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A vial labelled "Novavax V COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. Still, the Maryland-based biotech, which has been banking on cost cuts and commercial sales of its retooled COVID shot to help it stay afloat, reiterated its "going concern warning". The company expects the 2023-2024 U.S. market for COVID shots to be between 30 million and 50 million doses. The company's updated COVID shot, using a more traditional technology than the mRNA-based vaccines of rivals Pfizer (PFE.N) and Moderna (MRNA.O), was authorized in the U.S. in October. Novavax missed out on the COVID vaccine windfall that benefited rivals due to manufacturing issues that delayed its filing for approval when the pandemic was raging.

Persons: Dado Ruvic, Novavax, Jim Kelly, John Jacobs, Jacobs, Bhanvi, Patrick Wingrove, Sriraj Kalluvila, Bill Berkrot Organizations: REUTERS, U.S, Department of Health, Human Services, Pfizer, Moderna, Thomson Locations: Maryland, U.S, United States, Bengaluru, New York

The FDA approved tirzepatide for weight loss under the brand name Zepbound. It has been available as Mounjaro for type 2 diabetes since 2022 and had increasingly been used "off-label" for weight loss while the obesity approval was pending. Zepbound will be available in the U.S. by the end of the year at a list price of $1,059.87 a month, according to Lilly. That compares with a list of $1,349 per-package for Novo Nordisk's (NOVOb.CO) wildly popular weight-loss drug Wegovy. After Wednesday's FDA approval, Lilly can now promote the drug for weight loss.

Persons: Eli Lilly, Mike Segar, Eli Lilly's, ” John Sharretts, Lilly, Morningstar, Damien Conover, Conover, drugmaker, Robert Kushner, Mounjaro, Patrick Wingrove, Leroy Leo, Bhanvi, Shinjini Ganguli, Bill Berkrot Organizations: Company, REUTERS, U.S . Food, Drug Administration, U.S, FDA, FDA’s Center, Drug, Research, Novo Nordisk's, Reuters, Northwestern University Feinberg School of Medicine, Thomson Locations: Branchburg , New Jersey, U.S, Indianapolis, United States, New York, Bengaluru

Aug 21 (Reuters) - The U.S. Food and Drug Administration on Monday approved Pfizer's (PFE.N) respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies. An FDA panel of outside experts backed the safety and effectiveness of Pfizer's RSV vaccine for women in their second and third trimesters earlier in May. RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalization. Infants are at greatest risk for severe illness from RSV. An estimated 58,000 to 80,000 children below the age of five years are hospitalized every year due to RSV infection in the U.S., according to government data.

Persons: Pfizer, Mariam Sunny, Bhanvi, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: U.S . Food, Drug Administration, FDA, Pfizer, U.S . Centers for Disease Control, Sanofi, AstraZeneca, GSK, Thomson Locations: U.S, United States, Bengaluru, New York

Although insulin list prices are high in the U.S., drugmakers typically pay substantial rebates to private insurers and government programs, resulting in lower prices for most Americans with insurance. U.S.-listed Novo Nordisk shares rose as much as 1.7% to $142.95, while Denmark-listed shares closed marginally higher on Tuesday. Eli Lilly shares were down slightly. "I think it is a relatively natural consequence of what we have seen their competitor Eli Lilly do. Eli Lilly, Sanofi and Novo Nordisk make up 90% of the U.S. market for insulin.

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