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The Centers for Disease Control and Prevention expects updated Covid vaccines from Pfizer , Moderna and Novavax to be available to the public in mid-September, an agency official told reporters Thursday. CDC Director Mandy Cohen had previously provided a later timeline, telling NPR that the vaccines could be available by the "early October time frame." Those shots still need approvals from the Food and Drug Administration and the CDC, which will set eligibility guidelines for the jabs. Officials from the CDC and FDA said the agencies will encourage Americans to receive an updated Covid shot and other key vaccines ahead of the fall, when respiratory viruses typically begin to spread more widely. "Our goal, our imperative, our task is to make sure we're using those tools," the CDC official said.
Persons: Mandy Cohen Organizations: Disease Control, Pfizer, Moderna, Federal, NPR, Food and Drug Administration, CDC, FDA
Shares of Novavax jumped more than 13% on Tuesday after the biotech company said its new Covid vaccine generated a broad immune response against the now-dominant Eris variant and another fast-spreading strain of the virus in small animal trials. But the trial results suggest that the shot may still be effective against newer Covid variants gaining a greater foothold in the U.S. That includes Eris and XBB.1.16.6, both of which are also descendants of omicron. "We have a lot of confidence in our updated Covid vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall," Filip Dubovsky, Novavax's president of research and development, said in a release. The World Health Organization designated Eris a "variant of interest," meaning it will be monitored for mutations that could make it more severe. XBB.1.16.6 is also beginning to surge, accounting for 8% of all cases nationwide as of Saturday, the CDC said.
Persons: Novavax, Filip Dubovsky Organizations: Pfizer, Moderna, U.S . Food, Drug Administration, EG, Centers for Disease Control, World Health Organization, CDC Locations: U.S, hospitalizations
It's now the second treatment approved by the FDA to prevent RSV in infants and the first vaccine. It uses maternal immunization, which refers to vaccinating pregnant mothers so they can pass protective antibodies to their fetuses. "When you think globally, this vaccine could potentially have a huge public health impact," Gurtman told CNBC. The FDA in mid-July approved an RSV monoclonal antibody from Sanofi and AstraZeneca that is directly administered to infants. The shot would help the U.S. combat the upcoming RSV season as it comes off an unusually severe year.
Persons: It's, Alejandra Gurtman, Gurtman, Dr, Peter Marks Organizations: Drug Administration, Pfizer, FDA, Centers for Disease Control, Prevention, CNBC, Sanofi, AstraZeneca, CDC Locations: U.S
Covid vaccine makers' shares rose Monday as new variants of the virus emerge in the U.S. ahead of the rollout of updated shots this fall. Shares of BioNTech , which jointly develops Covid vaccines with Pfizer , popped nearly 7%. It's been a rocky few months for those stocks as sales of Covid shots and treatments plummet in the U.S.: Shares of all four companies are down more than 20% for the year. But Wall Street's enthusiasm for Covid vaccine makers is getting a fresh boost with the upcoming launch of brand-new shots this fall and the emergence of new variants of the virus. So far, there is no evidence that BA.2.86 spreads faster or causes more serious infections than previous versions.
Persons: Novavax, It's Organizations: Pfizer, EG, U.S . Health, CNBC, Moderna, Novavax, World Health Organization, U.S . Centers for Disease Control, Prevention Locations: U.S, Denmark, Israel
Drugmaker Teva Pharmaceuticals agreed to pay $225 million in criminal fines over five years and divest its version of a generic cholesterol drug to resolve charges related to price-fixing on that medication and other widely used treatments, the Department of Justice announced Monday. Teva, in a press release Monday, said it will pay $22.5 million each year from 2024 through 2027, and $135 million in 2028. Glenmark Pharmaceuticals will pay $30 million to resolve similar charges. Since 2020, the DOJ's antitrust division has charged five other pharmaceutical companies for participating in similar schemes affecting several generic drugs. Teva has also agreed to donate $50 million worth of two generic drugs affected by price-fixing to humanitarian organizations that provide medications to Americans in need.
Persons: Drugmaker, Teva, Jonathan Kanter, Glenmark, Apotex Organizations: Drugmaker Teva Pharmaceuticals, Department of Justice, Glenmark Pharmaceuticals, Antitrust Division, DOJ, Eastern District of Pennsylvania, Apotex Corp Locations: Eastern District
George Frey | ReutersDrugmakers aren't the only ones feeling the impact of the weight loss industry gold rush. Retailers with pharmacy businesses, such as Walmart , Kroger and Rite Aid , said increased demand for prescription weight loss drugs helped boost sales for the second quarter. Are weight loss drugs profitable? A selection of injector pens for the Saxenda weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. For one, branded drugs don't directly compete with other medications because they have patent protections.
Persons: George Frey, Reuters Drugmakers, Arun Sundaram, it's, Elon Musk, Eli Lilly, Doug McMillon, Matthew Schroeder, Schroeder, Rodney McMullen, CFRA Research's Sundaram, Michael Lasser, Jim Vondruska, USC's Schaeffer Organizations: KR NOVO.B, Novo Nordisk, Pharmacy, Reuters, Walmart, Kroger, Rite, CFRA Research, CNBC, Nordisk, Elon, Pfizer, UBS, USC's, USC's Schaeffer Center for Health, Association Locations: Provo , Utah, U.S, GLP, Chicago , Illinois
New Covid vaccines from Pfizer , Moderna and Novavax will likely provide protection against the new "Eris" variant, now the dominant strain of the virus in the U.S. The drugmakers designed their updated vaccines to target the omicron subvariant XBB.1.5, which is slowly declining nationwide. Eris accounted for 17.3% of all cases in the U.S. as of earlier this month, according to the latest data from the CDC. The World Health Organization earlier this month designated Eris a "variant of interest," meaning it will be monitored for mutations that could potentially make it more severe. It's also not expected to cause a huge wave of Covid cases like other strains have in previous years.
Persons: Dr, Mark Mulligan, It's Organizations: Chicago Department of Public Health, Southwest Senior Center, Pfizer, Moderna, U.S, EG, NYU, Vaccine, CNBC, Food and Drug Administration, Disease Control, CDC, World Health Organization Locations: Covid, Chicago , Illinois, Novavax, U.S
Moderna's new Covid vaccine generated a robust immune response against the now-dominant Eris variant and another rapidly spreading strain of the virus in an early clinical trial, the biotech company said Thursday. The updated shot is designed to target omicron subvariant XBB.1.5, but the results suggest that the jab may still be effective against newer variants of the virus that are gaining ground nationwide. That includes Eris and another variant nicknamed Fornax, both of which are also descendants of the omicron virus variant. The World Health Organization designated Eris a "variant of interest," meaning it will be monitored for mutations that could make it more severe. A Pfizer spokesperson on Thursday said the company's own updated Covid shot effectively neutralized XBB.1.5 and Eris, among other variants, in a recent trial on mice.
Persons: Eris Organizations: omicron, Pfizer, Novavax, U.S . Food, Drug Administration, EG, Centers for Disease Control, World Health Organization, CDC Locations: U.S
In this photo illustration, a box of the diabetes drug Ozempic rests on a pharmacy counter on April 17, 2023 in Los Angeles, California. Blockbuster weight loss drugs are priced significantly higher in the U.S. than in other large, high-income countries, according to a new analysis released Thursday. The report from KFF, a health policy organization, comes as many U.S. health insurers balk at the extreme cost of weight loss drugs and drop the medications from their plans. These list prices and the patchy insurance coverage of weight loss drugs in the U.S. undoubtedly impact accessibility. New trial data released by Novo Nordisk last week could potentially put more pressure on U.S. insurers to cover weight loss drugs.
Persons: Eli, Eli Lilly weren't, Wegovy Organizations: Blockbuster, balk, Novo Nordisk, Novo Nordisk's Wegovy, CNBC Locations: Los Angeles , California, U.S, KFF, Novo, Japan, Germany, Sweden, France, Netherlands, Danish
Shares of CVS Health plunged 9% on Thursday after Blue Shield of California said it will drop the company's pharmacy benefit management services and instead partner with Mark Cuban's Cost Plus Drug Company and Amazon Pharmacy to save on drug costs for its nearly 5 million members. Blue Shield will now work with five different companies to provide "convenient, transparent access to medications while lowering costs." Blue Shield CEO Paul Markovich said the plan, which is scheduled to fully launch in 2025, could save the company up to $500 million annually. Cuban's Cost Plus Drug Company will provide access to low-cost medications through retail pharmacies. Blue Shield will retain CVS Caremark for its specialty pharmacy services, which provide specialized therapies and counseling to patients suffering from complex disorders.
Persons: Mark Cuban's, Caremark, Paul Markovich, Michael DeAngelis, Centene Organizations: CVS Health, Drug Company, Amazon Pharmacy, UnitedHealth, CVS, Abarca, Blue, CNBC Locations: New York, California
A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, March 31, 2023. Novo Nordisk's blockbuster weight loss injection Wegovy could prevent up to 1.5 million heart attacks, strokes and other cardiovascular events in the U.S. over 10 years, according to a study released this week. Researchers from the University of California, Irvine, also found that Wegovy could result in 43 million fewer Americans with obesity over a decade. An estimated 83 million Americans without established cardiovascular disease would also experience heart health benefits after taking Wegovy for a decade. Wegovy would reduce the risk of serious heart problems in that population by 17.8%, which translates to 1.5 million preventable heart attacks, strokes and other cardiovascular events.
Persons: Novo, Wegovy, Nathan Wong, Ozempic Organizations: University of California, Novo Nordisk, UC, Wall Street, Disease, Nordisk's, Nordisk Locations: Chicago , Illinois, U.S, Irvine, Danish, UC Irvine's
Young people are at risk of experiencing significant respiratory symptoms, including bronchitis and shortness of breath, after just 30 days of electronic cigarette use, according to a new study released Tuesday. They said the study, partly funded by the National Institutes of Health, contributes to existing evidence that e-cigarette use is associated with an increased risk of respiratory symptoms. Drug regulators should consider the findings and work to minimize the negative health impact of e-cigarette use on young people, the researchers added. E-cigarette usage is now substantially higher among youths and young adults than it is among adults overall in the U.S., according to the Centers for Disease Control and Prevention. She noted that the study examines only teens and young adults, and that in the demographic of all adults, people "often switch from using cigarettes to using e-cigarettes with likely fewer risks."
Persons: Tackett Organizations: Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Southern California Keck School of Medicine, National Institutes of Health, Centers for Disease Control, Manufacturers, Brands, Food and Drug Administration Locations: U.S
The Securities and Exchange Commission is investigating Illumina over its controversial $7.1 billion acquisition of cancer test developer Grail, the DNA sequencing company said in a securities filing late Thursday. Last month, the SEC informed Illumina about the probe and requested documents and communications related to the deal. The company's market value has fallen to roughly $28 billion from around $75 billion the month the deal closed. Illumina's Grail deal has also faced heavy scrutiny from antitrust regulators in the U.S. and European Union. The European Commission, the EU's executive body, fined Illumina a record $476 million last month for closing the acquisition without first securing regulatory approval.
Persons: Illumina, That's, Carl Icahn Organizations: The Securities, Exchange Commission, SEC, Union, The European Commission, Illumina, U.S . Federal Trade Commission Locations: Illumina, San Diego , California, U.S
Novo Nordisk on Thursday said it will acquire Inversago Pharma, a privately held obesity drug maker, for up to $1.08 billion to broaden the Danish company's blockbuster weight loss portfolio. The deal's price depends on whether Inversago reaches certain development and sales goals, Novo Nordisk said in a release. Canada-based Inversago develops experimental therapies to treat people with obesity, diabetes and other conditions affecting the body's metabolism. Meanwhile, Novo Nordisk's Wegovy and Ozempic work by mimicking a hormone produced in the gut to suppress a person's appetite. Novo Nordisk intends to further investigate the potential of the oral drug for obesity and obesity-related complications.
Persons: Novo, Martin Holst Lange, Lars Fruergaard Jorgensen, availabilities Organizations: Novo Nordisk, Inversago Pharma, Novo, Novo Nordisk's Wegovy, Nordisk, Reuters Locations: Danish, Inversago, Canada, U.S
There is likely a long way to go before the U.S. sees increased insurance coverage for obesity drugs. While the trial results demonstrate that obesity drugs may have significant health benefits beyond shedding unwanted pounds, organizations representing U.S. insurers emphasized that the data is still preliminary. "Health insurance providers will continue to analyze new evidence as it becomes available," he added. Ceci Connolly, CEO of the Alliance of Community Health Plans, acknowledged the promise of the data but said "outrageous prices should give everyone pause." The organization represents regional, community-based health plans that cover more than 18 million Americans across the U.S.
Persons: Jim Vondruska, Wegovy, Eli Lilly, David Allen, Ceci Connolly, Jared Holz, It's, Debra Tyler's, Joe Buglewicz, Eduardo Grunvald, George Frey, UCSD's Gunvald, Eli, Ethan Lazarus, Lazarus Organizations: Reuters Novo Nordisk, Novo Nordisk, America's Health, Alliance of Community Health, U.S, Drugs, Pfizer, Medicare, CVS, Aetna, CNBC, Washington Post, Getty, UCSD Health's Center, International Foundation of Employee, University of Texas System, UTS, Novo, Reuters, Obesity Medicine Association, New England, of Medicine Locations: Chicago , Illinois, U.S, Mizuho, Killingworth, Conn, Texas
Shares of Novavax jumped as much as 20% in premarket trading Tuesday after the Covid vaccine maker reported a surprise second-quarter profit. Here's what Novavax reported compared with Wall Street's expectations, based on a survey of analysts by Refinitiv. That compares with a net loss of $510.5 million, or $6.53 per share, reported during the same quarter last year. But Jacobs noted that the adjustment reflects part of a cash settlement the Canadian government agreed to pay for forfeiting Covid vaccine doses that were previously scheduled for delivery. The company reported R&D expenses of $258 million and SG&A expenses of $162 million last year.
Persons: Novavax, John Jacobs, Jacobs, We're, it's Organizations: Refinitiv, CNBC, and Drug Administration Locations: Krakow, Poland
Eli Lilly also increased its adjusted earnings guidance to a range of $9.70 to $9.90 per share for the year, up from a range of $8.65 to $8.85. Shares of Eli Lilly jumped 9% in premarket trading Tuesday. Last month, Eli Lilly filed for Food and Drug Administration approval of the injection for chronic weight management. Eli Lilly said it "has experienced and continues to expect intermittent delays fulfilling orders of certain Mounjaro doses given significant demand." Eli Lilly also reported no sales from its Covid-19 antibody treatments, compared with $129 million in the second quarter of 2022.
Persons: Eli Lilly, Here's, Alimta, Alimta's Organizations: Getty, Refinitiv, Food and Drug, Amphastar Pharmaceuticals, Drug Administration, . Pipeline Locations: U.S
In this photo illustration, the Sage Therapeutics logo of a biopharmaceutical company seen on a smartphone and on a pc screen. Shares of Sage Therapeutics fell more than 50% on Monday after the Food and Drug Administration approved the biotech company's oral drug zuranolone for postpartum depression, but not for major depressive disorder, a bigger potential market. The two companies also applied for approval of zuranolone for major depressive disorder, also known as clinical depression. Zuranolone had the potential for $1 billion in peak sales, compared with $250 million to $500 million for postpartum depression, Jefferies analyst Michael Yee said in a research note Sunday. He said clinical depression "was really the big upside driver here" for the companies, while postpartum depression is "much smaller and may not be hugely profitable."
Persons: Sage, Zuranolone, Jefferies, Michael Yee Organizations: Sage Therapeutics, Food and Drug Administration
The roof of a Pfizer facility shows heavy damage after a tornado passed the area in Rocky Mount, North Carolina, July 19, 2023. Pfizer is limiting the distribution of some drugs manufactured at its plant in Rocky Mount, North Carolina, after the facility was struck by a tornado last month, the company said in a letter to hospitals late Thursday. The letter listed 12 injection products that Pfizer will only distribute through emergency orders "due to their high medical need," effective "immediately and until further notice." It also includes an injection used to treat metabolic acidosis, or the buildup of excess acid in the body due to ailments like kidney failure. Pfizer said last month that the tornado primarily damaged a warehouse facility, which stored raw materials, packaging supplies and finished medicines waiting for quality assurance.
Persons: Meera Bhavsar, Albert Bourla Organizations: Pfizer, American Society of Health Locations: Rocky Mount, North Carolina
Shares of Moderna rose Thursday after the biotech company hiked its full-year outlook for its Covid vaccine, its only marketable product, despite reporting a quarterly loss and sharp drop in revenue. But Moderna hopes to end the sales slump on strong demand for its updated Covid vaccine targeting the omicron subvariant XBB.1.5. The forecast includes around $4 billion in previously announced Covid vaccine purchase agreements and $2 billion to $4 billion in "signed and anticipated" contracts in the U.S. and other markets. Pfizer on Tuesday warned that Covid shot sales in the commercial market are uncertain, adding that vaccination rates will help the company better predict sales for 2023 and beyond. ET, which will likely provide more updates on its upcoming Covid vaccine rollout and drug pipeline.
Persons: Novavax haven't, Mandy Cohen Organizations: Moderna, Pfizer, Novavax, Food and Drug Administration, NPR, Merck Locations: U.S, Union, Massachusetts, Covid
Humana shares rose Wednesday after the health insurer said medical costs came in lower than expected during its second-quarter earnings report. Humana reported a medical loss ratio, the percentage of premiums it spends on medical care, of 86.3% for the second quarter. Humana highlighted a "stabilizing Medicare Advantage utilization environment" based on the most recent claims activity, without elaborating. The company said in June it expected its second-quarter medical loss ratio to be toward the top range of its full-year outlook of 86.3% to 87.3%. Shares are down about 5% for the year after the broader health-care sector took a beating in June, putting the company's market value at around $60 billion.
Persons: Humana Organizations: Humana, UnitedHealth
GlaxoSmithKline on Wednesday sued Pfizer in U.S. court, alleging patent infringement over Britain-based GSK's respiratory syncytial virus vaccine. GSK claims Pfizer's RSV vaccine, Abrysvo, infringes on four of its patents related to the antigen used in its own shot. "Upon information and belief, Pfizer knowingly uses GSK's claimed inventions in Abrysvo without permission," GSK wrote in a scathing complaint filed in federal court in Delaware. They are the first shots approved to prevent RSV, a common respiratory infection that usually causes mild, cold-like symptoms, but more severe cases in older adults and children. Each year, RSV kills 6,000 to 10,000 seniors and a few hundred children younger than 5, according to CDC data.
Persons: infringes Organizations: GlaxoSmithKline, Wednesday, Pfizer, GSK, U.S . Food, Drug Administration, Walgreens Locations: Britain, Delaware
CVS Health is cutting 5,000 jobs to reduce costs as the retail pharmacy giant furthers its push into health-care offerings, a person familiar with the matter told CNBC on Tuesday. The pharmacy chain had about 300,000 employees in the U.S. at the end of last year, according to a securities filing. A CVS spokesperson confirmed the layoffs and said they are not expected to affect "customer-facing colleagues in our stores, pharmacies, clinics, or customer services centers." But CVS has sharpened its focus on health care over the past few years, following similar moves by rivals such as Walgreens and tech giant Amazon . The company moved deeper into patient care with its nearly $8 billion acquisition of health-care provider Signify Health and $10.6 billion deal to buy Oak Street Health, which operates primary care clinics for seniors.
Organizations: CVS, CNBC, Street Journal, Rhode, Walgreens, Oak Street Health Locations: U.S
Pfizer on Tuesday reported second-quarter adjusted earnings that topped Wall Street's expectations, but posted revenue that fell short of estimates as Covid product sales plunged. The company's Covid vaccine raked in $1.49 billion in sales, down 83% from the year-ago quarter. Excluding certain items, the company's earnings per share were 67 cents per share for the quarter. Looking ahead, the New York-based company narrowed its 2023 sales forecast to $67 billion to $70 billion, from a previous forecast of $67 billion to $71 billion. Pfizer reaffirmed its forecast of $13.5 billion in Covid vaccine sales in 2023 and $8 billion in revenue for Paxlovid.
Organizations: Pfizer, Refinitiv, Paxlovid, U.S Locations: New York
Merck on Tuesday reported second-quarter revenue that topped expectations on strong sales of its blockbuster cancer drug Keytruda and HPV vaccine Gardasil. The pharmaceutical giant posted a quarterly loss, however, due to charges associated with the company's acquisition of Prometheus Biosciences earlier this year. Merck swung to a net loss of $5.98 billion, or $2.35 per share, from a net income of $3.94 billion, or $1.55 per share, during the year-earlier period. The loss reflects a $10.2 billion, or $4.02 per share, charge related to the company's acquisition of Prometheus, which specializes in treatments for autoimmune diseases. "What you really see...was long sustained underlying growth, and it was driven by oncology and vaccines, and the Gardasil franchise in vaccines," Merck CEO Robert Davis said in an interview on CNBC's "Squawk Box" on Tuesday.
Persons: Merck, Robert Davis Organizations: Merck, Prometheus Biosciences, Prometheus, Refinitiv Locations: U.S
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