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Analysis Chemical Thank You EPA issues guidance for disinfectant product claims used on soft surface textiles in non-residential settings

Agency IQ

Commenters also provided edits to both the virus and bacterial methods, as well as the claim and use sites. Stakeholders were also concerned about the interpretation and clarity of the term “porous surface.” One was for use against viruses and one was for combating bacteria. Other concerns focused on guidance and label language.

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Therma Bright Acquires 100% Control of its COVID-19 Rapid Saliva Antigen Test and Announces Proposed Name Change for the Test

The Pharma Data

” Therma Bright is not making any express or implied claims that its product, SCV2, has the ability to eliminate or cure COVID-19 (or SARS-CoV-2 virus). The test can help identify infected individuals in 15 minutes and is designed for at-home or point-of-need settings such as long-term care facilities, schools, or sporting events.

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U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older

The Pharma Data

Today’s ACIP recommendation follows the December 1, 2020 ACIP recommendation for a Phase 1a rollout in which the first priority for COVID-19 vaccines is given to healthcare personnel treating patients and residents in long-term care facilities. Department of Health and Human Services (HHS) for review and adoption.

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Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

The Pharma Data

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly subsequently developed bamlanivimab and etesevimab for administration together, in order to meet the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone.

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Drop in COVID Cases Seen in Nursing Homes as U.S. Vaccine Effort Makes Headway

The Pharma Data

million shots have now been administered in long-term care facilities, according to the U.S. The variant is perhaps the most worrisome to public health experts, because it seems to have some ability to evade COVID-19 antibody treatments or vaccines. “I’m optimistic, this is good.”

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Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19

The Pharma Data

Lilly submitted a request for an EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients to the FDA in early October. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19. Food and Drug Administration (FDA).

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Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19

The Pharma Data

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. Preliminary analyses show similar adverse events in the placebo and treatment arms.

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