FDA: Two Monoclonal Antibody Treatments Ineffective Against Omicron Variant
The FDA has removed two monoclonal antibody therapies from its list of emergency authorized COVID-19 treatments due to their ineffectiveness against the Omicron variant.
Tag: pharmaceuticals
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Teva Launches Generic Nasal Spray to Treat Overdoses
Teva says its generic version of the nasal spray Narcan is the first to arrive on the market.
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Izana Bioscience’s Therapeutic May Treat COVID-19 Pneumonia
The trial tested namilumab as a potential therapeutic to treat patients who are hospitalized with COVID-19 pneumonia.
Positive Data for Co-administered Flu Vaccine and COVID-19 Vaccine
Positive results from the first co-administration study of a SARS-CoV-2 vaccine candidate and an approved influenza vaccine have been published in The Lancet Respiratory Medicine.
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FDA Expands Authorization of Moderna, Pfizer Boosters to All Americans 18+
The FDA expanded emergency use for both the Moderna and Pfizer-BioNTech COVID-19 vaccine boosters for all individuals 18 years of age and older.
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Regen-Cov Protects Against COVID-19 for up to Eight Months
A single dose of Regeneron Pharma’s antibody cocktail casirivimab and imdevimab (trade name Regen-Cov) reduced the risk of COVID-19 by 81.6% for up to eight months, according to a Phase 3 trial.
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IBD Patients Had Strong Antibody Response to COVID Vaccine
New research shows patients with inflammatory bowel disease (IBD) produced a strong antibody response to COVID-19 vaccination.
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Majority of Patients with Prior Allergic Reactions Can Still Receive COVID-19 Vaccine
Researchers say that most people who think they will have an allergic reaction, or who believe they have had an allergic response to the first vaccine, can safely be fully vaccinated.
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Pfizer COVID-19 Antiviral Pill Paxlovid Reduced Hospitalization, Mortality
Pfizer says its antiviral pill Paxlovid reduced the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19.
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Subcutaneous Interferon Does Not Improve Outcomes for Hospitalized Adults with COVID-19
A clinical trial has found that treatment with the immunomodulator interferon beta-1a plus the antiviral remdesivir was not superior to treatment with remdesivir alone in hospitalized adults with COVID-19 pneumonia.
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FDA Authorizes Pfizer COVID-19 Vaccine in Children Ages 5-11
For children 5-11, the Pfizer-BioNTech COVID-19 vaccine is administered as a two-dose primary series, 3 weeks apart, but in a lower dose (10 μg).
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FDA Advisory Committee Supports Pfizer VAccine for Kids Age 5-11
An FDA vaccine advisory committee voted 17 to 0 to recommend the emergency use of the Pfizer/BioNTech COVID-19 vaccine in children 5 to <12 years of age.
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Merck to License COVID-19 Antiviral to Drugmakers in Other Companies
Merck has entered into a voluntary licensing agreement to allow the production of its investigational COVID-19 antiviral molnupiravir by drugmakers in 105 low- and middle-income countries.
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Novavax Pursuing UK Authorization for COVID-19 Vaccine
Novavax has completed its rolling regulatory submission for authorization of its NVX-CoV2373 COVID-19 vaccine candidate in the United Kingdom.
Read MorePositive Data for Moderna COVID-19 Vaccine in Children Ages 6-11
Two 50 μg doses of Moderna’s vaccine mRNA-1273 was generally well tolerated in children ages 6-11, who generated antibody levels 1.5 times greater than young adults in the study.
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