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The rollout of a new round of Covid vaccines in the U.S. is off to a bumpy start as some patients report delays in health insurance coverage for the shots. Private insurance plans and government payers such as Medicare are required to cover the new jabs from Pfizer and Moderna , which became available late last week. It also comes after a huge shift in how Covid vaccines are covered in the U.S. Previously, the federal government purchased Covid vaccines directly from manufacturers at a discount to distribute to all Americans for free. Sarah Lindsey, an owner of a Florida-based jewelry store, called on her own insurer to add the new Covid shots to its formulary.
Persons: Sarah Lindsey, it's Organizations: Pfizer, Moderna, Medicare, Medicaid Services, CVS, U.S, CNBC Locations: U.S, Florida
Uninsured Americans can now get the newest Covid vaccines for free at certain locations across the country, just days after U.S. regulators greenlit those shots for most people. That filter specifically shows locations participating in the Biden administration's Bridge Access Program, which will provide free Covid vaccines and treatments to uninsured people through December 2024. The Bridge Access Program aims to maintain broad access to Covid products after a big shift in how the U.S. covers them. Previously, the federal government purchased Covid vaccines directly from manufacturers at a discount to distribute to all Americans for free. Meanwhile, the Bridge Access Program is aiming to fill the gap for the estimated 30 million uninsured Americans.
Organizations: Pfizer, Moderna, Centers for Disease Control, Walgreens, Biden Locations: U.S
Eli Lilly on Tuesday sued 10 medical spas, wellness clinics and compounding pharmacies across the U.S. for allegedly selling cheaper, unauthorized versions of the company's diabetes drug Mounjaro. Eli Lilly specifically accuses the spas, clinics and compounding pharmacies of marketing and selling "compounded" drug products that claim to contain tirzepatide, the active ingredient in Mounjaro. Compounded drugs are custom-made versions of a treatment that are not approved by the U.S. Food and Drug Administration. The FDA has not issued a warning about compounded versions of tirzepatide. However, Mounjaro, Ozempic and Wegovy have all been in short supply in the U.S. since last year, according to the FDA's database.
Persons: Eli Lilly, Eli Lilly grapples, Ozempic Organizations: Novo Nordisk, Pharmacy, U.S . Food, Drug Administration, FDA Locations: Provo , Utah, U.S, Florida , Texas , Arizona, Georgia, Minnesota, South Carolina, Utah, Florida
For the first time ever, vaccines for Covid, the flu and respiratory syncytial virus are available in the U.S.Public health officials are urging eligible Americans to take all three shots so the nation can avoid another "tripledemic" of Covid, flu and RSV, which inundated hospitals last fall and winter. Most people only need to consider whether they should get an updated Pfizer or Moderna Covid shot and a flu vaccine at the same time, since both are broadly available to all Americans. A maternal vaccine from Pfizer protects infants against RSV, but that shot isn't available just yet. Health experts told CNBC that they don't expect any issues with taking all three shots at once. Still, other experts note that there is little research on administering an RSV shot with another vaccine, or on giving all three shots together.
Persons: Dr, Ali Alhassani, Andrew Pekosz Organizations: Public, Pfizer, Moderna, GSK, CNBC, Boston Children's Hospital, Johns Hopkins Bloomberg School of Public Health Locations: U.S, Boston
Brian Cassella | Tribune News Service | Getty ImagesA new round of Covid vaccines is finally here in the U.S. Meanwhile, the FDA is still reviewing a third updated vaccine from Novavax for people ages 12 and up. Here's everything you need to know about the updated Covid vaccines, from where to find them, whether you can get them for free and when to get them. The agency's website outlines more specific guidelines for staying up to date on Covid vaccines, which differ depending on age group and risk level. Kroger Americans will soon be able to use the federal website vaccines.gov to find other locations offering the updated Covid shots, according to a CDC spokesperson.
Persons: Brian Cassella, Covid, Biden, Megan Wallace, they've, Brian Snyder, vaccines.gov, Evelyn Twentyman, Will, Moderna's, Twentyman, Taison Bell, Bell, CDC's Wallace, Wallace Organizations: Pfizer, Tribune, Service, U.S, The, Disease Control, Moderna, Food and Drug Administration, CDC, FDA, Walgreens, CNBC, WALGREENS, CVS Albertsons, Kroger, Manufacturers, CVS, University of Virginia Health, Younger Locations: Chatham , Illinois, U.S, Covid, Somerville , Massachusetts
Wednesday's results are also a sigh of relief for Moderna after the company pushed back its experimental flu shot program in April. Moderna compared the flu vaccine, dubbed mRNA-1010, to a currently approved seasonal flu vaccine from GlaxoSmithKline called Fluarix. Moderna's flu shot also generated higher seroconversion rates, which refers to the development of specific antibodies against a virus. Also on Wednesday, Moderna said it is ending a separate phase three trial on the first version of its flu vaccine. "With today's positive phase 3 flu results, along with previous results in Covid and RSV, we are now three for three on advancing respiratory disease programs to positive phase 3 data."
Persons: Moderna, Stephane Bancel Organizations: Moderna, U.S, GlaxoSmithKline, World Health Organization –, Food and Drug Administration, FDA, Pfizer, GSK Locations: Moderna, Covid
The main ingredient used in many popular over-the-counter cold and allergy medications doesn't actually work to get rid of nasal congestion, an advisory panel to the Food and Drug Administration declared Tuesday. The FDA typically follows the advice of its advisory committees but it is not required to do so. Pulling phenylephrine from the market could also affect retail pharmacy chains, which rake in revenue from selling over-the-counter cold and allergy pills. Retail stores in the U.S. sold 242 million bottles of drugs containing phenylephrine last year, up 30% from 2021, according to data compiled by FDA staff. Yet FDA staff, in briefing documents posted ahead of the meeting this week, concluded that oral formulations of phenylephrine don't work at standard or even higher doses.
Persons: Johnson, Scott Melville Organizations: Food and Drug Administration, FDA, Procter, Gamble, Consumer Healthcare Products Association, CVS, Walgreens, University of Florida Locations: U.S
An independent advisory panel to the Centers for Disease Control and Prevention on Tuesday recommended that all Americans ages 6 months and up receive updated Covid vaccines from Pfizer and Moderna , the next step toward the shots reaching Americans in the coming days. Thirteen advisors voted in favor of that "universal" recommendation for Americans, while one voted against it. It is a vaccine-preventable disease," said Dr. Beth Bell, clinical professor at the University of Washington and member of the panel, during the advisory meeting. "And so, for that reason, I favor the universal recommendation." The advisory panel's "universal" recommendation comes a day after the Food and Drug Administration approved the two mRNA jabs, which are designed to target the omicron subvariant XBB.1.5.
Persons: Mandy Cohen, Georgina Peacock, Beth Bell, Hospitalizations, hospitalizations, Megan Wallace Organizations: Moderna, Pharmacy, Centers for Disease Control, Pfizer, CDC, University of Washington, Food and Drug Administration, FDA Locations: Schwenksville , Pennsylvania, U.S
The Food and Drug Administration on Monday approved updated Covid vaccines from Pfizer and Moderna , putting the shots on track to reach Americans within days as U.S. hospitalizations from the virus rise. The updated vaccines from Pfizer and Moderna won't be available to Americans just yet. The Biden administration said in August that it expects new single-strain vaccines from Pfizer, Moderna and Novavax targeting XBB.1.5 to be available to the public in mid-September. The upcoming arrival of updated vaccines offers some reassurance to Americans as the nation sees an increase in Covid cases and hospitalizations. Bourla and Moderna CEO Stéphane Bancel, in a separate statement, urged Americans to receive their updated Covid shot during the same appointment as their annual flu shot.
Persons: Biden, Pfizer's, Albert Bourla, Stéphane Bancel, hospitalizations Organizations: Pfizer, BioNTech, Peabody Institute Library, Drug Administration, Moderna, FDA, CDC, Covid, EG Locations: Peabody , Massachusetts, U.S
Jaap Arriens | Nurphoto | Getty ImagesHeather Le Biller shed 9 pounds within the first week of taking Novo Nordisk 's blockbuster diabetes drug Ozempic – and then even more as she continued treatment. That means it could take years before the Food and Drug Administration and other regulators worldwide approve drugs like Ozempic and Wegovy as addiction treatments. Jerlhag and her colleagues at the University of Gothenburg in Sweden have studied the effect of GLP-1s on addictive behaviors for more than a decade. "The mechanism in the brain that regulates overeating is important in regulating addictive behaviors as well," Leggio told CNBC. Still, NIDA's Leggio advises against using GLP-1s off-label to reduce addictive behaviors, "simply because there's not enough evidence in humans that they work."
Persons: Jaap Arriens, Heather Le Biller, Ozempic –, Le Biller, they're, Angela Fitch, Brandon Bell, Dr, Lorenzo Leggio, semaglutide, , Eli Lilly, pharmacologist, Jerlhag, George Frey, NIDA's, Leggio, Steven Batash, Batash, NIDA's Leggio Organizations: Nurphoto, Novo Nordisk, CNBC, Wegovy, Obesity Medicine Association, and Drug Administration, Pharma, National Institute on Drug, University of Gothenburg, Company, Reuters, Brigade, Getty Locations: Riga, Latvia, France, Ozempic, Novo, U.S, Italian, Austin , Texas, Sweden, Provo , Utah, Queens , New York
In this photo illustration, the Kroger Company logo is displayed on a smartphone screen. Kroger on Friday said it has agreed to pay $1.2 billion to U.S. states, subdivisions and Native American tribes to settle the majority claims that it fueled the opioid epidemic through lax oversight of its pill sales. That settlement would allow for "full resolution" of all claims on behalf of those parties, Kroger said in a release ahead of its second-quarter earnings. Still, the company said the settlement is not an admission of wrongdoing or liability. "Kroger will continue to vigorously defend against any other claims and lawsuits relating to opioids that the final agreement does not resolve," the company said in the releaseThis is breaking news.
Persons: Kroger Organizations: Kroger Locations: U.S
Carl Icahn on Thursday expressed his support for Illumina 's new CEO Jacob Thaysen – a relief for the company as it tries to rebound from a bitter proxy fight with the billionaire activist investor. "I think he will do an excellent job and he has my full support," Icahn said in a post on X, noting that he spoke with Thaysen. Icahn, who continues to own a small stake in Illumina, launched a proxy battle over the company's decision to close its $7.1 billion acquisition of cancer test developer Grail in 2021 without approval from antitrust regulators in U.S. and European Union. Icahn was a staunch critic of Illumina's former CEO Francis deSouza, who ultimately resigned after the proxy battle in May despite securing enough votes to stay. "I'd find it comical, if it wasn't so reprehensible that ILMN's share price is down 63% due to CEO Francis deSouza making such an absurd and questionable purchase," Icahn said in a statement to CNBC in March.
Persons: Carl Icahn, Jacob Thaysen –, Icahn, Thaysen, Francis deSouza Organizations: Union, CNBC Locations: Illumina
Moderna 's new Covid vaccine produced a strong immune response against BA.2.86, a highly mutated omicron variant that health officials are watching closely, according to clinical trial data the biotech company released Wednesday. The updated shot produced an 8.7-fold increase in protective antibodies against BA.2.86, which has been detected in small numbers nationwide. Moderna is the first out of the companies producing updated Covid jabs to release data on how its shot fares against BA.2.86. Last month, Moderna also released clinical trial data suggesting that its new shot provides protection against the now-dominant EG.5, or "Eris," variant and another rapidly spreading strain called FL.1.5.1. New vaccines are set to arrive as Eris and other Covid variants fuel a rise in cases and hospitalizations across the country.
Persons: Stephen Hoge, Covid hospitalizations Organizations: Disease Control, Moderna, Pfizer, Novavax, U.S . Food, Drug Administration, EG, CDC Locations: U.S
That includes the agency's examination of Pfizer 's proposed $43 billion purchase of cancer drug developer Seagen . Some also speculated that the restrictions imposed on Amgen as part of the settlement could have implications for other deals. The FTC's lawsuit against Amgen in May was the agency's first legal challenge to a pharmaceutical buyout in 14 years. The settlement agreement prohibits Amgen from bundling any of its products with two of Horizon's blockbuster drugs, among other restrictions. Still, some analysts said the restrictions suggest the FTC could apply similar rules to other buyouts in the future.
Persons: Amgen, William Blair, Matt Phipps, Robyn Karnauskas, baring, Nathan Ray, West, Biden, Evan Seigerman Organizations: Federal Trade Commission, Horizon Therapeutics, Pfizer, FTC, West Monroe, Amgen, Pharmaceutical, Pharma, BMO Capital Locations: Amgen
Illumina 's board on Tuesday named Jacob Thaysen the DNA sequencing company's new CEO as it tries to rebound from a grinding dispute over its acquisition of cancer test developer Grail. Thaysen, a 48-year-old longtime executive at medical devices firm Agilent , will step in as CEO on Sept. 25. His nomination comes months after a bitter proxy fight with activist investor Carl Icahn ended with Illumina's former CEO Francis deSouza resigning despite securing enough votes to stay. "Jacob's unique combination of deep technological and commercial experience will be a great addition to Illumina," Stephen MacMillan, the chair of Illumina's board, said in the release. Thaysen will take over for Charles Dadswell, who has been serving as Illumina's interim CEO since June.
Persons: Illumina, Jacob Thaysen, Carl Icahn, Francis deSouza, Icahn, Thaysen, Stephen MacMillan, Charles Dadswell, Dadswell Organizations: Union, European Commission, U.S . Federal Trade Commission, Illumina Locations: Illumina, San Diego , California, U.S, Agilent
As Covid cases surge again in the U.S., Americans are digging out unused at-home tests that they stashed earlier on in the pandemic. If the date has not changed, the FDA advises against using expired tests. Public health experts say testing remains a critical tool for protection as Covid metrics climb. However, certain local health clinics and community sites still offer at-home tests to the public at no cost. Before buying new at-home tests, it wouldn't hurt to check if any expired ones sitting in your medicine cabinet are still safe to use.
Persons: Abbott's, Andrew Pekosz, Covid hospitalizations Organizations: Drug Administration, Johns Hopkins Bloomberg School of Public Health, CNBC, FDA, Centers for Disease Control Locations: Orlando, U.S
An uptick in Covid cases and hospitalizations in the U.S., and the emergence of new variants of the virus, are prompting questions about whether Americans should start masking up again. One thing's for sure: People infected with Covid should wear masks around others to prevent the spread of the virus. That includes your personal risk level, Covid rates in your region and who you might make contact with, public health experts said. Newer Covid variants like the now-dominant EG.5, or "Eris," and a handful of XBB strains have fueled the rise. New Covid shots from Pfizer , Moderna and Novavax are slated to roll out in mid-September, and will likely provide robust protection against those variants.
Persons: Michael Nason, Donna Nason, Andrew Pekosz, Francesca Torriani, Pavitra, Axios Organizations: Centers for Disease Control, Johns Hopkins Bloomberg School of Public Health, CNBC, CDC, U.S, Pfizer, Moderna, University of California, University of Washington School of Medicine Locations: Bakersfield, Los Angeles , CA, California, U.S, Covid, San Diego
The Federal Trade Commission on Friday said it has reached a deal with drug giant Amgen to allow the company's $27.8 billion purchase of Horizon Therapeutics to move forward. The two companies now expect to close the acquisition – Amgen's largest ever – early in the fourth quarter of this year, a spokesperson for Amgen said. But the agreement announced Friday still imposes restrictions on Amgen to address key concerns the FTC raised in its suit. That practice involves offering rebates or discounts on its existing products to pressure insurers and pharmacy benefit managers into favoring the Horizon products. A Horizon spokesperson did not immediately respond to a request for comment.
Persons: Amgen Organizations: Federal Trade Commission, Horizon Therapeutics, FTC Locations: Thousand Oaks , California, California , Illinois, Minnesota , New York, Washington, Wisconsin
Ozempic, the blockbuster diabetes treatment from Novo Nordisk , could be next in line in the price negotiations between manufacturers and Medicare. Ozempic will likely be eligible for negotiations by the time the next round of drugs is selected in 2025, for price changes that will go into effect in 2027. Novo Nordisk's Rybelsus, a diabetes drug taken orally, could also be on the list because it contains the same active ingredient as Ozempic. A spokesperson for Novo Nordisk didn't directly comment on the potential for Ozempic to be included in the next round of talks. Medicare and private insurers typically secure discounts and rebates on the drugs they cover, but it's unclear how large they are.
Persons: Biden, Ozempic, Cantor Fitzgerald, Louise Chen, Elon Musk Organizations: Novo Nordisk, Pharmacy, Ozempic, CNBC, Novo Nordisk's Rybelsus, Medicare, Services, Elon Locations: Provo , Utah, U.S, Novo
Beneath the trimmed flower is a tray collecting shake, cannabis flower that has naturally broken down through handling. Marijuana is currently a Schedule I drug under the Controlled Substances Act, meaning it's deemed to have no currently accepted medical use and a high potential for abuse. The news sent shares of several cannabis companies, including Canopy Growth , Tilray Brands and Cronos Group , jumping Wednesday. "Certainly, moving cannabis off of Schedule 1 is the right decision and long overdue," Rea said in a statement. "Though a full descheduling would be preferred and likely most appropriate for cannabis, we welcome smart decisions and progress towards full legalization and regulation in the legal cannabis industry."
Persons: James Romano, Patrick Rea, Rea Organizations: U.S . Department of Health, Human Services, Drug, Administration, CNBC, Wednesday, Marijuana, Tilray Brands, Cronos, Bloomberg, HHS, DEA, Poseidon Garden Ventures Locations: Medway, U.S
But analysts say the drug price talks will likely have a muted financial impact on manufacturers, at least for this first round of prescription medicines. More broadly, some of the drugs on the list aren't significant contributors to their company's business in the first place. "The commercial impact of negotiations appears limited in the near term for this initial list of drugs," Mara Goldstein, managing director of Mizuho Securities, told CNBC. The list names drugs with the highest spending for Medicare Part D, which covers prescription medications, from June 2022 to May 2023. Several drugmakers, including a handful whose medications are on the list, have filed lawsuits in different federal courts seeking to stop the negotiations.
Persons: Eliquis, Mara Goldstein, Biden, Johnson, there's Organizations: New, Halsted Pharmacy, Medicare, Mizuho Securities, CNBC, Myers Squibb, Johnson, Merck, AstraZeneca, Supreme, U.S . Chamber of Commerce Locations: Chicago , Illinois, Bristol, U.S
Bottles of the drug Jardiance, made by Eli Lilly and Company, sit on a counter at a pharmacy in Provo, Utah, January 9, 2020. Two blood thinners and a diabetes medication are the drugs most widely used by Medicare beneficiaries among a list of 10 drugs that will be subject to price negotiations between manufacturers and Medicare. The list names drugs with the highest spending for Medicare Part D, which covers prescription medications, for the period from June 1, 2022, to May 31, 2023. Nearly 1.6 million Medicare enrollees used Jardiance during the same time period, according to the fact sheet. Medicare Part D also spent more on those three drugs during the time period than it did on the seven other medicines on the list.
Persons: Eli Lilly, Biden, Myers Squibb, enrollees, Johnson Organizations: Company, U.S, Medicare, Myers, Centers, Services, Pfizer Locations: Provo , Utah, Bristol
Fiasp and NovoLog, insulins made by Novo Nordisk The Medicare negotiations are the centerpiece of the Biden administration's efforts to rein in the rising cost of medications in the U.S. Drugmakers such as Merck and Johnson & Johnson and their supporters aim to derail the negotiations, filing at least eight lawsuits in recent months seeking to declare the policy unconstitutional. Drugmakers' legal challengesMerck, Johnson & Johnson, Bristol-Myers Squibb and Astellas Pharma are among the companies suing to halt the negotiation process. The suits make similar and overlapping claims that Medicare negotiations are unconstitutional. Biden and his top health officials have embraced the lawsuits as evidence that they're making progress in the fight to cut drug prices.
Persons: Biden, Joe Biden's, Boehringer Ingelheim, Johnson Januvia, Merck Farxiga, Novartis Enbrel, Amgen Imbruvica, AbbVie Stelara, Janssen, insulins, Johnson, Leigh Purvis, Drugmakers, drugmakers, Robert Davis Organizations: Bristol, Myers Squibb Jardiance, Johnson, Merck, AstraZeneca Entresto, Novartis, Novo Nordisk, Medicare, Centers, Services, Biden, AARP Public, Institute, Congressional, Office, Myers Squibb, Astellas Pharma, U.S . Chamber, Commerce, Supreme, Court, Circuit Court, Pharma, White, Big Pharma Locations: U.S, Bristol
Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc. Adderall and alternative ADHD medications apart from other drugs are Schedule 2 controlled substances. Production limitationsEnding the shortages of Adderall and other ADHD medications is no easy task. That means increasing the production of one drug could potentially require reducing production — and potentially impacting supply — of another drug, according to Ergun. That includes Aytu BioPharma, which makes an ADHD drug that used to be in shortage.
Persons: Jb Reed, It's, Erin Fox, they've, David Margraf, Margraf, drugmakers, Ozlem Ergun, Ergun, Novartis's, Michael Ganio, ASHP's Ganio, RJ Sangosti, Josh Disbrow, Fox Organizations: Shire Plc, Jb, Bloomberg, Getty, and Drug Administration, CNBC, University of Utah, American Society of Health, System Pharmacists, Centers for Disease Control, University of Minnesota's, Infectious Disease, Northeastern University, Teva Pharmaceuticals, Amneal Pharmaceuticals, Sandoz, Purdue Pharma, Rhodes Pharmaceuticals, Drug, Fox, Pharmacists, Drug Enforcement Administration, MediaNews, Denver, FDA, DEA Locations: U.S, Commerce City , Colorado
A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, March 31, 2023. Wegovy, the popular weight loss drug from Novo Nordisk , significantly reduced symptoms of a common type of heart failure in patients with obesity, according to a late-stage clinical trial released Friday. Wegovy helped alleviate symptoms like shortness of breath, fatigue, swelling in the legs and irregular heart beat. There were fewer serious safety events in patients who took Wegovy compared to those who took the placebo. But more patients stopped taking Wegovy because of gastrointestinal issues, which are commonly observed with other weight loss drugs.
Persons: Wegovy, Martin Lange, Novo, Ozempic Organizations: Wegovy, Novo Nordisk, Novo Nordisk's, New England, of Medicine, Nordisk Locations: Chicago , Illinois, Novo, U.S
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