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Showing posts with the label Biotechnology

Sanofi expects infant RSV shot to roll out before respiratory virus season this fall

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[ad_1] A doctor is injecting a vaccine to a baby boy Karl Tapales | Moment | Getty Images Sanofi expects its infant RSV shot to roll out in the U.S. before respiratory virus season this fall, a company spokesperson said Friday. The Food and Drug Administration on Monday approved Beyfortus , a monoclonal antibody that is administered as a single dose to infants before or during their first respiratory syncytial virus season. related investing news The Sanofi spokesperson said the company does not expect any challenges with manufacturing or capacity to meet demand this RSV season. The French drugmaker jointly developed Beyfortus with AstraZeneca , which is based in England. A panel of independent advisors to the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations about how the shot should be administered. Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. The Affordable

Kenvue CEO says consumers are spending on brand-name health products even as they pull back in other areas

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[ad_1] Thibaut Mongon, CEO of Kenvue Inc. a Johnson & Johnson's consumer-health business, speaks during an interview to celebrate its IPO at the New York Stock Exchange (NYSE), May 4, 2023. Brendan Mcdermid | Reuters Most consumers have pulled back on spending as inflation squeezes their wallets, but they have not stopped paying up for brand-name health and personal care products, Kenvue CEO Thibaut Mongon said. Mongon told CNBC on Thursday that consumers are still willing to spend on the company's branded products – even as they reduce discretionary spending at retail stores and trade down on some essential items by changing their usual purchase size or switching brands for lower prices.  The Johnson & Johnson consumer spinoff Kenvue beat second-quarter revenue and adjusted earnings estimates on Thursday, fueled by resilient demand for the company's wealth of widely known brands such as Band-Aid, Tylenol, Listerine, Neutrogena and Aveeno. Still, the co

Pfizer says no major tornado damage to drug manufacturing areas of North Carolina facility

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[ad_1] In this aerial image, damage is seen to a Pfizer pharmaceutical factory after a tornado hit the facility two days earlier, on July 21, 2023 in Rocky Mount, North Carolina. Sean Rayford | Getty Images Pfize r on Friday said there does not appear to be major damage to the drug manufacturing areas of its plant in Rocky Mount, North Carolina , after a tornado hit the facility two days earlier.  The plant supplies nearly 8% of all sterile injectable medicines used in U.S. hospitals, including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers. Pfizer added that the facility manufactures about 25% of the company's sterile injectables.  related investing news An initial assessment found that the tornado primarily damaged a warehouse facility, which stored raw materials, packaging supplies and finished medicines waiting to receive quality assurance, according to Pfizer.  The drugmaker did not say whether it expected that damage to lead to new drug

Johnson & Johnson investors can soon swap their shares for Kenvue stock — here's what you need to know

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[ad_1] Thibaut Mongon, CEO and Paul Ruh CFO of Kenvue Inc. a Johnson & Johnson's consumer-health business, pose together during the company's IPO at the New York Stock Exchange (NYSE) in New York City, U.S., May 4, 2023. Brendan McDermid | Reuters Johnson & Johnson on Thursday said its shareholders will soon be able to swap their shares for stock of Kenvue , which spun out as an independent consumer health company just two months ago. J&J owns nearly 90% of Kenvue shares and plans to reduce its stake through an exchange offer that could launch "as early as the coming days," depending on market conditions, J&J CFO Joseph Wolk said during the company's second-quarter earnings call.  That process, also known as a split-off, will allow J&J shareholders to exchange all or a portion of their shares for Kenvue's common stock. J&J did not provide further details on the planned offer. But Wolk said a split-off is the "most advanta

Johnson & Johnson beats on earnings, hikes full-year guidance as medtech sales surge

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[ad_1] Johnson & Johnson on Thursday reported second-quarter revenue and adjusted earnings that topped Wall Street's expectations, and lifted its full-year guidance as sales from the company's medtech business jumped. The medtech division provides devices for surgeries, orthopedics and vision. The company is benefitting from a rebound in demand for non-urgent surgeries among older adults, who deferred those procedures during the pandemic. That increased demand has been observed by health insurers like UnitedHealth Group and Elevance Health . Here's how J&J results compared with Wall Street expectations, based on a survey of analysts by Refinitiv: Earnings per share: $2.80 adjusted, vs. $2.62 expected Revenue: $25.53 billion, vs. $24.63 billion expected Shares of J&J rose more than 5% in morning trading Thursday. The stock has dropped more than 5% for the year, putting the company's market value at roughly $436 billion.  J&J, whose financial

Pfizer Group B strep vaccine for infants returns encouraging mid-stage trial results

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[ad_1] Streptococcus agalactiae bacteria, responsible for vaginal and urinary tract infections and newborn infections including meningitis and septicemia. Optical microscopy view. Cavallini James | BSIP | Universal Images Group | Getty Images Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results , a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world's first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer's vaccine, which is intended to expedite the development and review of the shot.  Pfizer's single-dose shot generated antibodies that may provide infants with meaningful protection aga

Medicare proposes removing limit on PET scans used to help diagnose Alzheimer's disease

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[ad_1] Jay Reinstein, who suffers from Alzheimer's, sits on a bed after receiving a PET scan at MedStar Georgetown University Hospital in Washington, DC on June 20, 2023.  Michael Robinson Chávez | The Washington Post | Getty Images Medicare plans to expand its coverage of PET scans that are used to help diagnose Alzheimer's disease, a major shift in policy that could make it easier for patients to access new treatments that are entering the U.S. market. The proposal would abolish Medicare's current nationwide policy. Right now, the program for seniors will only cover one PET scan per lifetime for patients participating in clinical trials. The Medicare proposal would allow regional organizations, called Medicare Administrative Contractors, to decide whether to cover the diagnostic tool. These regional contractors make coverage decisions based on whether a services is "reasonable and necessary" for the diagnosis of an illness. Chiquita Brooks-LaSure, head of

Nearly 3 million people cut from Medicaid coverage even though many might still be eligible

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[ad_1] Supporters hold up Save Medicaid signs during the Senate Democrats' news conference at the Capitol with disability advocates to oppose the Republicans' Graham-Cassidy health-care bill. Bill Clark | CQ-Roll Call, Inc. | Getty Images Nearly three million people have been kicked off Medicaid since Covid-19 pandemic protections expired in April, with three-quarters of those individuals losing coverage despite the fact they may still be eligible for the public health insurance program, according to data from health researcher KFF . Medicaid is the public health insurance program for lower-income individuals and families. It is heavily financed by the federal government but largely managed by state governments. The widespread removal of coverage is a worrying trend because people who lose one form of insurance often struggle to find alternative coverage due to the complexity of the U.S. health insurance system, putting them at risk of ultimately becoming uninsured. About

Johnson & Johnson sues Biden administration over Medicare drug price negotiations

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[ad_1] Pavlo Gonchar | LightRocket | Getty Images Johnson & Johnson on Tuesday sued the Biden administration over Medicare's new powers to slash drug prices, making it the third pharmaceutical company to challenge the controversial provision of the Inflation Reduction Act .   The lawsuit filed in federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution. Earlier suits brought separately by drugmakers Merck and Bristol Myers Squibb , as well as by the U.S. Chamber of Commerce and PhRMA , the pharmaceutical industry's largest lobbying group, made similar arguments. J&J's complaint asks a judge to block the U.S. Health and Human Services Department from compelling the drugmaker to participate in the program. The company said its suit aims to stop the "innovation-damaging congressional overreach that threatens the United States' primacy in developing transformative therapies

Novartis stock jumps after drugmaker raises full-year guidance, launches $15 billion buyback

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[ad_1] Novartis said in August that it plans to spin off its generics unit Sandoz to sharpen its focus on its patented prescription medicines. Bloomberg | Bloomberg | Getty Images Novartis shares jumped on Tuesday after the Swiss drugmaker raised its full-year guidance on strong drug sales and announced a $15 billion share buyback.  The company made both announcements as it reported second-quarter earnings , which topped Wall Street's expectations.  related investing news The share buybacks will go to the end of 2025, Novartis said. The company, which is sitting on a large cash pile after selling its stake in Swiss rival Roche in 2021, completed an earlier buyback program of roughly the same size last month. Novartis expects sales to rise by a high-single-digit percentage in 2023, an increase from a previous expectation of mid-single-digit growth. The company also anticipates group core operating income will grow by a low double-digit percentage, up from a previous expec

FDA approves AstraZeneca, Sanofi shot that protects infants and toddlers against RSV

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[ad_1] Blood sample for respiratory syncytial virus (RSV) test Jarun011 | Istock | Getty Images The Food and Drug Administration on Monday approved AstraZeneca and Sanofi 's shot that protects infants and toddlers against respiratory syncytial virus , which is the leading cause of hospitalization among babies in the U.S. Nirsevimab is the first shot approved by the FDA to protect all infants against RSV regardless of whether they are healthy or have a medical condition. related investing news The FDA approval of nirsevimab, sold under the brand name Beyfortus, comes ahead of RSV season this fall. The Centers for Disease Control and Prevention's panel of independent experts will meet in August to make recommendations on how the shot should be administered by doctors. Another shot called palivizumab is already on the market, but it is given mainly to infants who are preterm or who have lung and congenital heart conditions that put them at high risk of severe disease. Nirs

Obesity drug maker Versanis to be bought by Eli Lilly for $1.9 billion

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[ad_1] Eli Lilly and Company, Pharmaceutical company headquarters in Alcobendas, Madrid, Spain. Cristina Arias | Cover | Getty Images Eli Lilly on Friday said it will acquire Versanis, a privately held obesity drug maker , for up to $1.93 billion to boost the pharmaceutical giant's weight loss treatment portfolio.  Eli Lilly agreed to pay Versanis shareholders in cash, which will consist of an upfront payment and potentially subsequent payments if Versanis achieves certain "development and sales milestones." Oakland, California-based Versanis, which was founded in 2021 by biotech investment firm Aditum Bio, has one experimental drug for obesity and potentially other conditions. Eli Lilly's stock price rose 3% on Friday following the announcement. The deal is Eli Lilly's latest attempt to capitalize on the weight loss industry gold rush, which began last year after Novo Nordisk' s blockbuster injections Wegovy and Ozempic boomed in popularity.  An est

FDA says soda sweetener aspartame is safe, disagreeing with WHO finding on possible cancer link

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[ad_1] Cans of PepsiCo's Pepsi Zero Sugar soda are displayed for an arranged photograph taken in Tiskilwa, Illinois, on Wednesday, April 17, 2019. Daniel Acker | Bloomberg | Getty Images The U.S. Food and Drug Administration disagrees with a World Health Organization finding that the widely used soda sweetener aspartame possibly causes cancer in humans, saying the studies used to reach that conclusion had "significant shortcomings." "Aspartame is one of the most studied food additives in the human food supply. FDA scientists do not have safety concerns when aspartame is used under the approved conditions," an agency spokesperson said late Thursday shortly after the WHO released its findings. The International Agency for Research on Cancer, a WHO body, found a possible link between aspartame and a type of liver cancer called hepatocellular carcinoma after reviewing three large human studies in the U.S. and Europe. Aspartame is used as a substitute for sugar

UnitedHealth stock jumps after earnings top estimates despite rising medical costs

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[ad_1] Representatives speak with customers at a UnitedHealthcare store in Queens, New York. Michael Nagle | Bloomberg | Getty Images UnitedHealth Group' s stock price jumped Friday after the health-care conglomerate reported second-quarter revenue and adjusted earnings that topped Wall Street's expectations despite rising medical costs . The results eased investor concerns after the Minnesota-based company flagged a surge in demand for non-urgent surgeries and outpatient services last month and spooked the market. related investing news UnitedHealth Group is the biggest health-care company in the U.S. by market cap and revenue, and is even bigger than the nation's largest banks. Given its size, UnitedHealth Group is considered a bellwether for the broader health insurance sector. Its market value was around $447 billion as of Friday afternoon. Here's what UnitedHealth Group reported compared with Wall Street's expectations, based on a survey of analysts by