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☆ Supreme Court medication abortion case threatens ‘seismic shift’ in FDA drug approval process, experts warn
▼ + stars: | 2024-03-26 | by ( Meg Tirrell | Tierney Sneed | ) edition.cnn.com time to read: +7 min

If the Supreme Court agrees with the appeals court, the approval of mifepristone could be reset to where it stood before 2016, limiting telehealth access to medication abortion and reimplementing other restrictions. “Nevertheless, drug developers invest in new medicines because, if their investments succeed, FDA’s rigorous drug approvals and subsequent regulatory actions are sturdy enough to facilitate reliable returns. “And without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients.”Of course, if the Supreme Court upholds the appeals court decision, the most immediate impact would be to mifepristone itself. “It is both my hope and my ‘bet’ that the court doesn’t uphold the 5th Circuit on the standing argument,” Cohen wrote. “But I have learned the Supreme Court is hard to predict much of the time.”

Persons: thalidomide, mifepristone that’s, ”, Daniel Grossman, ” Grossman, ” PhRMA, Glenn Cohen, Dr, Sanjay Gupta, Cohen, ” Cohen Organizations: CNN, Food and Drug, Federal Food, FDA, US, University of California San, Reproductive, Guttmacher Institute, Circuit, Appeals, Pharmaceutical Research, Manufacturers of America, Harvard Law School, CNN Health Locations: Massengill, University of California San Francisco, Texas

☆ Weight-loss drug Wegovy can be marketed for heart benefits after FDA label update
▼ + stars: | 2024-03-08 | by ( Meg Tirrell | ) edition.cnn.com time to read: +4 min

The label expansion may improve insurance coverage for Wegovy, which costs more than $1,300 per month out of pocket before any discounts. Many insurers, including Medicare, don’t cover drugs for weight loss, leaving patients scrambling to afford them. “This patient population has a higher risk of cardiovascular death, heart attack and stroke,” he added. More studies need to be done to show whether there are heart benefits for people who haven’t had a cardiac event. Wegovy continues to be in shortage, along with other GLP-1 medicines, as drugmakers struggle to keep up with demand.

Persons: CNN — Wegovy’s, –, Dr, Harlan Krumholz, hasn’t, Eli Lilly, Wegovy, John Sharretts, haven’t, it’s, Sanjay Gupta, Jody Dushay, Beth, Dushay, Novo, Doug Langa, ” Organizations: CNN, US Food and Drug Administration, Yale University, Yale New Haven Hospital, Novo Nordisk, Diabetes, ”, CNN Health, Beth Israel Deaconess Medical Center, Harvard Medical School, Novo Nordisk’s, North America Operations

☆ In Alabama, patients are praying for a change of heart on access to IVF
▼ + stars: | 2024-02-25 | by ( Meg Tirrell | ) edition.cnn.com time to read: +5 min

“It’s just frustrating, and it’s sad, and it’s heartbreaking,” Hardin said Thursday, the same day her clinic, Alabama Fertility Specialists, said it was temporarily stopping in vitro fertilization, or IVF, treatments because of legal risk. “I am a huge follower of Jesus,” said Hardin, who leads a group at her church for people who’ve had fertility issues. Those embryos are kept frozen in storage until they’re transferred in hopes of leading to a new pregnancy, or donated or discarded. The legal limbo has drawn the members of Hardin’s church group to lean on each other even more, she said. In July, she and her husband started the process for IVF, going through egg retrieval and freezing embryos, before she had hip surgery for a genetic condition.

Persons: Paula Jean Hardin, Wes, Hardin, “ It’s, ” Hardin, Jay Mitchell, Tom Parker, ”, Jesus, who’ve, “, –, ” Lauren Pleitz, ” Pleitz, Pleitz, Dr, Sanjay Gupta, ” CNN’s Isabel Rosales, Amanda Musa Organizations: CNN, Alabama Fertility, University of Alabama, Center for Reproductive, CNN Health Locations: Alabama, Tuscaloosa, Birmingham

CNN —The University of Alabama at Birmingham health system is pausing in vitro fertilization (IVF) treatment following an Alabama Supreme Court ruling that found frozen embryos are children, the health system said in a statement to CNN. UAB said it was pausing IVF treatments while it evaluates the court’s decision. In the sole full dissenting opinion to the decision, Alabama Supreme Court Justice Greg Cook warned of the potential consequences. Critics have also expressed concerns the ruling creates a road map that groups and legislators across the country who have previously targeted fertility treatments can now follow. “This cruel ruling, and the subsequent decision by UAB’s health system, are horrifying signals of what’s to come across the country,” she said in her Wednesday statement.

Persons: “, —, Greg Cook, ” Cook, ”, Barbara Collura, ” Collura, Critics, – Organizations: CNN, The University of Alabama, Alabama Supreme, UAB, Alabama’s Medical, University of Alabama, Birmingham Locations: Birmingham, Alabama, UAB, Florida

☆ How to access the new weight loss drugs
▼ + stars: | 2024-02-15 | by ( Andrea Kane | ) edition.cnn.com time to read: +7 min

(CNN) — By now, it is pretty clear that the new weight loss and diabetes medications have achieved blockbuster status. Unlike previous weight loss medications, they are pretty effective at helping people lose weight and keep it off — between around 15% to 20% of body weight — with relatively few side effects (although some people can’t tolerate them, and a fraction of patients experience more severe side effects). Zepbound, the newly approved weight loss drug from Eli Lilly, may be easier to find. “Otherwise, some physicians are prescribing older, generic weight loss medications that can be helpful for some patients.”These drugs are not right for everyoneFor many people, the cultural pressure to look a certain way is high. And join us next week on the Chasing Life podcast when we talk to WeightWatchers CEO Sima Sistani about whether these new weight loss drugs really signal the end of diet culture.

Persons: Sanjay Gupta ”, Eli Lilly, Goldman Sachs, Meg Tirrell John Nowak “, Meg Tirrell, Sanjay Gupta, ” Tirrell, “, ” Eli Lilly, Tirrell, ”, Sima Sistani Organizations: CNN, —, Trilliant Health, Novo Nordisk, US Food and Drug Administration, “, Nordisk, ”

☆ ‘Fleeing under the cover of darkness’: How Idaho’s abortion ban is changing pregnancy in the state
▼ + stars: | 2024-02-10 | by ( Meg Tirrell | John Bonifield | ) edition.cnn.com time to read: +12 min

Caldwell, Idaho CNN —Jen and John Adkins never expected to have to send a package like this. Idaho’s abortion laws meant they had to seek care across state lines after receiving devastating news about a much-wanted pregnancy. “As soon as that ultrasound technician put that wand on my stomach and I saw the baby on the screen, I knew something was wrong,” Jen told CNN. “I was sent home to grieve and mourn and call around to see if we could get an appointment out of state,” Jen said. The move, he said, was for personal reasons: “Boise is a wonderful place in general,” he told CNN via email.

Persons: Idaho CNN — Jen, John Adkins, Jen, John, Julie Lyons, who’s, “, ” Lyons, Jennifer, Jennifer Adkins, they’d, ” Jen, ‘, ’, Turner, ”, ’ ” Jen, Jennifer Adkins ‘, Roe, Wade, wasn’t, that’s, ” John, Jen Adkins, Barton Bishoff, ’ It’s, Lyons, Raul Labrador, Dr, Thomas Lee, Lee, …, he’d “, Sanjay Gupta Organizations: Idaho CNN, FedEx, CNN, Research, US, Walgreens, Bureau of Labor Statistics, Center for Reproductive Rights, Defense, CNN Health Locations: Caldwell, Idaho, Caldwell , Idaho, Boise, Portland , Oregon, Hailey, Sun Valley, Portland, St, Luke’s, Oregon

☆ Tirzepatide: Weight loss drug helps significantly lower blood pressure in adults who are overweight or obese, study finds
▼ + stars: | 2024-02-05 | by ( Mira Cheng | ) edition.cnn.com time to read: +6 min

The participants had their blood pressure monitored for a day before beginning treatment and again after nine months of weekly tirzepatide injections. The results showed a significant decrease in the participants’ systolic blood pressure, the top number in blood pressure readings, which is a strong predictor of heart disease. It works similarly to semaglutide, the active compound in the weight loss drug Wegovy and its sister diabetes drug, Ozempic. Although there are effective blood pressure medications available, only about a quarter of people with hypertension have adequately controlled blood pressure, Hall said. He views the weight loss effect of the drug as a pleasant side effect that will make people more likely to take their medication.

Persons: —, Eli Lilly, ”, Harlan Krumholz, Michael E, Wegovy, it’s, Ania Jastreboff, Hall, Krumholz, tirzepatide, Dr, Sanjay Gupta, CNN’s Meg Tirrell Organizations: CNN, American Heart Association, Food and Drug Administration, Yale University, Department of Medicine, University of Mississippi Medical Center, Yale Obesity Research Center, CNN Health Locations: United States

☆ Trial confirms heart benefits of Wegovy, but is weight loss responsible – or something else?
▼ + stars: | 2023-11-11 | by ( Meg Tirrell | ) edition.cnn.com time to read: +9 min

To cardiologist Dr. Steven Nissen of the Cleveland Clinic, who wasn’t involved in the trial but is leading a similar one of tirzepatide, those effects are all evidence of the benefits of weight loss. Tirzepatide has shown greater levels of weight loss than semaglutide in clinical trials, leading many, including Nissen, to hope it will show even stronger cardiovascular benefits. Importantly, participants didn’t have a history of diabetes; a previous trial had shown that treating people with diabetes with a GLP-1 drug, Ozempic, reduced their cardiovascular risk. The Wegovy trial showed that 569 of 8,803 people taking the drug had a heart attack or stroke or died from heart-related causes, or 6.5%. The amount of weight loss seen in the trial, 9.4%, was less than in other studies of Wegovy, which showed average weight loss closer to 15%.

Persons: Ania Jastreboff, Wegovy, Dr, Amit Khera, National Institutes of Health’s Dr, Tiffany M, Powell, Wiley, Eli Lilly, Steven Nissen, wasn’t, ” Nissen, “, Tirzepatide, Nissen, Michael Lincoff, Lincoff, ”, Jastreboff, Sanjay Gupta, hadn’t, “ semaglutide Organizations: CNN, Nordisk’s Wegovy, American Heart Association, Yale Obesity Research Center, University of Texas Southwestern Medical Center Dallas, National Institutes of Health’s, New England, of Medicine, US Food and Drug, Cleveland Clinic, Novo Nordisk, Cleveland, CNN Health Locations: Philadelphia, Powell

☆ Speaker Mike Johnson's 'adopted' Black son said he would 'probably be in prison' if not for him
▼ + stars: | 2023-11-04 | by ( Alia Shoaib | ) www.businessinsider.com time to read: +3 min

House Speaker Mike Johnson's "adopted" Black son has spoken publicly about him for the first time. Michael Tirrell James told DailyMail.com he would "probably be in prison" if it wasn't for Johnson. AdvertisementAdvertisementRepublican House Speaker Mike Johnson's "adopted" Black son has spoken publicly about him for the first time, following reports questioning why he has stayed out of the spotlight. I would probably be in prison, or I might not have made it at all," James told the outlet. "I always felt loved like I was a part of their family," James told DailyMail.com.

Persons: Mike Johnson's, Michael Tirrell James, DailyMail.com, Johnson, —, James, didn't, Michael, Kelly, he's, Corinne Day, Sandra Bullock Organizations: Service, The New York Times, Newsweek Locations: Baton Rouge, Louisiana

☆ Murky road ahead for Duchenne gene therapy as confirmatory trial misses main goal
▼ + stars: | 2023-10-31 | by ( Meg Tirrell | ) edition.cnn.com time to read: +4 min

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

☆ British health agency warns of fake Ozempic pens linked to hospitalizations
▼ + stars: | 2023-10-26 | by ( Amanda Musa | ) edition.cnn.com time to read: +3 min

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

☆ European regulators warn of fake Ozempic pens found at wholesalers in EU, UK amid shortage
▼ + stars: | 2023-10-18 | by ( Meg Tirrell | ) edition.cnn.com time to read: +2 min

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

☆ Novo Nordisk, the maker of Wegovy and Ozempic is now Europe's most valuable company
▼ + stars: | 2023-09-05 | by ( Hanna Ziady | ) edition.cnn.com time to read: +4 min

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

☆ Weight-loss drug Wegovy produces ‘largest benefit ever seen’ for patients with most common form of heart failure, trial finds
▼ + stars: | 2023-08-25 | by ( Meg Tirrell | ) edition.cnn.com time to read: +5 min

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

☆ It may be time to break out the masks against Covid, some experts say
▼ + stars: | 2023-08-23 | by ( Sandee Lamotte | ) edition.cnn.com time to read: +9 min

“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 US eliminated malaria in 1951. How can it keep it under control now?
▼ + stars: | 2023-08-16 | by ( Meg Tirrell | ) edition.cnn.com time to read: +10 min

“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

☆ Wegovy shown to reduce risk of heart attack, stroke in major cardiovascular trial
▼ + stars: | 2023-08-08 | by ( Meg Tirrell | ) edition.cnn.com time to read: +3 min

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

☆ Opill: The FDA approved the US’ first over-the-counter birth control pill. What happens next?
▼ + stars: | 2023-07-21 | by ( Amanda Musa | ) edition.cnn.com time to read: +8 min

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

☆ Second Alzheimer’s drug to slow disease’s progression may be approved in the US this year
▼ + stars: | 2023-07-17 | by ( Meg Tirrell | ) edition.cnn.com time to read: +12 min

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

☆ Daily pill from Eli Lilly leads to 15% weight loss in midstage study, rivaling Wegovy results without the shot
▼ + stars: | 2023-06-23 | by ( Meg Tirrell | ) edition.cnn.com time to read: +4 min

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.

☆ Catalent warns of production issues, finishes day as worst S&P 500 performer
▼ + stars: | 2023-04-14 | by ( ) www.cnbc.com time to read: 1 min

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.

☆ Sarepta shares tumble as concerns mount over FDA approval on gene therapy
▼ + stars: | 2023-04-13 | 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 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.

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