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☆ Merck says experimental RSV treatment protected infants in trial, paving way for potential approval
▼ + stars: | 2024-10-17 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Merck plans to discuss the study data with regulators worldwide, with a goal of making the treatment available for infants as early as the 2025 to 2026 RSV season, according to a release. The trial examined the safety and efficacy of a single dose of the treatment, clesrovimab, in healthy preterm and full-term infants entering their first RSV season. Results were consistent through both the five-month and six-month time points in the trial, Merck said. Merck's clesrovimab could potentially compete against a similar treatment from Sanofi and AstraZeneca called Beyfortus, which was in short supply nationwide last RSV season due to unprecedented demand. But Merck's treatment can be administered to infants regardless of their weight, which the company said may offer convenience in terms of dosing.

Persons: Merck, Clesrovimab, Dr, Octavio Ramilo, Ramilo, Merck's Organizations: Merck, New York Stock Exchange, Infectious, Research, Sanofi, AstraZeneca, Pfizer, GSK Locations: Los Angeles, St

☆ Sanofi CEO under pressure to woo investors after spending shock
▼ + stars: | 2023-12-05 | by ( Ludwig Burger | ) www.reuters.com time to read: +5 min

[1/2] Paul Hudson, chief executive officer of Sanofi, speaks during the annual results news conference at the company's headquarters in Paris, France, February 4, 2022. The market's shock reaction, compounded by a lack of details of the spending push, overshadowed Sanofi's plan to list its consumer unit, in line with an industry trend. David Song, a portfolio manager and investment partner at Tema ETF, said: "The narrative of Sanofi has been a margin expansion, earnings-driven story for a lot of investors." "Shouldn't investors give credit to managements who care about long-term shareholder value creation?," said Song. ($1 = 0.9206 euros)Reporting by Ludwig Burger; Editing by Josephine Mason and Emelia Sithole-MatariseOur Standards: The Thomson Reuters Trust Principles.

Persons: Paul Hudson, Sanofi, Benoit Tessier, Hudson, Dan Lyons, Janus Henderson, Markus Manns, David Song, Fabian Wenner, Julius Baer, Union's Manns, Janus Henderson's Lyons, Johnson, Song, Ludwig Burger, Josephine Mason, Emelia Organizations: REUTERS, Reuters, Janus Henderson Investors, Germany's Union Investment, Tema, Thomson Locations: Paris, France, British, Hudson, Denver, Swiss, Tema

[1/4] Employees work in the manufacturing of Pfizer’s new respiratory syncytial virus (RSV) vaccine Abrysvo, in this undated handout picture. Pfizer/Handout via REUTERS Acquire Licensing RightsWASHINGTON, Nov 28 (Reuters) - Senior Biden administration officials met with RSV vaccine makers this week to underscore the need for manufacturers such as Sanofi (SASY.PA) and AstraZeneca (AZN.L) to urgently meet demand as winter approaches, the White House said on Tuesday. At a meeting at the White House on Monday, officials and manufacturers also agreed to plan now to meet next year's demand for the vaccines targeting respiratory syncytial virus, which generally causes mild, cold-like symptoms but can develop into severe illness in infants and older adults. "Monday's meeting follows numerous in-person and virtual meetings to seek ways manufacturers can make more RSV immunizations available for infants," the White House said in a statement. Reporting by Susan Heavey and Ahmed Aboulenein; Additional reporting by Mike Erman; Editing by Katharine Jackson and Nick ZieminskiOur Standards: The Thomson Reuters Trust Principles.

Persons: Susan Heavey, Ahmed Aboulenein, Mike Erman, Katharine Jackson, Nick Zieminski Organizations: Pfizer, Handout, REUTERS Acquire, Rights, Biden, Sanofi, AstraZeneca, White, U.S . Centers for Disease Control, Prevention, CDC, Thomson Locations: U.S

☆ CDC expedites release of more doses of infant RSV drug from Sanofi, AstraZeneca amid shortage
▼ + stars: | 2023-11-17 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The shortage – and other issues related to insurance coverage – threatens to prevent infants from receiving critical protection against RSV. Each year, the virus kills a few hundred children younger than 5, and 6,000 to 10,000 seniors, according to the CDC. RSV also causes around 58,000 to 80,000 hospitalizations among children younger than 5 years old each year, the CDC said. The U.S. started to see a sharp uptick in RSV cases in the middle of October. The U.S. suffered an unusually severe RSV season last year.

Persons: Sanofi, Nirav Shah Organizations: Disease Control, U.S, Sanofi, AstraZeneca, CDC, Vaccines, Children Program, Food and Drug Administration, FDA Locations: U.S

☆ Sanofi loses $21 bln in market value after dropping 2025 profit target
▼ + stars: | 2023-10-27 | by ( Ludwig Burger | ) www.reuters.com time to read: +6 min

Under a push to spend more on immunology and inflammation drug development, the company abandoned a target for a 32% operating profit margin for 2025 to focus on "long-term profitability". EPS would see a strong rebound in 2025 but not enough to sustain the previous margin target. CONSUMER STAND-ALONECEO Hudson said the core innovative drugs business had improved enough to soon do without the more predictable cash flows from consumer products. The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. The timing of the potential consumer listing, which Sanofi said would be in the fourth quarter of 2024 or later, would be set to maximize shareholder value.

Persons: Hudson, Sanofi, drugmaker, Paul Hudson, Terence McManus, Johnson, we've, Gonzalo Fuentes, Roche, Dupixent, Ludwig Burger, Sherry Jacob, Phillips, Mark Potter, Sharon Singleton Organizations: Sanofi, Bellevue Asset Management, Reuters, Barclays, Johnson, GSK, Pfizer, Bayer, Polyclonals, REUTERS, Provention, Merck & Co, Thomson Locations: France, Bellevue, Lyon, Paris

☆ New RSV Drug Has Limited Supply, CDC Says
▼ + stars: | 2023-10-24 | by ( Joseph Pisani | ) www.wsj.com time to read: 1 min

A Beyfortus injection helps infants neutralize the virus. Photo: AstraZeneca/Associated PressThe Centers for Disease Control and Prevention is warning that there’s a limited supply of a new drug that protects babies from RSV, a common but potentially deadly respiratory virus. The U.S. health agency is recommending doctors give it to infants at high risk first.

Organizations: AstraZeneca, Associated, Disease Control Locations: U.S

NEW YORK (AP) — A new shot for infants against RSV is in short supply, and U.S. health officials told doctors they should prioritize giving the drug to babies at the highest risk of severe disease. The larger doses are for larger, heavier infants. Supply of the smaller doses also may be limited during the current RSV season, CDC officials said. The CDC said doctors should not use two smaller doses on larger infants, so as to preserve the supply of those shots. Some children may be eligible for an older RSV drug, palivizumab, agency officials said.

Persons: Sanofi, there's Organizations: Centers for Disease Control, AstraZeneca, Sanofi, U.S . Food, Drug Administration, CDC, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S, United States

☆ New RSV protections for infants hit cost, insurance hurdles in U.S. rollout
▼ + stars: | 2023-10-13 | by ( Angelica Peebles | In Angelicapeebles | ) www.cnbc.com time to read: +2 min

Two new immunizations promise to protect babies from respiratory syncytial virus – if people can find them. Providers are scrambling to offer Pfizer's vaccine, Abrysvo, to pregnant patients and Sanofi's monoclonal antibody, Beyfortus, to babies. Until now, the only preventative treatment was another monoclonal antibody called Synagis that's given once a month during RSV season, which generally runs from fall through spring. Sanofi's Beyfortus is a monoclonal antibody that's given directly to babies and provides them with immediate protection. "I know that [RSV]'s a threat to little babies, and so to have an opportunity to prevent illness in the first place is really exciting."

Persons: Michael Chamberlin, hasn't, we're, Chamberlin, that's, Erin Bakke, Graham Organizations: Pediatric Associates Locations: Carmel, Cincinnati , Ohio

☆ CDC advisors recommend Pfizer maternal RSV vaccine to protect infants
▼ + stars: | 2023-09-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Pfizer's vaccine, called Abrysvo, is already approved and available in the U.S. for adults ages 60 and up. The panel's recommendation puts Pfizer's maternal shot on track to reach the public as RSV begins to spread at higher levels. But younger children and older adults are particularly vulnerable to more severe RSV infections. Each year, the virus kills a few hundred children younger than 5, and 6,000 to 10,000 seniors, according to the CDC. RSV also causes around 58,000 to 80,000 hospitalizations among children younger than 5 years old each year, the CDC said.

Persons: Pfizer, Mandy Cohen, Luis Jodar, Pfizer's Abrysvo, Jefferson Jones, Jones Organizations: Disease Control, U.S, Public, CDC, Pfizer, Northern, Drug Administration, FDA, AstraZeneca Locations: U.S, Sanofi

☆ Explainer: What you need to know about RSV and the new vaccines
▼ + stars: | 2023-09-22 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

That Pfizer (PFE.N) shot and one developed by GSK (GSK.L) in May became the first two RSV vaccines to win U.S. approval, for use in people aged 60 and over to prevent severe illness. Still, infants and older adults have a higher risk of developing severe RSV. RSV leads to 58,000 to 80,000 hospitalizations among children under age 5, and 60,000 to 160,000 hospitalizations among adults age 65 and older each year, according to the CDC. Early data suggests that the RSV shots are protective for at least two years, but it is not yet clear how often older adults will need to be revaccinated. Can I get the RSV shot alongside my COVID and flu shots?

Persons: Pfizer's, Synagis, it's, Jeffrey Duchin, you've, Michael Erman, Bhanvi, Caroline Humer, Bill Berkrot Organizations: . Centers for Disease Control, Prevention, Pfizer, GSK, CDC, FDA, Sanofi, AstraZeneca, Infectious Diseases Society of America, CVS, Humana, Thomson Locations: U.S, Aetna, New York, Bengaluru Edtiting

☆ It's Time to Start Preparing Against Flu, RSV & COVID-19
▼ + stars: | 2023-09-15 | by ( Sept. | At A.M. | ) www.usnews.com time to read: +5 min

The flu vaccine is now available in some locations. And new respiratory syncytial virus (RSV) vaccines are recommended for some. "We should do what we can to protect ourselves — and others — with the best tool we have: the flu vaccine." Not only that, but COVID-19 and RSV could again spike at the same time as the flu, triggering a "tripledemic," Gandhi said. Women who are between 32 and 36 weeks pregnant can also protect their infants at birth by getting a new Pfizer RSV vaccine.

Persons: Cara Murez HealthDay, Soniya Gandhi, Gandhi, There's, Priya Soni, Sinai Guerin Children’s, Soni, Sonja Rosen, Rosen Organizations: Southern Hemisphere, U.S . Food, Drug Administration, Pfizer, GSK, U.S . Centers for Disease Control Locations: United States, Cedars, Sinai, Los Angeles, U.S, Guillain, Barre

WASHINGTON (AP) — Updated COVID-19 vaccines are coming soon, just in time to pair them with flu shots. Approval of updated COVID-19 shots is expected within days. Political Cartoons View All 1148 ImagesHere is what you need to know about fall vaccinations:WHY MORE COVID-19 SHOTS? Earlier this month, European regulators authorized Pfizer’s updated vaccine for this fall, for adults and children as young as 6 months. CAN I GET A FLU SHOT AND COVID-19 SHOT AT THE SAME TIME?

Persons: Mandy Cohen, haven’t, “, ”, David Montefiori, it's, Carla K, Johnson Organizations: WASHINGTON, Centers for Disease Control, CDC, Food and Drug Administration, Pfizer, Moderna, FDA, Duke, WHO, GSK, AstraZeneca, AP, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group Locations: Novavax, Sanofi

☆ Infant RSV shot faces final hurdle at CDC, could be available by fall
▼ + stars: | 2023-08-03 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

CDC Director Mandy Cohen is not obligated to endorse the vote of the advisors, though the head of the agency usually follows the panel's advice. Beyfortus, also called nirsevimab, is set to become the first shot in the U.S. that protects all infants from RSV. Sanofi has said the companies are prepared to roll the shot out before RSV season this fall and do not foresee any challenges meeting demand. Although Beyfortus works like a vaccine, the shot is considered a drug, not a vaccine, because it is an antibody injection. Advisors are also voting Thursday on whether Beyfortus should be included in the Vaccines for Children program, making the votes a crucial step for the drug.

Persons: Mandy Cohen Organizations: Centers for Disease Control, Sanofi, Children, Advisors, Vaccines Locations: U.S

☆ US CDC panel recommends Sanofi-AstraZeneca's preventive RSV therapy for babies
▼ + stars: | 2023-08-03 | by ( ) www.reuters.com time to read: +1 min

[1/2] Sanofi logo at the company's headquarters during the annual results news conference in Paris, France, February 4, 2022. REUTERS/Benoit Tessier/File PhotoCompanies AstraZeneca PLC FollowSanofi SA FollowAug 3 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said its advisory panel on Thursday recommended use of Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers. The Advisory Committee on Immunization Practices unanimously recommended nirsevimab for preventing lower respiratory tract disease in newborns and infants below eight months of age born during or entering their first RSV season. It also recommended its use in children aged 8-19 months who remain vulnerable to severe RSV disease through their second such season. The therapy, branded as Beyfortus, will be available in the U.S. ahead of the upcoming 2023-24 RSV season, Sanofi said.

Persons: Benoit Tessier, AstraZeneca's, Sanofi, Mrinmay Dey, Mariam Sunny Organizations: Sanofi, REUTERS, Companies AstraZeneca, U.S . Centers for Disease Control, Prevention, U.S . Food, Drug Administration, Thomson Locations: Paris, France, U.S, Bengaluru

☆ Sanofi expects infant RSV shot to roll out before respiratory virus season this fall
▼ + stars: | 2023-07-21 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

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. The Sanofi spokesperson said the company does not expect any challenges with manufacturing or capacity to meet demand this RSV season. Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. Nearly 100 infants die every year in the U.S. from the virus, according to a study last year.

Persons: Sanofi, Beyfortus, Biden Organizations: Drug Administration, Sanofi, AstraZeneca, Centers for Disease Control, Children Locations: U.S, French, England

☆ US FDA approves Sanofi-AstraZeneca's preventive RSV therapy for babies
▼ + stars: | 2023-07-17 | by ( ) www.reuters.com time to read: +2 min

July 17 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Monday it had approved Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers. The therapy, branded Beyfortus, was approved for preventing lower respiratory tract disease in infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second such season. The companies plan to make Beyfortus available in the United States ahead of the upcoming RSV season, Sanofi said, adding that it plans to share more information about the therapy's price closer to the season. RSV is a leading cause of hospitalizations in infants and so far Swedish Orphan Biovitrum's (SOBIV.ST) treatment, Synagis, was the only approved preventive therapy in the United States for high-risk infants. The therapy comes with warnings and precautions about serious hypersensitivity reactions, and should be given with caution to infants and children with clinically significant bleeding disorders, the FDA said.

Persons: AstraZeneca's, Sanofi, Beyfortus, Bhanvi Satija, Shinjini Ganguli, Maju Samuel Organizations: U.S . Food, Drug Administration, Sanofi, American Academy of Pediatrics, FDA, Thomson Locations: U.S, United States, Bengaluru

☆ F.D.A. Approves R.S.V. Shot for Infants
▼ + stars: | 2023-07-17 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections for an illness that fills children’s hospitals year after year. The monoclonal antibody shot is expected to be available at the start of the fall R.S.V. vaccine by Pfizer for pregnant women that is meant to protect infants from the virus. can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” Dr. John Farley, an official in the F.D.A. “Today’s approval addresses the great need for products to help reduce the impact of R.S.V.

Persons: ” Dr, John Farley, “ Organizations: Drug Administration, Pfizer, Sanofi, AstraZeneca, Centers for Disease Control, Center, Drug, Research

☆ FDA approves AstraZeneca, Sanofi shot that protects infants and toddlers against RSV
▼ + stars: | 2023-07-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The FDA approval of nirsevimab, sold under the brand name Beyfortus, comes ahead of RSV season this fall. This is a major advantage over palivizumab, which is administered monthly throughout RSV season. Nirsevimab is administered either before or during an infant's first RSV season. Toddlers up to two years old who remain vulnerable can also receive the shot during their second RSV season. Pfizer has developed a vaccine that protects infants by administering the shot to the mother while she is pregnant.

Persons: Biden, Nirsevimab Organizations: Drug Administration, AstraZeneca, Sanofi, FDA, Disease Control, Children, CDC, Pfizer Locations: U.S, Nirsevimab

☆ Sanofi, Regeneron unveil 'blow-out' smoker's lung drug data
▼ + stars: | 2023-03-23 | by ( Ludwig Burger Jubabu | Ludwig Burger | ) www.reuters.com time to read: +4 min

Sanofi and Regeneron said in a statement on Thursday a Phase III trial involving 939 current or former smokers also showed improvements in lung function, quality of life and COPD respiratory symptoms. JP Morgan analyst Richard Vosser said the trial update had "blow-out data" in store for investors, and that market consensus for 2027 Dupixent sales of 15.7 billion euros would likely be topped-up by between 1 and 2 billion euros. The anti-inflammatory drug accounted for 8.3 billion euros, or more than 19% of the French group's overall sales of 43 billion euros, last year. Sanofi reports combined global Dupixent sales from its alliance with Regeneron. Sanofi and Regeneron on Tuesday announced the European Commission had approved Dupixent to treat severe atopic dermatitis in young children.

☆ Sanofi forecasts moderate profit growth on Dupixent demand
▼ + stars: | 2023-02-03 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

Feb 3 (Reuters) - Sanofi (SASY.PA) on Friday forecast moderate earnings growth this year, saying higher demand for bestselling asthma and eczema drug Dupixent would be partly offset by competition for its multiple sclerosis pill Aubagio and product launch costs. Aubagio, with 2 billion euros in sales last year, will face competition from cheaper products over the next few months after losing patent protection, Sanofi said. The company reaffirmed its target to achieve sales of Dupixent, jointly developed with Regeneron (REGN.O), of 10 billion euros this year, up more than 20% from 8.29 billion euros in 2022. Sanofi reported a 20.7% rise in fourth-quarter business operating income, or adjusted earnings before interest and tax, to 2.72 billion euros ($2.96 billion), edging past an average analyst estimate of 2.69 billion euros posted on the company's website. Revenue from Dupixent surged 42% to 2.4 billion euros during the quarter ended Dec. 31, slightly above a consensus of 2.37 billion euros.

☆ Explainer: COVID, flu and RSV this U.S. winter: Why experts are worried
▼ + stars: | 2022-10-26 | by ( Nancy Lapid | ) www.reuters.com time to read: +3 min

REUTERS/Carlo Allegri/File PhotoOct 26 (Reuters) - U.S. doctors are warning that a surge in cases of respiratory syncytial virus (RSV) is coinciding with an increase in COVID transmission and an earlier-than-normal flu season, raising the specter of a "tripledemic" of respiratory illness this winter. In particular, RSV infections among young children are reportedly filling some U.S. hospitals to capacity. Older children and most adults typically experience mild, cold-like symptoms. In the meantime, it is important "for everyone to get up to date on their COVID and flu vaccines," Varma said. Part of the increase in RSV cases is due to the relaxation of COVID-precautions, such as masking and social distancing, which reduced rates of both RSV and flu during the pandemic, Varma said.

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