic highHosted by Brian Sullivan, “Last Call” is a fast-paced, entertaining business show that explores the intersection of money, culture and policy. Tune in Monday through Friday at 7 p.m. ET on CNBC. CNBC's Meg Tirrell reports on the antibiotic shortage hitting the U.S.
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